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A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01872689
Recruitment Status : Completed
First Posted : June 7, 2013
Results First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Interventions Drug: Lebrikizumab
Drug: Pirfenidone
Drug: Placebo
Enrollment 505
Recruitment Details  
Pre-assignment Details A total of 505 participants (154 participants in Monotherapy Cohort and 351 participants in Combination Therapy Cohort) were enrolled in the study.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description Participants received monotherapy with placebo matched to lebrikizumab administered via subcutaneous (SC) injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 milligrams (mg) administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period. Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period. Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at maximum tolerated dose (MTD) administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Period Title: Double-Blind/Placebo-Controlled Period
Started 76 78 177 174
Completed 56 58 129 136
Not Completed 20 20 48 38
Reason Not Completed
Lack of Efficacy             0             1             0             0
Other             1             1             6             3
Withdrawal by Subject             9             8             14             16
Protocol Violation             0             0             1             1
Physician Decision             0             3             3             1
Lost to Follow-up             1             0             0             1
Death             3             4             14             9
Adverse Event             6             3             10             7
Period Title: Open-Label Period (Only For Monotherapy)
Started 52 [1] 56 [2] 0 [3] 0 [3]
Completed 31 33 0 0
Not Completed 21 23 0 0
Reason Not Completed
Other             2             3             0             0
Withdrawal by Subject             11             12             0             0
Physician Decision             0             1             0             0
Lost to Follow-up             1             3             0             0
Death             5             3             0             0
Adverse Event             2             1             0             0
[1]
Of the 56 participants who completed Period 1, only 52 started Period 2.
[2]
Of the 58 participants who completed Period 1, only 56 started Period 2.
[3]
As per study design, Period 2 was not intended for this arm.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone Total
Hide Arm/Group Description Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period. Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period. Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Total of all reporting groups
Overall Number of Baseline Participants 76 78 177 174 505
Hide Baseline Analysis Population Description
Analysis was performed on Intent-to-Treat (ITT) Population, which included all participants who were randomized in the study, with participants grouped according to the treatment assignment at randomization.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 76 participants 78 participants 177 participants 174 participants 505 participants
From 40 to <55 years 2 1 6 2 11
From 55 to <65 years 18 10 40 41 109
From 65 to <75 years 38 44 99 92 273
>/=75 years 18 23 32 39 112
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 78 participants 177 participants 174 participants 505 participants
Female
13
  17.1%
13
  16.7%
30
  16.9%
37
  21.3%
93
  18.4%
Male
63
  82.9%
65
  83.3%
147
  83.1%
137
  78.7%
412
  81.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 78 participants 177 participants 174 participants 505 participants
Hispanic or Latino
9
  11.8%
6
   7.7%
13
   7.3%
15
   8.6%
43
   8.5%
Not Hispanic or Latino
64
  84.2%
68
  87.2%
160
  90.4%
155
  89.1%
447
  88.5%
Unknown or Not Reported
3
   3.9%
4
   5.1%
4
   2.3%
4
   2.3%
15
   3.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 78 participants 177 participants 174 participants 505 participants
American Indian or Alaska Native
1
   1.3%
1
   1.3%
0
   0.0%
1
   0.6%
3
   0.6%
Asian
11
  14.5%
8
  10.3%
19
  10.7%
15
   8.6%
53
  10.5%
Native Hawaiian or Other Pacific Islander
1
   1.3%
0
   0.0%
1
   0.6%
0
   0.0%
2
   0.4%
Black or African American
0
   0.0%
0
   0.0%
1
   0.6%
1
   0.6%
2
   0.4%
White
60
  78.9%
66
  84.6%
149
  84.2%
151
  86.8%
426
  84.4%
More than one race
0
   0.0%
1
   1.3%
0
   0.0%
0
   0.0%
1
   0.2%
Unknown or Not Reported
3
   3.9%
2
   2.6%
7
   4.0%
6
   3.4%
18
   3.6%
1.Primary Outcome
Title Annualized Rate of Decrease in Percent Predicted Forced Vital Capacity (FVC) Over 52 Weeks
Hide Description Annualized rates of decrease (slope throughout time from baseline to Week 52) for percent predicted FVC was assessed and reported. FVC is a standard pulmonary function test. FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC (in %) = [(observed FVC)/(predicted FVC)]*100.
Time Frame Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 53 56 120 134
Mean (Standard Error)
Unit of Measure: percent predicted FVC/year
-6.1876  (0.92597) -5.2065  (0.92758) -6.0430  (0.60633) -5.5430  (0.59507)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Monotherapy (Cohort A): Placebo, Monotherapy (Cohort A): Lebrikizumab
Comments Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4555
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.98111
Confidence Interval (2-Sided) 95%
-1.61 to 3.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.31064
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combination Therapy (Cohort B): Placebo + Pirfenidone, Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Comments Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5566
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.49998
Confidence Interval (2-Sided) 95%
-1.17 to 2.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.84946
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Annualized Rate of Decline in 6-Minute Walk Test (6MWT) Distance Over 52 Weeks
Hide Description Annualized rates of decline (slope throughout time from baseline to Week 52) in 6MWT was assessed and reported. 6MWT was the distance (in meters [m]) that a participant could walk in 6 minutes.
Time Frame Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 52 59 120 129
Mean (Standard Error)
Unit of Measure: m/year
-44.6512  (15.97862) -22.7209  (15.34753) -25.5683  (12.24923) -46.9810  (11.84199)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Monotherapy (Cohort A): Placebo, Monotherapy (Cohort A): Lebrikizumab
Comments Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3129
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 21.93023
Confidence Interval (2-Sided) 95%
-20.97 to 64.83
Parameter Dispersion
Type: Standard Error of the Mean
Value: 21.62248
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combination Therapy (Cohort B): Placebo + Pirfenidone, Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Comments Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2036
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -21.4127
Confidence Interval (2-Sided) 95%
-54.50 to 11.67
Parameter Dispersion
Type: Standard Error of the Mean
Value: 16.80160
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Event of Greater Than or Equal to (>/=) 10% Absolute Decline in Percent Predicted FVC or Death From Any Cause
Hide Description FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC (in %) = [(observed FVC)/(predicted FVC)]*100.
Time Frame Baseline up to the event of >/=10% absolute decline in percent predicted FVC or death from any cause, whichever occurred first (up to Week 122)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 76 76 175 173
Measure Type: Number
Unit of Measure: percentage of participants
34.2 27.6 30.3 26.6
4.Secondary Outcome
Title Time to First Occurrence of a >/=10% Absolute Decline in Percent Predicted FVC or Death From Any Cause
Hide Description FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC (in %) = [(observed FVC)/(predicted FVC)]*100. Time from randomization to first occurrence of an event of >/=10% absolute decline in percent predicted FVC or death from any cause was reported. Participants without an event were censored at the last assessment during the double-blind treatment period. Any participant who underwent lung transplantation was censored at the date of the transplant. The median time to event was estimated using Kaplan-Meier method. 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.
Time Frame Baseline up to the event of >/=10% absolute decline in percent predicted FVC or death from any cause, whichever occurred first (up to Week 122)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 76 76 175 173
Median (95% Confidence Interval)
Unit of Measure: weeks
53.1 [1] 
(52.6 to NA)
NA [2] 
(NA to NA)
NA [3] 
(52.9 to NA)
NA [2] 
(NA to NA)
[1]
Upper limit of 95% CI could not be estimated due to high number of censored participants.
[2]
Median and corresponding 95% CI could not be estimated due to high number of censored participants.
[3]
Median and upper limit of 95% CI could not be estimated due to high number of censored participants.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Monotherapy (Cohort A): Placebo, Monotherapy (Cohort A): Lebrikizumab
Comments Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4299
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.44 to 1.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combination Therapy (Cohort B): Placebo + Pirfenidone, Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Comments Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3751
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.56 to 1.24
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Annualized Rate of Decrease in Diffusion Capacity of the Lung for Carbon Monoxide (DLco) Over 52 Weeks
Hide Description Annualized rates of decrease (slope throughout time from baseline to Week 52) in DLco was assessed and reported. DLco (in milliliters per minute/millimeters of mercury [mL/min/mmHg]) is a measure of the gas transfer.
Time Frame Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 50 52 112 122
Mean (Standard Error)
Unit of Measure: mL/min/mmHg/year
-4.7818  (0.74479) -4.2400  (0.73826) -5.7552  (0.46561) -5.5732  (0.45577)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Monotherapy (Cohort A): Placebo, Monotherapy (Cohort A): Lebrikizumab
Comments Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6075
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.54171
Confidence Interval (2-Sided) 95%
-1.54 to 2.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.05201
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combination Therapy (Cohort B): Placebo + Pirfenidone, Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Comments Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7803
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18203
Confidence Interval (2-Sided) 95%
-1.10 to 1.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.65206
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Event of Death, All Cause Hospitalization, or a Decrease From Baseline of >/=10% in FVC
Hide Description FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC = [(observed FVC)/(predicted FVC)]*100.
Time Frame Baseline up to the event of death from any cause, all cause hospitalization, or a decrease from baseline of >/=10% in FVC, whichever occurred first (up to Week 122)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 76 76 175 173
Measure Type: Number
Unit of Measure: percentage of participants
47.4 32.9 39.4 39.9
7.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC = [(observed FVC)/(predicted FVC)]*100. PFS was defined as time from randomization to death from any cause, all cause hospitalization, or a decrease from baseline of >/=10% in FVC, whichever occurred first. Participants without an event were censored at the last assessment during the double-blind treatment period. Any participant who underwent lung transplantation was censored at the date of the transplant. The median PFS was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame Baseline up to the event of death from any cause, all cause hospitalization, or a decrease from baseline of >/=10% in FVC, whichever occurred first (up to Week 122)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 76 76 175 173
Median (95% Confidence Interval)
Unit of Measure: weeks
52.6 [1] 
(43.9 to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [3] 
(52.3 to NA)
[1]
Upper limit of 95% CI could not be estimated due to high number of censored participants.
[2]
Median and corresponding 95% CI could not be estimated due to high number of censored participants.
[3]
Median and upper limit of 95% CI could not be estimated due to high number of censored participants.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Monotherapy (Cohort A): Placebo, Monotherapy (Cohort A): Lebrikizumab
Comments Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0972
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.39 to 1.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combination Therapy (Cohort B): Placebo + Pirfenidone, Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Comments Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9344
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.72 to 1.42
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Annualized Rate of Decrease in FVC Over 52 Weeks
Hide Description Annualized rates of decrease (slope throughout time from baseline to Week 52) in FVC (in milliliters per year [mL/year]) was assessed and reported. FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position.
Time Frame Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 53 57 120 134
Mean (Standard Error)
Unit of Measure: mL/year
-221.029  (34.87511) -192.906  (34.93853) -231.167  (22.67786) -209.437  (22.25073)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Monotherapy (Cohort A): Placebo, Monotherapy (Cohort A): Lebrikizumab
Comments Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5707
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 28.12302
Confidence Interval (2-Sided) 95%
-69.80 to 126.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 49.47253
Estimation Comments Mean Difference = Lebrikizumab - Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combination Therapy (Cohort B): Placebo + Pirfenidone, Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Comments Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4934
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 21.72972
Confidence Interval (2-Sided) 95%
-40.65 to 84.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 31.68767
Estimation Comments Mean Difference = Lebrikizumab - Placebo
9.Secondary Outcome
Title Annualized Rate of Decrease in A Tool to Assess Quality of Life in IPF (ATAQ-IPF) Questionnaire Total Score Over 52 Weeks
Hide Description The ATAQ-IPF Version 3 was utilized that included 31 items within 5 domains: cough (6 items), dyspnea (7 items), exhaustion (6 items), emotional well-being (6 items), and independence (6 items). Each item was assessed on a scale ranging from 1 (Strongly disagree) to 4 (Strongly agree). The ATAQ-IPF had a recall specification of 2 weeks. Simple summation scoring was used to derive individual domain scores as well as a total score. ATAQ-IPF total score ranged from 31 to 124 with lower score indicating better quality of life (QoL). Annualized rates of decrease (slope throughout time from baseline to Week 52) in ATAQ-IPF questionnaire total score was assessed and reported.
Time Frame Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 58 62 136 144
Mean (Standard Error)
Unit of Measure: units on a scale/year
6.8907  (1.71778) 4.7886  (1.70370) 5.6189  (0.99880) 5.4558  (0.97793)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Monotherapy (Cohort A): Placebo, Monotherapy (Cohort A): Lebrikizumab
Comments Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3854
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -2.10204
Confidence Interval (2-Sided) 95%
-6.88 to 2.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.41325
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combination Therapy (Cohort B): Placebo + Pirfenidone, Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Comments Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9057
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.16313
Confidence Interval (2-Sided) 95%
-2.87 to 2.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.37698
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With an Event of St. George's Respiratory Questionnaire (SGRQ) Total Score Worsening or Death From Any Cause
Hide Description The SGRQ is a 50-item health-related QoL instrument that measured health impairment. The questionnaire contains 3 domains: symptoms, activity, and impacts. Items were assessed on various response scales, including a 5-point Likert scale and True/False scale. The SGRQ had a recall specification of 4 weeks. The SGRQ total score (summed weights) ranged from 0 to 100 with a lower score denoting a better health status. Percentage of participants with an event of SGRQ total score worsening (defined as reaching minimal important difference [MID], that is, an increase in total score of >/=7) or death from any cause was reported.
Time Frame Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT Population for monotherapy cohort only. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab
Hide Arm/Group Description:
Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Overall Number of Participants Analyzed 76 76
Measure Type: Number
Unit of Measure: percentage of participants
57.9 48.7
11.Secondary Outcome
Title Time to First Occurrence of SGRQ Total Score Worsening or Death From Any Cause
Hide Description The SGRQ is a 50-item health-related QoL instrument that measured health impairment. The questionnaire contains 3 domains: symptoms, activity, and impacts. Items were assessed on various response scales, including a 5-point Likert scale and True/False scale. The SGRQ had a recall specification of 4 weeks. The SGRQ total score (summed weights) ranged from 0 to 100 with a lower score denoting a better health status. Time from randomization to first occurrence of an event of SGRQ total score worsening (defined as reaching minimal important difference [MID], that is, an increase in total score of >/=7) or death from any cause was reported. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT Population for monotherapy cohort only. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab
Hide Arm/Group Description:
Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Overall Number of Participants Analyzed 76 76
Median (95% Confidence Interval)
Unit of Measure: weeks
51.7
(24.1 to 54.6)
52.3 [1] 
(35.7 to NA)
[1]
Upper limit of 95% CI could not be estimated due to high number of censored participants.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Monotherapy (Cohort A): Placebo, Monotherapy (Cohort A): Lebrikizumab
Comments Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4433
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.54 to 1.31
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants With an Event of Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Hide Description IPF exacerbation was defined as an event that met all of the following criteria as determined by the investigator: Unexplained worsening or development of dyspnea within the previous 30 days; And radiologic evidence of new bilateral ground-glass abnormality or consolidation, superimposed on a reticular or honeycomb background pattern, that is consistent with usual interstitial pneumonitis; And absence of alternative causes, such as left heart failure, pulmonary embolism, pulmonary infection (on the basis of endotracheal aspirate or bronchoalveolar lavage if available, or investigator judgment), or other events leading to acute lung injury (for example, sepsis, aspiration, trauma, reperfusion pulmonary edema).
Time Frame Baseline up to the event of acute IPF exacerbation (up to Week 122)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 76 76 175 172
Measure Type: Number
Unit of Measure: percentage of participants
3.9 3.9 6.3 2.9
13.Secondary Outcome
Title Time to First Event of Acute IPF Exacerbation
Hide Description Time from randomization to first occurrence of an event of IPF exacerbation was reported. IPF exacerbation was defined as an event that met all of the following criteria as determined by the investigator: Unexplained worsening or development of dyspnea within the previous 30 days; And radiologic evidence of new bilateral ground-glass abnormality or consolidation, superimposed on a reticular or honeycomb background pattern, that is consistent with usual interstitial pneumonitis; And absence of alternative causes, or other events leading to acute lung injury. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame Baseline up to the event of acute IPF exacerbation (up to Week 122)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 76 76 175 172
Median (95% Confidence Interval)
Unit of Measure: weeks
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and corresponding 95% CI could not be estimated due to high number of censored participants.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Monotherapy (Cohort A): Placebo, Monotherapy (Cohort A): Lebrikizumab
Comments Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9366
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.21 to 5.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combination Therapy (Cohort B): Placebo + Pirfenidone, Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Comments Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1346
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.16 to 1.31
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants With Respiratory-Related Hospitalization
Hide Description [Not Specified]
Time Frame Baseline up to the event of respiratory-related hospitalization (up to Week 122)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT Population for combination therapy cohorts only. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 175 173
Measure Type: Number
Unit of Measure: percentage of participants
15.4 14.5
15.Secondary Outcome
Title Time to Respiratory-Related Hospitalization
Hide Description Time from randomization to first occurrence of an event of respiratory-related hospitalization was reported. Participants without an event were censored at the last known alive day, study Day 368, or the last date during the double-blind period. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame Baseline up to the event of respiratory-related hospitalization (up to Week 122)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT Population for combination therapy cohorts only. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 175 173
Median (95% Confidence Interval)
Unit of Measure: weeks
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and corresponding 95% CI could not be estimated due to high number of censored participants.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combination Therapy (Cohort B): Placebo + Pirfenidone, Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Comments Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6815
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.52 to 1.54
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Participants With an Event of >/=15% Absolute Decrease in Percentage of Predicted DLco or Death From Any Cause
Hide Description DLco (in mL/min/mmHg) is a measure of the gas transfer. Predicted DLco is based on sex, age, and height of a person. Percent of predicted DLco (in %) = [(observed DLco)/(predicted DLco)]*100.
Time Frame Baseline up to the event of >/=15% absolute decrease in percentage of predicted DLco or death from any cause (up to Week 122)
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Hide Analysis Population Description
Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 76 76 175 173
Measure Type: Number
Unit of Measure: percentage of participants
9.2 6.6 14.9 11.0
17.Secondary Outcome
Title Time to First Event of >/=15% Absolute Decrease in Percentage of Predicted DLco or Death From Any Cause
Hide Description DLco is a measure of the gas transfer. Predicted DLco is based on sex, age, and height of a person. Percent of predicted DLco (in %) = [(observed DLco)/(predicted DLco)]*100. Time from randomization to first occurrence of >/=15% absolute decrease in percentage of predicted DLco or death from any cause was reported. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame Baseline up to the event of >/=15% absolute decrease in percentage of predicted DLco or death from any cause (up to Week 122)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 76 76 175 173
Median (95% Confidence Interval)
Unit of Measure: weeks
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and corresponding 95% CI could not be estimated due to high number of censored participants.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Monotherapy (Cohort A): Placebo, Monotherapy (Cohort A): Lebrikizumab
Comments Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5685
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.23 to 2.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combination Therapy (Cohort B): Placebo + Pirfenidone, Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Comments Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1976
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.37 to 1.23
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants With Anti-therapeutic Antibody (ATA) to Lebrikizumab
Hide Description ATA to lebrikizumab was tested using a validated immunoassay. A positive ATA result was defined as one in which the presence of detectable ATAs could be confirmed by competitive binding with lebrikizumab. Percentage of participants with positive results for ATA at Baseline and at post-baseline time points were reported. Only participants who received lebrikizumab were included in the analysis.
Time Frame Baseline and Post-Baseline (assessed at multiple time points: Weeks 4, 12, 24, 36, 52, 56, 64, 76, and at safety follow-up up to Week 122)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety Population (all participants who received at least one dose of study drug grouped according to the actual treatment received). 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure; 'Number Analyzed' = number of participants evaluable at indicated time points.
Arm/Group Title Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 75 172
Measure Type: Number
Unit of Measure: percentage of participants
Baseline Number Analyzed 75 participants 171 participants
5.3 1.8
Post-Baseline Number Analyzed 75 participants 172 participants
6.7 5.2
19.Secondary Outcome
Title Minimum Observed Serum Concentration (Cmin) of Lebrikizumab at Week 52
Hide Description Participants who received lebrikizumab were only included in the analysis.
Time Frame Predose (Hour 0) at Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Pharmacokinetic (PK)-Evaluable Population, which included all participants who received at least one dose of study drug and had at least one non-missing PK observation. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.
Arm/Group Title Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 62 137
Mean (Standard Deviation)
Unit of Measure: micrograms per milliliter (mcg/mL)
29.6  (14.0) 25.2  (12.7)
20.Secondary Outcome
Title Minimum Observed Serum Concentration (Cmin) of Lebrikizumab
Hide Description Participants who received lebrikizumab were only included in the analysis.
Time Frame Predose (Hour 0) at Weeks 4, 12, 24, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK-Evaluable Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.
Arm/Group Title Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 78 174
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Cmin at Week 4 Number Analyzed 74 participants 170 participants
14.0  (4.86) 14.9  (5.75)
Cmin at Week 12 Number Analyzed 68 participants 165 participants
24.4  (9.86) 25.0  (11.0)
Cmin at Week 24 Number Analyzed 65 participants 153 participants
28.5  (12.5) 25.7  (12.4)
Cmin at Week 36 Number Analyzed 61 participants 146 participants
29.9  (14.1) 25.6  (13.8)
21.Secondary Outcome
Title Elimination Half-Life (t1/2) of Lebrikizumab
Hide Description Elimination half-life is the time measured for the plasma drug concentration to decrease by one-half during the elimination phase of the drug. Analysis was performed on PK-Evaluable Population. Participants who received lebrikizumab were only included in the analysis.
Time Frame Pre-dose (Hour 0) at Weeks 1, 4, 12, 24, 36, 64, 76, 88, 104; and at 4, 12, and 18 weeks post-last dose (last dose = Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK-Evaluable Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description:
Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Overall Number of Participants Analyzed 35 125
Mean (Standard Deviation)
Unit of Measure: days
23.5  (5.36) 21.9  (4.79)
Time Frame Baseline up to Week 122
Adverse Event Reporting Description Safety Population
 
Arm/Group Title Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Hide Arm/Group Description Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period. Participants received monotherapy with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period. Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants received pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
All-Cause Mortality
Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/76 (5.26%)   4/78 (5.13%)   15/177 (8.47%)   7/174 (4.02%) 
Hide Serious Adverse Events
Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/76 (25.00%)   23/78 (29.49%)   47/177 (26.55%)   56/174 (32.18%) 
Cardiac disorders         
Acute coronary syndrome * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Acute myocardial infarction * 1  1/76 (1.32%)  1/78 (1.28%)  0/177 (0.00%)  1/174 (0.57%) 
Angina pectoris * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Atrial fibrillation * 1  0/76 (0.00%)  1/78 (1.28%)  2/177 (1.13%)  1/174 (0.57%) 
Atrial flutter * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Atrioventricular block * 1  0/76 (0.00%)  1/78 (1.28%)  0/177 (0.00%)  0/174 (0.00%) 
Atrioventricular block second degree * 1  0/76 (0.00%)  1/78 (1.28%)  0/177 (0.00%)  0/174 (0.00%) 
Bradycardia * 1  0/76 (0.00%)  1/78 (1.28%)  0/177 (0.00%)  0/174 (0.00%) 
Cardiac arrest * 1  0/76 (0.00%)  1/78 (1.28%)  0/177 (0.00%)  0/174 (0.00%) 
Cardio-respiratory arrest * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Cardiac failure * 1  0/76 (0.00%)  2/78 (2.56%)  3/177 (1.69%)  1/174 (0.57%) 
Cardiomegaly * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Coronary artery disease * 1  2/76 (2.63%)  0/78 (0.00%)  2/177 (1.13%)  2/174 (1.15%) 
Coronary artery occlusion * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Myocardial ischaemia * 1  0/76 (0.00%)  1/78 (1.28%)  3/177 (1.69%)  0/174 (0.00%) 
Right ventricular failure * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Tachycardia * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  0/174 (0.00%) 
Ear and labyrinth disorders         
Vertigo positional * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Gastrointestinal disorders         
Diarrhoea * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  0/174 (0.00%) 
Diverticulum intestinal haemorrhagic * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Gastritis * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  0/174 (0.00%) 
Gastrooesophageal reflux disease * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Inguinal hernia * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Intestinal prolapse * 1  0/76 (0.00%)  1/78 (1.28%)  0/177 (0.00%)  0/174 (0.00%) 
Mesenteric vein thrombosis * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Nausea * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Pancreatitis * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  2/174 (1.15%) 
Pancreatitis acute * 1  2/76 (2.63%)  0/78 (0.00%)  0/177 (0.00%)  0/174 (0.00%) 
Toothache * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  0/174 (0.00%) 
Vomiting * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
General disorders         
Chest pain * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Death * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Multiple organ dysfunction syndrome * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Sudden death * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  0/174 (0.00%) 
Hepatobiliary disorders         
Drug-induced liver injury * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  2/174 (1.15%) 
Immune system disorders         
Graft versus host disease * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Infections and infestations         
Bronchitis * 1  0/76 (0.00%)  1/78 (1.28%)  1/177 (0.56%)  0/174 (0.00%) 
Bronchitis bacterial * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Bronchopulmonary aspergillosis * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Campylobacter infection * 1  0/76 (0.00%)  1/78 (1.28%)  0/177 (0.00%)  0/174 (0.00%) 
Diverticulitis * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  0/174 (0.00%) 
Erysipelas * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Fungal infection * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
H1N1 influenza * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Influenza * 1  1/76 (1.32%)  1/78 (1.28%)  0/177 (0.00%)  0/174 (0.00%) 
Lower respiratory tract infection * 1  1/76 (1.32%)  4/78 (5.13%)  2/177 (1.13%)  1/174 (0.57%) 
Lung infection * 1  0/76 (0.00%)  1/78 (1.28%)  1/177 (0.56%)  2/174 (1.15%) 
Pneumonia * 1  2/76 (2.63%)  3/78 (3.85%)  7/177 (3.95%)  7/174 (4.02%) 
Pneumonia bacterial * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Pneumonia haemophilus * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  0/174 (0.00%) 
Pneumonia influenzal * 1  0/76 (0.00%)  1/78 (1.28%)  0/177 (0.00%)  0/174 (0.00%) 
Pneumonia viral * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Postoperative wound infection * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Respiratory syncytial virus infection * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Respiratory tract infection * 1  1/76 (1.32%)  1/78 (1.28%)  3/177 (1.69%)  5/174 (2.87%) 
Sepsis * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Septic shock * 1  0/76 (0.00%)  1/78 (1.28%)  0/177 (0.00%)  1/174 (0.57%) 
Urinary tract infection enterococcal * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Wound infection bacterial * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Mycobacterium avium complex infection * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Urinary tract infection * 1  0/76 (0.00%)  2/78 (2.56%)  0/177 (0.00%)  0/174 (0.00%) 
Injury, poisoning and procedural complications         
Fall * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Procedural hypotension * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Procedural pain * 1  1/76 (1.32%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Radius fracture * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Spinal fracture * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Investigations         
Blood creatine phosphokinase increased * 1  0/76 (0.00%)  1/78 (1.28%)  0/177 (0.00%)  0/174 (0.00%) 
Hepatic enzyme increased * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Dehydration * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Hypercalcaemia * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Hyponatraemia * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Musculoskeletal and connective tissue disorders         
Back pain * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Musculoskeletal chest pain * 1  0/76 (0.00%)  1/78 (1.28%)  0/177 (0.00%)  0/174 (0.00%) 
Musculoskeletal pain * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Rheumatoid arthritis * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  1/174 (0.57%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Basosquamous carcinoma * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  0/174 (0.00%) 
Chondrosarcoma * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  0/174 (0.00%) 
Hepatic cancer * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Hepatocellular carcinoma * 1  0/76 (0.00%)  1/78 (1.28%)  0/177 (0.00%)  0/174 (0.00%) 
Lung Adenocarcinoma Stage IV * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Lung Neoplasm * 1  0/76 (0.00%)  1/78 (1.28%)  1/177 (0.56%)  0/174 (0.00%) 
Lung neoplasm malignant * 1  0/76 (0.00%)  1/78 (1.28%)  0/177 (0.00%)  0/174 (0.00%) 
Lung squamous cell carcinoma Stage 0 * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  0/174 (0.00%) 
Neuroendocrine carcinoma * 1  0/76 (0.00%)  1/78 (1.28%)  0/177 (0.00%)  0/174 (0.00%) 
Pancreatic carcinoma metastatic * 1  0/76 (0.00%)  1/78 (1.28%)  0/177 (0.00%)  0/174 (0.00%) 
Plasma cell myeloma * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  0/174 (0.00%) 
Squamous cell carcinoma * 1  0/76 (0.00%)  1/78 (1.28%)  3/177 (1.69%)  1/174 (0.57%) 
Squamous cell carcinoma of skin * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Nervous system disorders         
Carotid artery stenosis * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Cerebrovascular accident * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Epilepsy * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Ischaemic stroke * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Presyncope * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  0/174 (0.00%) 
Syncope * 1  1/76 (1.32%)  1/78 (1.28%)  1/177 (0.56%)  1/174 (0.57%) 
Psychiatric disorders         
Delirium * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure * 1  2/76 (2.63%)  1/78 (1.28%)  1/177 (0.56%)  1/174 (0.57%) 
Haemoptysis * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Hyperventilation * 1  0/76 (0.00%)  1/78 (1.28%)  0/177 (0.00%)  0/174 (0.00%) 
Hypoxia * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  3/174 (1.72%) 
Idiopathic pulmonary fibrosis * 1  13/76 (17.11%)  11/78 (14.10%)  22/177 (12.43%)  17/174 (9.77%) 
Oropharyngeal discomfort * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Pleural effusion * 1  0/76 (0.00%)  1/78 (1.28%)  1/177 (0.56%)  0/174 (0.00%) 
Pneumomediastinum * 1  2/76 (2.63%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Pneumothorax * 1  2/76 (2.63%)  2/78 (2.56%)  0/177 (0.00%)  1/174 (0.57%) 
Pulmonary arterial hypertension * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Pulmonary embolism * 1  3/76 (3.95%)  2/78 (2.56%)  1/177 (0.56%)  2/174 (1.15%) 
Pulmonary fibrosis * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  1/174 (0.57%) 
Pulmonary hypertension * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Respiratory failure * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Dyspnoea * 1  2/76 (2.63%)  1/78 (1.28%)  1/177 (0.56%)  1/174 (0.57%) 
Skin and subcutaneous tissue disorders         
Angioedema * 1  0/76 (0.00%)  0/78 (0.00%)  1/177 (0.56%)  0/174 (0.00%) 
Vascular disorders         
Aortic aneurysm * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Aortic stenosis * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
Axillary vein thrombosis * 1  1/76 (1.32%)  0/78 (0.00%)  0/177 (0.00%)  0/174 (0.00%) 
Hypotension * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  2/174 (1.15%) 
Orthostatic hypotension * 1  0/76 (0.00%)  0/78 (0.00%)  0/177 (0.00%)  1/174 (0.57%) 
1
Term from vocabulary, MedDRA Version 20.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Monotherapy (Cohort A): Placebo Monotherapy (Cohort A): Lebrikizumab Combination Therapy (Cohort B): Placebo + Pirfenidone Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   70/76 (92.11%)   73/78 (93.59%)   158/177 (89.27%)   142/174 (81.61%) 
Eye disorders         
Cataract * 1  2/76 (2.63%)  4/78 (5.13%)  7/177 (3.95%)  4/174 (2.30%) 
Dry eye * 1  0/76 (0.00%)  4/78 (5.13%)  1/177 (0.56%)  3/174 (1.72%) 
Gastrointestinal disorders         
Abdominal discomfort * 1  2/76 (2.63%)  4/78 (5.13%)  3/177 (1.69%)  3/174 (1.72%) 
Abdominal pain * 1  3/76 (3.95%)  4/78 (5.13%)  2/177 (1.13%)  1/174 (0.57%) 
Abdominal pain upper * 1  4/76 (5.26%)  4/78 (5.13%)  4/177 (2.26%)  6/174 (3.45%) 
Constipation * 1  11/76 (14.47%)  11/78 (14.10%)  12/177 (6.78%)  14/174 (8.05%) 
Diarrhoea * 1  16/76 (21.05%)  17/78 (21.79%)  23/177 (12.99%)  18/174 (10.34%) 
Dry mouth * 1  0/76 (0.00%)  6/78 (7.69%)  2/177 (1.13%)  4/174 (2.30%) 
Dyspepsia * 1  2/76 (2.63%)  4/78 (5.13%)  5/177 (2.82%)  8/174 (4.60%) 
Flatulence * 1  0/76 (0.00%)  4/78 (5.13%)  1/177 (0.56%)  1/174 (0.57%) 
Gastrooesophageal reflux disease * 1  2/76 (2.63%)  3/78 (3.85%)  9/177 (5.08%)  9/174 (5.17%) 
Nausea * 1  10/76 (13.16%)  10/78 (12.82%)  23/177 (12.99%)  28/174 (16.09%) 
Toothache * 1  4/76 (5.26%)  0/78 (0.00%)  2/177 (1.13%)  1/174 (0.57%) 
Vomiting * 1  6/76 (7.89%)  3/78 (3.85%)  9/177 (5.08%)  8/174 (4.60%) 
General disorders         
Asthenia * 1  2/76 (2.63%)  5/78 (6.41%)  3/177 (1.69%)  0/174 (0.00%) 
Chest discomfort * 1  5/76 (6.58%)  2/78 (2.56%)  3/177 (1.69%)  3/174 (1.72%) 
Chest pain * 1  5/76 (6.58%)  7/78 (8.97%)  7/177 (3.95%)  10/174 (5.75%) 
Fatigue * 1  12/76 (15.79%)  15/78 (19.23%)  22/177 (12.43%)  28/174 (16.09%) 
Injection site erythema * 1  1/76 (1.32%)  4/78 (5.13%)  1/177 (0.56%)  1/174 (0.57%) 
Oedema peripheral * 1  2/76 (2.63%)  4/78 (5.13%)  4/177 (2.26%)  3/174 (1.72%) 
Pain * 1  2/76 (2.63%)  4/78 (5.13%)  2/177 (1.13%)  1/174 (0.57%) 
Pyrexia * 1  2/76 (2.63%)  6/78 (7.69%)  5/177 (2.82%)  1/174 (0.57%) 
Infections and infestations         
Bronchitis * 1  11/76 (14.47%)  15/78 (19.23%)  11/177 (6.21%)  17/174 (9.77%) 
Influenza * 1  4/76 (5.26%)  5/78 (6.41%)  10/177 (5.65%)  3/174 (1.72%) 
Lower respiratory tract infection * 1  5/76 (6.58%)  11/78 (14.10%)  13/177 (7.34%)  10/174 (5.75%) 
Nasopharyngitis * 1  19/76 (25.00%)  17/78 (21.79%)  25/177 (14.12%)  31/174 (17.82%) 
Pneumonia * 1  3/76 (3.95%)  1/78 (1.28%)  9/177 (5.08%)  3/174 (1.72%) 
Respiratory tract infection * 1  5/76 (6.58%)  4/78 (5.13%)  9/177 (5.08%)  8/174 (4.60%) 
Rhinitis * 1  4/76 (5.26%)  4/78 (5.13%)  7/177 (3.95%)  2/174 (1.15%) 
Sinusitis * 1  5/76 (6.58%)  6/78 (7.69%)  9/177 (5.08%)  11/174 (6.32%) 
Upper respiratory tract infection * 1  13/76 (17.11%)  18/78 (23.08%)  38/177 (21.47%)  31/174 (17.82%) 
Urinary tract infection * 1  5/76 (6.58%)  9/78 (11.54%)  11/177 (6.21%)  6/174 (3.45%) 
Injury, poisoning and procedural complications         
Fall * 1  6/76 (7.89%)  4/78 (5.13%)  3/177 (1.69%)  6/174 (3.45%) 
Investigations         
Forced vital capacity decreased * 1  4/76 (5.26%)  11/78 (14.10%)  6/177 (3.39%)  6/174 (3.45%) 
Weight decreased * 1  5/76 (6.58%)  2/78 (2.56%)  9/177 (5.08%)  11/174 (6.32%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  5/76 (6.58%)  9/78 (11.54%)  22/177 (12.43%)  17/174 (9.77%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  9/76 (11.84%)  9/78 (11.54%)  8/177 (4.52%)  10/174 (5.75%) 
Back pain * 1  9/76 (11.84%)  12/78 (15.38%)  11/177 (6.21%)  11/174 (6.32%) 
Muscle spasms * 1  5/76 (6.58%)  6/78 (7.69%)  4/177 (2.26%)  2/174 (1.15%) 
Musculoskeletal chest pain * 1  1/76 (1.32%)  5/78 (6.41%)  2/177 (1.13%)  1/174 (0.57%) 
Musculoskeletal pain * 1  10/76 (13.16%)  5/78 (6.41%)  8/177 (4.52%)  2/174 (1.15%) 
Nervous system disorders         
Dizziness * 1  10/76 (13.16%)  14/78 (17.95%)  14/177 (7.91%)  11/174 (6.32%) 
Headache * 1  9/76 (11.84%)  10/78 (12.82%)  17/177 (9.60%)  11/174 (6.32%) 
Psychiatric disorders         
Anxiety * 1  5/76 (6.58%)  3/78 (3.85%)  1/177 (0.56%)  2/174 (1.15%) 
Insomnia * 1  3/76 (3.95%)  7/78 (8.97%)  4/177 (2.26%)  8/174 (4.60%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  19/76 (25.00%)  21/78 (26.92%)  46/177 (25.99%)  33/174 (18.97%) 
Dysphonia * 1  0/76 (0.00%)  4/78 (5.13%)  1/177 (0.56%)  0/174 (0.00%) 
Dyspnoea * 1  12/76 (15.79%)  14/78 (17.95%)  18/177 (10.17%)  13/174 (7.47%) 
Dyspnoea exertional * 1  4/76 (5.26%)  6/78 (7.69%)  4/177 (2.26%)  5/174 (2.87%) 
Idiopathic pulmonary fibrosis * 1  13/76 (17.11%)  11/78 (14.10%)  10/177 (5.65%)  9/174 (5.17%) 
Oropharyngeal pain * 1  7/76 (9.21%)  4/78 (5.13%)  5/177 (2.82%)  2/174 (1.15%) 
Productive cough * 1  3/76 (3.95%)  8/78 (10.26%)  8/177 (4.52%)  6/174 (3.45%) 
Sinus congestion * 1  1/76 (1.32%)  5/78 (6.41%)  1/177 (0.56%)  2/174 (1.15%) 
Skin and subcutaneous tissue disorders         
Photosensitivity reaction * 1  6/76 (7.89%)  3/78 (3.85%)  24/177 (13.56%)  7/174 (4.02%) 
Pruritus * 1  2/76 (2.63%)  3/78 (3.85%)  12/177 (6.78%)  8/174 (4.60%) 
Rash * 1  5/76 (6.58%)  9/78 (11.54%)  21/177 (11.86%)  18/174 (10.34%) 
Vascular disorders         
Hypertension * 1  4/76 (5.26%)  4/78 (5.13%)  4/177 (2.26%)  7/174 (4.02%) 
1
Term from vocabulary, MedDRA Version 20.1
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01872689    
Other Study ID Numbers: GB28547
2013-001163-24 ( EudraCT Number )
First Submitted: June 5, 2013
First Posted: June 7, 2013
Results First Submitted: July 24, 2018
Results First Posted: August 24, 2018
Last Update Posted: August 24, 2018