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Trial record 35 of 62 for:    Baricitinib

A Phase 2b Study of Baricitinib in Participants With Moderate to Severe Psoriasis

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ClinicalTrials.gov Identifier: NCT01490632
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : July 18, 2017
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Interventions Drug: Placebo
Drug: Baricitinib
Enrollment 271
Recruitment Details Participant Psoriasis Area and Severity Index (PASI) score at the conclusion of Part A stratified participants as either Responder (PASI ≥75), Partial Responder (PASI 50 - PASI 74), or Non-Responder (PASI <50).
Pre-assignment Details Part A: Initial Treatment Period (Weeks 0 up to 12) Part B: Extension or Step-Up Period (Week 12 up to Week 24) Part C: Washout or Step-Down Period (Week 24 up to Week 40) Part D: (Re-Treatment Period up to 52 Weeks)
Arm/Group Title Part A: Placebo Part A: Baricitinib 2 mg Part A: Baricitinib 4 mg Part A: Baricitinib 8 mg Part A: Baricitinib 10 mg Part B: Responder - Low Dose Part B: Responder - High Dose Part B: Partial- and Non-responder - Placebo to High Dose Part B: Partial-responder - Low Dose to Low Dose Part B: Partial- and Non-responder - Low Dose to High Dose Part B: Partial- and Non-responder - High Dose to High Dose Part B: Placebo Extension Part C: Responder - Low Dose to Placebo Part C: Responder - Low Dose to ½ Low Dose Part C: Responder - High Dose to Placebo Part C: Responder - High Dose to Low Dose Part D: Baricitinib 2 mg - Retreatment Part D: Baricitinib 4 mg - Retreatment Part D: Baricitinib 8 mg - Retreatment Part D: Baricitinib 10 mg - Retreatment
Hide Arm/Group Description Placebo administered orally (PO) once daily (QD) for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks. Baricitinib 2 milligram (mg) administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks. Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks. Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks. Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study. Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively. Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively. Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD. Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose. Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD. Baricitinib administered 8 mg or 10 mg PO QD. Placebo PO QD maintained on placebo PO QD. Baricitinib 2 mg or 4 mg PO QD re-randomized to placebo PO QD. Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 1 mg or 2 mg PO QD. Baricitinib administered 8 mg or 10 mg PO QD re-randomized to placebo PO QD. Baricitinib administered 8 mg PO QD re-randomized to baricitinib 4 mg PO QD. Baricitinib administered 10 mg PO QD re-randomized to baricitinib 4 mg PO QD. Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks. Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks. Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks. Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Period Title: Part A: Initial Treatment Period
Started 34 32 72 64 69 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Received at Least One Dose of Study Drug 34 32 72 64 69 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Completed 27 28 67 55 52 [1] 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 7 4 5 9 17 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             0             0             2             4             4             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Lack of Efficacy             3             1             2             2             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Lost to Follow-up             0             0             1             1             2             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Physician Decision             0             1             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Sponsor Decision             2             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             2             2             0             1             2             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Discontinued at Week 12 per protocol             0             0             0             0             9             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
[1]
Includes participants who completed Part A, but discontinued per protocol using Part A PASI score.
Period Title: Part B: Extension or Step-Up Period
Started 0 [1] 0 [1] 0 [1] 0 [1] 0 [1] 29 [2] 64 [3] 19 [4] 16 [5] 50 [6] 43 [7] 8 [8] 0 0 0 0 0 0 0 0
Completed 0 0 0 0 0 25 51 13 6 25 22 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 4 13 6 10 25 21 8 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             0             0             0             0             0             2             2             0             0             2             3             1             0             0             0             0             0             0             0             0
Lack of Efficacy             0             0             0             0             0             0             1             0             1             3             1             0             0             0             0             0             0             0             0             0
Lost to Follow-up             0             0             0             0             0             0             2             0             0             1             0             0             0             0             0             0             0             0             0             0
Physician Decision             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0
Sponsor Decision             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             0             1             0             1             0             1             2             0             0             0             0             0             0             0             0
Completed Part B and Not Moving to PartC             0             0             0             0             0             1             6             6             8             19             16             5             0             0             0             0             0             0             0             0
[1]
See Recruitment Details for explanation of Part B participant assignment.
[2]
Part A participants randomized to 2 mg or 4 mg with a PASI ≥75 remained on 2 mg or 4 mg.
[3]
Part A participants randomized to 8 mg or 10 mg with a PASI ≥75 remained on 8 mg or 10 mg.
[4]
Placebo participants in Part A with a PASI <75 were re-randomized to 8 mg or 10 mg.
[5]
Part A participants randomized to 2 mg or 4 mg with a PASI ≥50 to <75 remained on 2 mg or 4 mg.
[6]
Part A participants randomized to 2 mg or 4 mg with a PASI <50 were re-randomized to 8 mg or 10 mg.
[7]
Part A 10 mg non-responders were discontinued from the study.
[8]
Part A participants randomized to Placebo remained on Placebo.
Period Title: Part C: Washout or Step-Down Period
Started 0 0 0 0 0 [1] 0 [2] 0 [3] 0 [4] 0 [5] 0 [6] 0 [7] 0 [8] 15 [9] 16 [10] 55 [11] 55 [12] 0 0 0 0
Completed 0 0 0 0 0 0 0 0 0 0 0 0 10 6 37 18 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 5 10 18 37 0 0 0 0
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             0             0             0             0             0             0             0             2             2             0             0             0             0
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             0             0             0             0             2             1             0             0             0             0
Did Not Qualify for Part D Per Protocol             0             0             0             0             0             0             0             0             0             0             0             0             5             9             14             34             0             0             0             0
[1]
One participant completed Part B but discontinued without receiving a Part C treatment assignment.
[2]
Part A participants randomized to 2 mg or 4 mg with a PASI ≥75 remained on 2 mg or 4 mg.
[3]
Part A participants randomized to 8 mg or 10 mg with a PASI ≥75 remained on 8 mg or 10 mg.
[4]
Placebo participants in Part A with a PASI <75 were re-randomized to 8 mg or 10 mg.
[5]
Part A participants randomized to 2 mg or 4 mg with a PASI ≥50 to <75 remained on 2 mg or 4 mg.
[6]
Part A participants randomized to 2 mg or 4 mg with a PASI <50 were re-randomized to 8 mg or 10 mg.
[7]
Part A 10 mg non-responders were discontinued from the study.
[8]
Part A participants randomized to Placebo remained on Placebo.
[9]
Responders receiving 2 or 4 mg were re-randomized to receive placebo.
[10]
Responders receiving 2 or 4 mg were re-randomized to receive half of the dose from Part B.
[11]
Responders receiving 8 or 10 mg were re-randomized to receive placebo.
[12]
Responders receiving 8 or 10 mg were re-randomized to receive 4 mg.
Period Title: Part D: Re-Treatment Period
Started 0 0 0 0 0 0 0 0 0 0 0 0 0 [1] 0 [2] 0 [3] 0 [4] 3 [5] 13 [6] 19 [7] 37 [8]
Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 8 12 30
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 7 7
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             1             3
Death             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0
Lack of Efficacy             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             3             1             2
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0
Physician Decision             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             1
Protocol Violation             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             1             1
[1]
Responders receiving 2 or 4 mg were re-randomized to receive placebo.
[2]
Responders receiving 2 or 4 mg were re-randomized to receive half of the dose from Part B.
[3]
Responders receiving 8 or 10 mg were re-randomized to receive placebo.
[4]
Responders receiving 8 or 10 mg were re-randomized to receive 4 mg.
[5]
Responders who experienced a relapse or flare proceeded for retreatment with 2 mg.
[6]
Responders who experienced a relapse or flare proceeded for retreatment with 4 mg.
[7]
Responders who experienced a relapse or flare proceeded for retreatment with 8 mg.
[8]
Responders who experienced a relapse or flare proceeded for retreatment with 10 mg.
Arm/Group Title Part A: Placebo Part A: Baricitinib 2 mg Part A: Baricitinib 4 mg Part A: Baricitinib 8 mg Part A: Baricitinib 10 mg Total
Hide Arm/Group Description Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks. Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks. Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks. Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks. Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study. Total of all reporting groups
Overall Number of Baseline Participants 34 32 72 64 69 271
Hide Baseline Analysis Population Description
All randomized participants who received at least one dose of study drug.
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 32 participants 72 participants 64 participants 69 participants 271 participants
46.70  (15.144) 47.81  (15.165) 47.21  (11.650) 47.37  (15.829) 47.43  (10.425) 47.31  (13.268)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 72 participants 64 participants 69 participants 271 participants
Female
11
  32.4%
9
  28.1%
18
  25.0%
18
  28.1%
18
  26.1%
74
  27.3%
Male
23
  67.6%
23
  71.9%
54
  75.0%
46
  71.9%
51
  73.9%
197
  72.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 72 participants 64 participants 69 participants 271 participants
Hispanic or Latino
4
  11.8%
6
  18.8%
11
  15.3%
12
  18.8%
10
  14.5%
43
  15.9%
Not Hispanic or Latino
30
  88.2%
26
  81.3%
61
  84.7%
52
  81.3%
59
  85.5%
228
  84.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 72 participants 64 participants 69 participants 271 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.6%
0
   0.0%
1
   0.4%
Asian
7
  20.6%
6
  18.8%
12
  16.7%
9
  14.1%
11
  15.9%
45
  16.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.9%
0
   0.0%
1
   1.4%
1
   1.6%
4
   5.8%
7
   2.6%
White
26
  76.5%
26
  81.3%
58
  80.6%
52
  81.3%
53
  76.8%
215
  79.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.6%
1
   1.4%
2
   0.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   1.4%
0
   0.0%
0
   0.0%
1
   0.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 72 participants 64 participants 69 participants 271 participants
Japan
4
  11.8%
4
  12.5%
9
  12.5%
8
  12.5%
8
  11.6%
33
  12.2%
North America
30
  88.2%
28
  87.5%
63
  87.5%
56
  87.5%
61
  88.4%
238
  87.8%
Duration of Psoriasis (Ps)  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 32 participants 72 participants 64 participants 69 participants 271 participants
16.42  (14.297) 15.00  (9.951) 19.90  (12.766) 16.56  (11.948) 16.60  (10.653) 17.26  (11.995)
Percent Body Surface Area (BSA) Affected by Psoriasis  
Mean (Standard Deviation)
Unit of measure:  Percent of BSA
Number Analyzed 34 participants 32 participants 72 participants 64 participants 69 participants 271 participants
23.18  (11.890) 30.78  (20.523) 28.61  (18.797) 28.23  (15.726) 24.45  (12.079) 27.04  (16.101)
Baseline Psoriasis Area and Severity Index (PASI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a Scale
Number Analyzed 34 participants 32 participants 72 participants 64 participants 69 participants 271 participants
19.06  (6.805) 21.36  (11.056) 20.58  (9.438) 20.24  (7.827) 19.01  (6.177) 20.00  (8.228)
[1]
Measure Description: The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.
1.Primary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
Hide Description The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema (redness), and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.
Time Frame Week 12
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Hide Analysis Population Description
North American (NA) modified intent-to-treat (mITT) population: All NA randomized participants who received at least one dose of study drug. Non-responders and participants who discontinued study drug any time prior to time point of interest, or discontinued from study, were defined as non-responders for the non-responder imputation (NRI) analysis.
Arm/Group Title Part A: Placebo Part A: Baricitinib 2 mg Part A: Baricitinib 4 mg Part A: Baricitinib 8 mg Part A: Baricitinib 10 mg
Hide Arm/Group Description:
Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Overall Number of Participants Analyzed 30 28 63 56 61
Measure Type: Number
Unit of Measure: Percent of Participants
16.7 28.6 28.6 42.9 54.1
2.Secondary Outcome
Title Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])
Hide Description The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.
Arm/Group Title Part A: Placebo Part A: Baricitinib 2 mg Part A: Baricitinib 4 mg Part A: Baricitinib 8 mg Part A: Baricitinib 10 mg
Hide Arm/Group Description:
Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Overall Number of Participants Analyzed 34 32 72 64 69
Measure Type: Number
Unit of Measure: Percent of Participants
14.7 15.6 25.0 29.7 34.8
3.Secondary Outcome
Title Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])
Hide Description The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.
Arm/Group Title Part B: Responder - Low Dose Part B: Responder - High Dose Part B: Partial- and Non-responder - Placebo to High Dose Part B: Partial-responder - Low Dose to Low Dose Part B: Partial- and Non-responder - Low Dose to High Dose Part B: Partial- and Non-responder - High Dose to High Dose Part B: Placebo Extension
Hide Arm/Group Description:
Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
Baricitinib administered 8 mg or 10 mg PO QD.
Placebo PO QD maintained on placebo PO QD.
Overall Number of Participants Analyzed 29 64 19 16 50 43 8
Measure Type: Number
Unit of Measure: Percent of Participants
55.2 64.1 47.4 37.5 24.0 27.9 50.0
4.Secondary Outcome
Title Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])
Hide Description The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.
Time Frame Week 92
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.
Arm/Group Title Part D: Baricitinib 2 mg - Retreatment Part D: Baricitinib 4 mg - Retreatment Part D: Baricitinib 8 mg - Retreatment Part D: Baricitinib 10 mg - Retreatment
Hide Arm/Group Description:
Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Overall Number of Participants Analyzed 3 13 19 37
Measure Type: Number
Unit of Measure: Percent of Participants
33.3 23.1 21.1 27.0
5.Secondary Outcome
Title Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 12 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
Hide Description The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares Means (LS Means) were calculated using an analysis of covariance (ANCOVA) model on the last observation carried forward (LOCF) with treatment group as a fixed effect and baseline PASI score as a continuous covariate.
Time Frame Baseline Part A, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug. Missing values were imputed with the last observation carried forward (LOCF) method.
Arm/Group Title Part A: Placebo Part A: Baricitinib 2 mg Part A: Baricitinib 4 mg Part A: Baricitinib 8 mg Part A: Baricitinib 10 mg
Hide Arm/Group Description:
Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Overall Number of Participants Analyzed 34 32 72 64 69
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
5.14  (1.370) 9.40  (1.413) 9.46  (0.941) 11.52  (0.997) 13.93  (0.962)
6.Secondary Outcome
Title Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 24 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis: Measure: Psoriasis Area and Severity Index [PASI])
Hide Description The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
Time Frame Baseline Part A, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and at least 1 post-baseline observation in Part A at or prior to week 24. Missing values were imputed with the last observation carried forward (LOCF) method.
Arm/Group Title Part B: Responder - Low Dose Part B: Responder - High Dose Part B: Partial- and Non-responder - Placebo to High Dose Part B: Partial-responder - Low Dose to Low Dose Part B: Partial- and Non-responder - Low Dose to High Dose Part B: Partial- and Non-responder - High Dose to High Dose Part B: Placebo Extension
Hide Arm/Group Description:
Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
Baricitinib administered 8 mg or 10 mg PO QD.
Placebo PO QD maintained on placebo PO QD.
Overall Number of Participants Analyzed 29 64 19 16 50 43 8
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
15.62  (5.480) 16.69  (7.399) 12.94  (6.711) 12.23  (7.510) 14.55  (10.493) 13.67  (9.966) 13.43  (5.599)
7.Secondary Outcome
Title Change From Baseline in Part D in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 92 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
Hide Description The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
Time Frame Baseline Part D, Week 92
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug and has 1 post-baseline observation at or prior to week 92. Missing values were imputed with the last observation carried forward (LOCF) method.
Arm/Group Title Part D: Baricitinib 2 mg - Retreatment Part D: Baricitinib 4 mg - Retreatment Part D: Baricitinib 8 mg - Retreatment Part D: Baricitinib 10 mg - Retreatment
Hide Arm/Group Description:
Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Overall Number of Participants Analyzed 3 13 19 37
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
6.33  (2.836) 3.25  (4.447) 5.84  (5.544) 6.98  (6.456)
8.Secondary Outcome
Title Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12
Hide Description The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Time Frame Baseline Part A, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Arm/Group Title Part A: Placebo Part A: Baricitinib 2 mg Part A: Baricitinib 4 mg Part A: Baricitinib 8 mg Part A: Baricitinib 10 mg
Hide Arm/Group Description:
Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Overall Number of Participants Analyzed 34 32 72 63 68
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-1.7  (0.98) -3.4  (1.00) -4.6  (0.67) -4.0  (0.71) -5.1  (0.69)
9.Secondary Outcome
Title Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24
Hide Description The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant.
Time Frame Baseline Part A, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug in Part B and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Arm/Group Title Part B: Responder - Low Dose Part B: Responder - High Dose Part B: Partial- and Non-responder - Placebo to High Dose Part B: Partial-responder - Low Dose to Low Dose Part B: Partial- and Non-responder - Low Dose to High Dose Part B: Partial- and Non-responder - High Dose to High Dose Part B: Placebo Extension
Hide Arm/Group Description:
Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
Baricitinib administered 8 mg or 10 mg PO QD.
Placebo PO QD maintained on placebo PO QD.
Overall Number of Participants Analyzed 29 64 19 16 50 42 6
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-6.9  (7.53) -7.0  (8.18) -3.8  (6.27) -1.5  (5.92) -7.8  (6.89) -4.5  (8.99) -3.5  (11.76)
10.Secondary Outcome
Title Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92
Hide Description The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant.
Time Frame Baseline Part D, Week 92
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Arm/Group Title Part D: Baricitinib 2 mg - Retreatment Part D: Baricitinib 4 mg - Retreatment Part D: Baricitinib 8 mg - Retreatment Part D: Baricitinib 10 mg - Retreatment
Hide Arm/Group Description:
Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Overall Number of Participants Analyzed 3 13 18 37
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-3.3  (4.93) -0.5  (3.62) -2.1  (7.40) -5.0  (6.31)
11.Secondary Outcome
Title Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12
Hide Description The Itch NRS is a participant-administered, 11‑point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Time Frame Baseline Part A, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Arm/Group Title Part A: Placebo Part A: Baricitinib 2 mg Part A: Baricitinib 4 mg Part A: Baricitinib 8 mg Part A: Baricitinib 10 mg
Hide Arm/Group Description:
Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Overall Number of Participants Analyzed 34 32 72 64 69
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-1.1  (0.48) -2.8  (0.49) -3.3  (0.33) -3.8  (0.35) -4.7  (0.34)
12.Secondary Outcome
Title Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24
Hide Description The Itch NRS is a participant-administered, 11‑point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Time Frame Baseline Part A, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Arm/Group Title Part B: Responder - Low Dose Part B: Responder - High Dose Part B: Partial- and Non-responder - Placebo to High Dose Part B: Partial-responder - Low Dose to Low Dose Part B: Partial- and Non-responder - Low Dose to High Dose Part B: Partial- and Non-responder - High Dose to High Dose Part B: Placebo Extension
Hide Arm/Group Description:
Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
Baricitinib administered 8 mg or 10 mg PO QD.
Placebo PO QD maintained on placebo PO QD.
Overall Number of Participants Analyzed 29 64 19 16 49 43 8
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-4.7  (3.52) -5.6  (2.96) -5.4  (3.83) -3.4  (3.69) -4.1  (3.33) -3.5  (3.03) -2.5  (4.11)
13.Secondary Outcome
Title Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92
Hide Description The Itch NRS is a participant-administered, 11‑point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Time Frame Baseline Part D, Week 92
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Arm/Group Title Part D: Baricitinib 2 mg - Retreatment Part D: Baricitinib 4 mg - Retreatment Part D: Baricitinib 8 mg - Retreatment Part D: Baricitinib 10 mg - Retreatment
Hide Arm/Group Description:
Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Overall Number of Participants Analyzed 3 13 18 37
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-2.3  (0.58) -2.5  (3.23) -2.7  (2.91) -3.1  (3.38)
14.Secondary Outcome
Title Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score at Week 12
Hide Description The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Time Frame Baseline Part A, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Arm/Group Title Part A: Placebo Part A: Baricitinib 2 mg Part A: Baricitinib 4 mg Part A: Baricitinib 8 mg Part A: Baricitinib 10 mg
Hide Arm/Group Description:
Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Overall Number of Participants Analyzed 31 30 67 63 64
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-0.9  (0.57) -1.0  (0.58) -1.0  (0.39) -0.7  (0.40) -0.9  (0.40)
15.Secondary Outcome
Title Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24
Hide Description The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation.
Time Frame Baseline Part A, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. As observed values were used.
Arm/Group Title Part B: Responder - Low Dose Part B: Responder - High Dose Part B: Partial- and Non-responder - Placebo to High Dose Part B: Partial-responder - Low Dose to Low Dose Part B: Partial- and Non-responder - Low Dose to High Dose Part B: Partial- and Non-responder - High Dose to High Dose Part B: Placebo Extension
Hide Arm/Group Description:
Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
Baricitinib administered 8 mg or 10 mg PO QD.
Placebo PO QD maintained on placebo PO QD.
Overall Number of Participants Analyzed 26 57 19 14 41 38 5
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-1.6  (2.48) -2.6  (3.80) -1.4  (3.15) -1.2  (2.67) -1.6  (2.99) -2.2  (4.64) -3.0  (6.16)
16.Secondary Outcome
Title Change From Baseline Part D in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 92
Hide Description The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation.
Time Frame Baseline Part D, Week 92
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Arm/Group Title Part D: Baricitinib 2 mg - Retreatment Part D: Baricitinib 4 mg - Retreatment Part D: Baricitinib 8 mg - Retreatment Part D: Baricitinib 10 mg - Retreatment
Hide Arm/Group Description:
Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Overall Number of Participants Analyzed 0 4 8 14
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-0.25  (1.708) -0.13  (3.796) -0.86  (2.143)
17.Secondary Outcome
Title Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores
Hide Description The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the "worst health you can imagine" and 100 mm indicated the "best health you can imagine". This information is used as a quantitative measure of health outcome. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Time Frame Baseline Part A, Week 12
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Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. As observed values were used.
Arm/Group Title Part A: Placebo Part A: Baricitinib 2 mg Part A: Baricitinib 4 mg Part A: Baricitinib 8 mg Part A: Baricitinib 10 mg
Hide Arm/Group Description:
Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Overall Number of Participants Analyzed 27 29 67 60 62
Least Squares Mean (Standard Error)
Unit of Measure: Millimeter (mm)
2.9  (2.55) 5.7  (2.46) 6.4  (1.62) 9.5  (1.71) 7.8  (1.69)
18.Secondary Outcome
Title Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores
Hide Description The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the "worst health you can imagine" and 100 mm indicated the "best health you can imagine". This information is used as a quantitative measure of health outcome.
Time Frame Baseline Part A, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. As observed values were used.
Arm/Group Title Part B: Responder - Low Dose Part B: Responder - High Dose Part B: Partial- and Non-responder - Placebo to High Dose Part B: Partial-responder - Low Dose to Low Dose Part B: Partial- and Non-responder - Low Dose to High Dose Part B: Partial- and Non-responder - High Dose to High Dose Part B: Placebo Extension
Hide Arm/Group Description:
Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
Baricitinib administered 8 mg or 10 mg PO QD.
Placebo PO QD maintained on placebo PO QD.
Overall Number of Participants Analyzed 28 58 19 14 42 38 6
Mean (Standard Deviation)
Unit of Measure: mm
8.1  (11.41) 13.2  (22.06) 9.6  (10.78) 9.4  (20.95) 7.5  (14.47) 10.5  (19.94) 7.8  (11.92)
19.Secondary Outcome
Title Change From Baseline Part D in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores
Hide Description The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the "worst health you can imagine" and 100 mm indicated the "best health you can imagine". This information is used as a quantitative measure of health outcome.
Time Frame Baseline Part D, Week 92
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Arm/Group Title Part D: Baricitinib 2 mg - Retreatment Part D: Baricitinib 4 mg - Retreatment Part D: Baricitinib 8 mg - Retreatment Part D: Baricitinib 10 mg - Retreatment
Hide Arm/Group Description:
Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Overall Number of Participants Analyzed 3 13 18 37
Mean (Standard Deviation)
Unit of Measure: mm
8.67  (10.263) 4.00  (26.920) 4.78  (13.571) 4.19  (19.727)
20.Secondary Outcome
Title Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C
Hide Description Rebound was defined as worsening of psoriasis compared to baseline at Week 0 (for example, PASI score >125% of baseline value) or new pustular, erythrodermic, or more inflammatory psoriasis occurring within 3 months of stopping study drug.
Time Frame Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug in Part A and participated in Part C.
Arm/Group Title Part C: Responder - Low Dose to Placebo Part C: Responder - Low Dose to ½ Low Dose Part C: Responder - High Dose to Placebo Part C: Responder - High Dose to Low Dose
Hide Arm/Group Description:
Baricitinib 2 mg or 4 mg PO QD re-randomized to placebo PO QD.
Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 1 mg or 2 mg PO QD.
Baricitinib administered 8 mg or 10 mg PO QD re-randomized to placebo PO QD.
Baricitinib administered 8 mg PO QD re-randomized to baricitinib 4 mg PO QD. Baricitinib administered 10 mg PO QD re-randomized to baricitinib 4 mg PO QD.
Overall Number of Participants Analyzed 15 16 55 55
Measure Type: Number
Unit of Measure: Percentage of Participants
0 0 0 0
21.Secondary Outcome
Title Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib
Hide Description [Not Specified]
Time Frame Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug in Part A, had evaluable PK, and participated in Part C. Some participants received 4mg or 8 mg and increased to 8mg or 10 mg, depending on the response at week 12. Those participants are treated as separate participants in each dose group.
Arm/Group Title Baricitinib 2 mg Baricitinib 4 mg Baricitinib 8 mg Baricitinib 10 mg
Hide Arm/Group Description:
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Overall Number of Participants Analyzed 32 72 73 78
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanomole (nM)
52.4
(24.7%)
106
(25.9%)
222
(24.4%)
260
(22.9%)
22.Secondary Outcome
Title PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC τ,ss)
Hide Description [Not Specified]
Time Frame Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug in Part A, had evaluable PK, and participated in Part A, B or C. Some participants received 4mg or 8 mg and increased to 8mg or 10 mg, depending on the response at week 12. Those participants are treated as separate participants in each dose group.
Arm/Group Title Baricitinib 2 mg Baricitinib 4 mg Baricitinib 8 mg Baricitinib 10 mg
Hide Arm/Group Description:
Baricitinib 2 milligram (mg) administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Overall Number of Participants Analyzed 32 72 73 78
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanomole*hour (nM*h)
462
(40.7%)
975
(41.1%)
2030
(43.3%)
2440
(42.2%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part A: Placebo Part A: Baricitinib 2 mg Part A: Baricitinib 4 mg Part A: Baricitinib 8 mg Part A: Baricitinib 10 mg Part B: Placebo Part B: Low Dose Part B: High Dose Part C: Placebo Part C: Baricitinib Part D: All Baricitinib Doses Follow-up: Always Placebo Follow-up: Ever Used Baricitinib
Hide Arm/Group Description Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks. Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks. Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks. Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks. Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study. Placebo PO QD maintained on placebo PO QD.

All participants in the following groups (as described in the Participant Flow):

  • Responder Low Dose
  • Partial Responder Low Dose to Low Dose groups.

All participants in the following groups (as described in the Participant Flow):

  • Responder High Dose
  • Partial and Non-responder Placebo to High Dose
  • Partial and Non-responder Low Dose to High Dose
  • Partial and Non-responder High Dose to High Dose
All placebo participant groups after study drug re-randomized. All baricitinib participant groups after study drug re-randomized to various doses. All participant dosages following baricitinib retreatment with Part B efficacious dose for 52 weeks. Participants in follow-up with exposure to placebo only during the study. No placebo received during follow-up. Participants in follow-up with exposure to any dose of baricitinib during study. No baricitinib received during follow-up.
All-Cause Mortality
Part A: Placebo Part A: Baricitinib 2 mg Part A: Baricitinib 4 mg Part A: Baricitinib 8 mg Part A: Baricitinib 10 mg Part B: Placebo Part B: Low Dose Part B: High Dose Part C: Placebo Part C: Baricitinib Part D: All Baricitinib Doses Follow-up: Always Placebo Follow-up: Ever Used Baricitinib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Part A: Placebo Part A: Baricitinib 2 mg Part A: Baricitinib 4 mg Part A: Baricitinib 8 mg Part A: Baricitinib 10 mg Part B: Placebo Part B: Low Dose Part B: High Dose Part C: Placebo Part C: Baricitinib Part D: All Baricitinib Doses Follow-up: Always Placebo Follow-up: Ever Used Baricitinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/34 (2.94%)      1/32 (3.13%)      1/72 (1.39%)      1/64 (1.56%)      1/69 (1.45%)      0/8 (0.00%)      0/45 (0.00%)      2/176 (1.14%)      1/70 (1.43%)      1/71 (1.41%)      1/72 (1.39%)      0/8 (0.00%)      0/185 (0.00%)    
Cardiac disorders                           
Arteriosclerosis coronary artery  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 0/176 (0.00%)  0 0/70 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/8 (0.00%)  0 0/185 (0.00%)  0
Gastrointestinal disorders                           
Gastrointestinal haemorrhage  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 1/176 (0.57%)  1 0/70 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/8 (0.00%)  0 0/185 (0.00%)  0
Infections and infestations                           
Cellulitis  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 0/176 (0.00%)  0 1/70 (1.43%)  1 0/71 (0.00%)  0 0/72 (0.00%)  0 0/8 (0.00%)  0 0/185 (0.00%)  0
Pneumonia  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 1/69 (1.45%)  1 0/8 (0.00%)  0 0/45 (0.00%)  0 0/176 (0.00%)  0 0/70 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/8 (0.00%)  0 0/185 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                           
Oesophageal carcinoma  1  0/34 (0.00%)  0 0/32 (0.00%)  0 1/72 (1.39%)  1 0/64 (0.00%)  0 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 0/176 (0.00%)  0 0/70 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/8 (0.00%)  0 0/185 (0.00%)  0
Ovarian adenoma  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 0/176 (0.00%)  0 0/70 (0.00%)  0 1/17 (5.88%)  1 0/72 (0.00%)  0 0/8 (0.00%)  0 0/185 (0.00%)  0
Squamous cell carcinoma of skin  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 1/64 (1.56%)  1 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 0/176 (0.00%)  0 0/70 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/8 (0.00%)  0 0/185 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                           
Pulmonary embolism  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 1/176 (0.57%)  1 0/70 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/8 (0.00%)  0 0/185 (0.00%)  0
Skin and subcutaneous tissue disorders                           
Diabetic foot  1  1/34 (2.94%)  1 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 0/176 (0.00%)  0 0/70 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/8 (0.00%)  0 0/185 (0.00%)  0
Psoriasis  1  0/34 (0.00%)  0 1/32 (3.13%)  1 0/72 (0.00%)  0 0/64 (0.00%)  0 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 0/176 (0.00%)  0 0/70 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/8 (0.00%)  0 0/185 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Part A: Placebo Part A: Baricitinib 2 mg Part A: Baricitinib 4 mg Part A: Baricitinib 8 mg Part A: Baricitinib 10 mg Part B: Placebo Part B: Low Dose Part B: High Dose Part C: Placebo Part C: Baricitinib Part D: All Baricitinib Doses Follow-up: Always Placebo Follow-up: Ever Used Baricitinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/34 (32.35%)      9/32 (28.13%)      12/72 (16.67%)      21/64 (32.81%)      23/69 (33.33%)      4/8 (50.00%)      13/45 (28.89%)      41/176 (23.30%)      11/70 (15.71%)      16/71 (22.54%)      37/72 (51.39%)      0/8 (0.00%)      8/185 (4.32%)    
Blood and lymphatic system disorders                           
Lymphopenia  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 3/64 (4.69%)  4 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 0/176 (0.00%)  0 1/70 (1.43%)  1 0/71 (0.00%)  0 2/72 (2.78%)  2 0/8 (0.00%)  0 0/185 (0.00%)  0
Neutropenia  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 3/69 (4.35%)  3 0/8 (0.00%)  0 0/45 (0.00%)  0 2/176 (1.14%)  2 0/70 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/8 (0.00%)  0 0/185 (0.00%)  0
Gastrointestinal disorders                           
Abdominal discomfort  1  1/34 (2.94%)  1 2/32 (6.25%)  2 0/72 (0.00%)  0 2/64 (3.13%)  2 2/69 (2.90%)  2 0/8 (0.00%)  0 0/45 (0.00%)  0 0/176 (0.00%)  0 0/70 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/8 (0.00%)  0 0/185 (0.00%)  0
Gastric ulcer  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 0/69 (0.00%)  0 1/8 (12.50%)  1 0/45 (0.00%)  0 0/176 (0.00%)  0 0/70 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/8 (0.00%)  0 0/185 (0.00%)  0
General disorders                           
Fatigue  1  1/34 (2.94%)  1 2/32 (6.25%)  2 0/72 (0.00%)  0 1/64 (1.56%)  1 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 1/176 (0.57%)  1 0/70 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/8 (0.00%)  0 0/185 (0.00%)  0
Infections and infestations                           
Herpes zoster  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 1/64 (1.56%)  1 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 1/176 (0.57%)  1 0/70 (0.00%)  0 1/71 (1.41%)  1 3/72 (4.17%)  3 0/8 (0.00%)  0 0/185 (0.00%)  0
Influenza  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 3/176 (1.70%)  3 1/70 (1.43%)  1 3/71 (4.23%)  3 3/72 (4.17%)  3 0/8 (0.00%)  0 0/185 (0.00%)  0
Nasopharyngitis  1  4/34 (11.76%)  7 1/32 (3.13%)  1 2/72 (2.78%)  2 6/64 (9.38%)  7 6/69 (8.70%)  6 0/8 (0.00%)  0 5/45 (11.11%)  5 9/176 (5.11%)  10 3/70 (4.29%)  4 6/71 (8.45%)  6 12/72 (16.67%)  14 0/8 (0.00%)  0 2/185 (1.08%)  2
Sinusitis  1  1/34 (2.94%)  1 1/32 (3.13%)  1 1/72 (1.39%)  1 0/64 (0.00%)  0 1/69 (1.45%)  1 0/8 (0.00%)  0 1/45 (2.22%)  1 3/176 (1.70%)  4 1/70 (1.43%)  1 0/71 (0.00%)  0 3/72 (4.17%)  3 0/8 (0.00%)  0 1/185 (0.54%)  1
Upper respiratory tract infection  1  1/34 (2.94%)  1 1/32 (3.13%)  1 0/72 (0.00%)  0 1/64 (1.56%)  1 2/69 (2.90%)  2 0/8 (0.00%)  0 2/45 (4.44%)  3 5/176 (2.84%)  5 0/70 (0.00%)  0 1/71 (1.41%)  1 7/72 (9.72%)  10 0/8 (0.00%)  0 1/185 (0.54%)  1
Urinary tract infection  1  1/34 (2.94%)  1 1/32 (3.13%)  1 3/72 (4.17%)  3 1/64 (1.56%)  1 2/69 (2.90%)  2 0/8 (0.00%)  0 0/45 (0.00%)  0 4/176 (2.27%)  4 1/70 (1.43%)  1 2/71 (2.82%)  2 2/72 (2.78%)  2 0/8 (0.00%)  0 2/185 (1.08%)  2
Vulvovaginal mycotic infection  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 0/176 (0.00%)  0 0/70 (0.00%)  0 0/71 (0.00%)  0 1/16 (6.25%)  1 0/8 (0.00%)  0 0/185 (0.00%)  0
Injury, poisoning and procedural complications                           
Limb injury  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 3/69 (4.35%)  3 0/8 (0.00%)  0 0/45 (0.00%)  0 3/176 (1.70%)  3 0/70 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/8 (0.00%)  0 0/185 (0.00%)  0
Muscle strain  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 1/64 (1.56%)  1 0/69 (0.00%)  0 1/8 (12.50%)  1 0/45 (0.00%)  0 2/176 (1.14%)  2 0/70 (0.00%)  0 0/71 (0.00%)  0 2/72 (2.78%)  3 0/8 (0.00%)  0 0/185 (0.00%)  0
Investigations                           
Blood creatine phosphokinase increased  1  0/34 (0.00%)  0 2/32 (6.25%)  2 1/72 (1.39%)  1 3/64 (4.69%)  3 5/69 (7.25%)  5 0/8 (0.00%)  0 0/45 (0.00%)  0 1/176 (0.57%)  1 0/70 (0.00%)  0 1/71 (1.41%)  1 3/72 (4.17%)  3 0/8 (0.00%)  0 1/185 (0.54%)  1
Musculoskeletal and connective tissue disorders                           
Arthralgia  1  2/34 (5.88%)  2 0/32 (0.00%)  0 1/72 (1.39%)  1 1/64 (1.56%)  1 2/69 (2.90%)  2 0/8 (0.00%)  0 0/45 (0.00%)  0 0/176 (0.00%)  0 1/70 (1.43%)  1 0/71 (0.00%)  0 2/72 (2.78%)  2 0/8 (0.00%)  0 0/185 (0.00%)  0
Back pain  1  2/34 (5.88%)  2 1/32 (3.13%)  1 2/72 (2.78%)  2 1/64 (1.56%)  1 2/69 (2.90%)  2 0/8 (0.00%)  0 0/45 (0.00%)  0 2/176 (1.14%)  2 1/70 (1.43%)  1 1/71 (1.41%)  1 3/72 (4.17%)  3 0/8 (0.00%)  0 0/185 (0.00%)  0
Joint swelling  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 1/69 (1.45%)  1 1/8 (12.50%)  1 0/45 (0.00%)  0 0/176 (0.00%)  0 0/70 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/8 (0.00%)  0 0/185 (0.00%)  0
Nervous system disorders                           
Headache  1  2/34 (5.88%)  2 0/32 (0.00%)  0 3/72 (4.17%)  3 5/64 (7.81%)  5 1/69 (1.45%)  1 1/8 (12.50%)  1 3/45 (6.67%)  3 7/176 (3.98%)  7 1/70 (1.43%)  1 1/71 (1.41%)  2 1/72 (1.39%)  2 0/8 (0.00%)  0 0/185 (0.00%)  0
Pregnancy, puerperium and perinatal conditions                           
Pregnancy  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 0/69 (0.00%)  0 0/8 (0.00%)  0 1/13 (7.69%)  1 0/176 (0.00%)  0 0/70 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/8 (0.00%)  0 0/185 (0.00%)  0
Reproductive system and breast disorders                           
Menopausal symptoms  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 0/176 (0.00%)  0 0/70 (0.00%)  0 0/71 (0.00%)  0 1/16 (6.25%)  1 0/8 (0.00%)  0 0/185 (0.00%)  0
Ovarian cyst  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 0/176 (0.00%)  0 1/19 (5.26%)  1 0/71 (0.00%)  0 0/72 (0.00%)  0 0/8 (0.00%)  0 0/185 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                           
Cough  1  0/34 (0.00%)  0 0/32 (0.00%)  0 1/72 (1.39%)  1 0/64 (0.00%)  0 1/69 (1.45%)  1 0/8 (0.00%)  0 1/45 (2.22%)  1 2/176 (1.14%)  2 2/70 (2.86%)  2 0/71 (0.00%)  0 3/72 (4.17%)  3 0/8 (0.00%)  0 1/185 (0.54%)  1
Oropharyngeal pain  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 1/69 (1.45%)  1 0/8 (0.00%)  0 0/45 (0.00%)  0 2/176 (1.14%)  2 0/70 (0.00%)  0 0/71 (0.00%)  0 3/72 (4.17%)  3 0/8 (0.00%)  0 0/185 (0.00%)  0
Surgical and medical procedures                           
Hysterectomy  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 0/176 (0.00%)  0 0/70 (0.00%)  0 0/71 (0.00%)  0 1/16 (6.25%)  1 0/8 (0.00%)  0 0/185 (0.00%)  0
Salpingo-oophorectomy bilateral  1  0/34 (0.00%)  0 0/32 (0.00%)  0 0/72 (0.00%)  0 0/64 (0.00%)  0 0/69 (0.00%)  0 0/8 (0.00%)  0 0/45 (0.00%)  0 0/176 (0.00%)  0 0/70 (0.00%)  0 0/71 (0.00%)  0 1/16 (6.25%)  1 0/8 (0.00%)  0 0/185 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01490632     History of Changes
Other Study ID Numbers: 14455
I4V-MC-JADP ( Other Identifier: Eli Lilly and Company )
First Submitted: December 9, 2011
First Posted: December 13, 2011
Results First Submitted: March 10, 2017
Results First Posted: July 18, 2017
Last Update Posted: September 27, 2019