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Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis

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: NCT02969018
Recruitment Status : Completed
First Posted : November 21, 2016
Results First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Plaque Psoriasis
Interventions Drug: PF-06700841
Other: Placebo
Enrollment 212
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Hide Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
Period Title: Overall Study
Started 25 29 26 25 29 25 30 23
Completed 21 21 20 20 27 17 22 16
Not Completed 4 8 6 5 2 8 8 7
Reason Not Completed
Adverse Event             2             4             1             2             0             1             2             0
Lack of Efficacy             0             1             0             0             1             1             1             1
Lost to Follow-up             1             2             2             0             1             1             0             1
No Longer Meets Eligibility Criteria             0             0             0             0             0             0             1             0
Non-Compliance With Study Drug             1             0             0             0             0             0             0             0
Other             0             0             0             1             0             0             0             2
Pregnancy             0             0             0             0             0             1             0             0
Protocol Violation             0             0             1             1             0             0             0             0
Withdrawal by Subject             0             1             2             1             0             4             4             3
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo Total
Hide Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets. Total of all reporting groups
Overall Number of Baseline Participants 25 29 26 25 29 25 30 23 212
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of PF-06700841 or placebo.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 29 participants 26 participants 25 participants 29 participants 25 participants 30 participants 23 participants 212 participants
49.0  (14.69) 44.6  (13.71) 45.5  (12.93) 48.4  (15.47) 44.2  (10.92) 44.0  (11.56) 43.2  (12.28) 50.3  (12.23) 46.0  (13.04)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 29 participants 26 participants 25 participants 29 participants 25 participants 30 participants 23 participants 212 participants
18-44 Years
8
  32.0%
14
  48.3%
10
  38.5%
8
  32.0%
14
  48.3%
12
  48.0%
14
  46.7%
8
  34.8%
88
  41.5%
45-64 Years
14
  56.0%
13
  44.8%
14
  53.8%
13
  52.0%
14
  48.3%
13
  52.0%
16
  53.3%
12
  52.2%
109
  51.4%
>=65 Years
3
  12.0%
2
   6.9%
2
   7.7%
4
  16.0%
1
   3.4%
0
   0.0%
0
   0.0%
3
  13.0%
15
   7.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 29 participants 26 participants 25 participants 29 participants 25 participants 30 participants 23 participants 212 participants
Female
9
  36.0%
8
  27.6%
14
  53.8%
4
  16.0%
10
  34.5%
8
  32.0%
7
  23.3%
4
  17.4%
64
  30.2%
Male
16
  64.0%
21
  72.4%
12
  46.2%
21
  84.0%
19
  65.5%
17
  68.0%
23
  76.7%
19
  82.6%
148
  69.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 29 participants 26 participants 25 participants 29 participants 25 participants 30 participants 23 participants 212 participants
Hispanic or Latino
4
  16.0%
4
  13.8%
4
  15.4%
2
   8.0%
6
  20.7%
5
  20.0%
4
  13.3%
4
  17.4%
33
  15.6%
Not Hispanic or Latino
21
  84.0%
25
  86.2%
22
  84.6%
23
  92.0%
23
  79.3%
20
  80.0%
26
  86.7%
19
  82.6%
179
  84.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
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 25 participants 29 participants 26 participants 25 participants 29 participants 25 participants 30 participants 23 participants 212 participants
White
22
  88.0%
27
  93.1%
23
  88.5%
24
  96.0%
27
  93.1%
22
  88.0%
25
  83.3%
19
  82.6%
189
  89.2%
Black or African American
3
  12.0%
0
   0.0%
3
  11.5%
0
   0.0%
1
   3.4%
1
   4.0%
1
   3.3%
2
   8.7%
11
   5.2%
Asian
0
   0.0%
1
   3.4%
0
   0.0%
1
   4.0%
0
   0.0%
0
   0.0%
2
   6.7%
0
   0.0%
4
   1.9%
American Indian or Alaska Native
0
   0.0%
1
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
1
   4.3%
3
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
1
   3.3%
0
   0.0%
2
   0.9%
Other
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.4%
0
   0.0%
1
   3.3%
1
   4.3%
3
   1.4%
1.Primary Outcome
Title Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
Hide Description The PASI quantifies the severity of a participant’s psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. In each area, the sum of the severity rating scores for erythema, induration and scaling is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the four body areas is the PASI. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame Baseline (Day 1 pre-dose), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data for Week 12.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Hide Arm/Group Description:
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 12 weeks of blinded matching placebo QD tablets.
Overall Number of Participants Analyzed 22 21 21 21 27 19 25 17
Least Squares Mean (90% Confidence Interval)
Unit of Measure: units on a scale
-15.85
(-18.31 to -13.39)
-10.56
(-12.96 to -8.16)
-14.28
(-16.75 to -11.81)
-10.14
(-12.62 to -7.66)
-17.28
(-19.55 to -15.02)
-13.27
(-15.78 to -10.76)
-11.88
(-14.16 to -9.59)
-7.21
(-9.96 to -4.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments Hochberg adjusted p-value
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -8.64
Confidence Interval (2-Sided) 90%
-12.33 to -4.95
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.232
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg QD Followed by 10 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0963
Comments Hochberg adjusted p-value
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.34
Confidence Interval (2-Sided) 90%
-6.99 to 0.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.206
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0046
Comments Hochberg adjusted p-value
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -7.07
Confidence Interval (2-Sided) 90%
-10.76 to -3.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.233
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg QD Followed by Placebo, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0963
Comments Hochberg adjusted p-value
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.93
Confidence Interval (2-Sided) 90%
-6.63 to 0.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.238
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-06700841 30 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Hochberg adjusted p-value
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -10.07
Confidence Interval (2-Sided) 90%
-13.63 to -6.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.152
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-06700841 30 mg QD Followed by 10 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0158
Comments Hochberg adjusted p-value
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -6.06
Confidence Interval (2-Sided) 90%
-9.79 to -2.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.255
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-06700841 30 mg QD Followed by 100 mg QW, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0488
Comments Hochberg adjusted p-value
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -4.66
Confidence Interval (2-Sided) 90%
-8.24 to -1.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.163
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12
Hide Description A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data at Week 12 after non-responder imputation applied.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Hide Arm/Group Description:
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 12 weeks of blinded matching placebo QD tablets.
Overall Number of Participants Analyzed 25 29 26 25 29 25 30 23
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
60.0
(41.68 to 76.44)
24.1
(11.92 to 40.60)
57.7
(39.84 to 74.16)
24.0
(11.01 to 41.95)
86.2
(71.16 to 95.15)
24.0
(11.01 to 41.95)
36.7
(22.11 to 53.31)
13.0
(3.65 to 30.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 10.00
Confidence Interval (2-Sided) 90%
2.95 to 33.87
Estimation Comments [Not Specified]
Other Statistical Analysis Logistic regression
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg QD Followed by 10 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.12
Confidence Interval (2-Sided) 90%
0.61 to 7.36
Estimation Comments [Not Specified]
Other Statistical Analysis Logistic regression
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.09
Confidence Interval (2-Sided) 90%
2.71 to 30.48
Estimation Comments [Not Specified]
Other Statistical Analysis Logistic regression
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg QD Followed by Placebo, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.11
Confidence Interval (2-Sided) 90%
0.59 to 7.55
Estimation Comments [Not Specified]
Other Statistical Analysis Logistic regression
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-06700841 30 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 41.67
Confidence Interval (2-Sided) 90%
10.80 to 160.68
Estimation Comments [Not Specified]
Other Statistical Analysis Logistic regression
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-06700841 30 mg QD Followed by 10 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.11
Confidence Interval (2-Sided) 90%
0.59 to 7.55
Estimation Comments [Not Specified]
Other Statistical Analysis Logistic regression
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-06700841 30 mg QD Followed by 100 mg QW, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.86
Confidence Interval (2-Sided) 90%
1.17 to 12.74
Estimation Comments [Not Specified]
Other Statistical Analysis Logistic regression
3.Secondary Outcome
Title Change From Baseline in PASI Scores at Week 4 by Induction Dose
Hide Description Change from baseline in PASI scores at Week 4 was presented by induction dose (ie, PF-06700841 60 mg QD, 30 mg QD, and placebo). The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame Baseline (Day 1 pre-dose), Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data at Week 4.
Arm/Group Title PF-06700841 60 mg QD as the Induction Dose PF-06700841 30 mg QD as the Induction Dose Placebo as the Induction Dose
Hide Arm/Group Description:
Participants received PF-06700841 60 mg QD as the induction dose.
Participants received PF-06700841 30 mg QD as the induction dose.
Participants received matching placebo QD as the induction dose.
Overall Number of Participants Analyzed 100 81 21
Least Squares Mean (90% Confidence Interval)
Unit of Measure: units on a scale
-13.17
(-14.20 to -12.15)
-12.16
(-13.31 to -11.02)
-4.17
(-6.38 to -1.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06700841 60 mg QD as the Induction Dose, Placebo as the Induction Dose
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -9.00
Confidence Interval (2-Sided) 90%
-11.43 to -6.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.470
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-06700841 30 mg QD as the Induction Dose, Placebo as the Induction Dose
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -7.99
Confidence Interval (2-Sided) 90%
-10.48 to -5.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.502
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16
Hide Description A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame Weeks 1, 2, 4, 6, 8, 10, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data for each specified time point after non-responder imputation applied.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Hide Arm/Group Description:
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 12 weeks of blinded matching placebo QD tablets.
Overall Number of Participants Analyzed 25 29 26 25 29 25 30 23
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 1
0
(0.00 to 11.29)
6.9
(1.24 to 20.16)
7.7
(1.38 to 22.29)
4.0
(0.20 to 17.61)
0
(0.00 to 9.81)
4.0
(0.20 to 17.61)
0
(0.00 to 9.50)
0
(0.00 to 12.21)
Week 2
8.0
(1.44 to 23.10)
13.8
(4.85 to 28.84)
26.9
(13.38 to 44.68)
12.0
(3.35 to 28.17)
3.4
(0.18 to 15.34)
8.0
(1.44 to 23.10)
0
(0.00 to 9.50)
0
(0.00 to 12.21)
Week 4
24.0
(11.01 to 41.95)
41.4
(25.89 to 58.25)
61.5
(43.57 to 77.43)
36.0
(20.24 to 54.39)
27.6
(14.53 to 44.29)
24.0
(11.01 to 41.95)
36.7
(22.11 to 53.31)
0
(0.00 to 12.21)
Week 6
44.0
(26.99 to 62.14)
41.4
(25.89 to 58.25)
65.4
(47.38 to 80.60)
36.0
(20.24 to 54.39)
51.7
(35.20 to 67.97)
28.0
(13.95 to 46.22)
26.7
(14.02 to 42.99)
8.7
(1.57 to 24.92)
Week 8
60.0
(41.68 to 76.44)
37.9
(22.93 to 54.88)
65.4
(47.38 to 80.60)
32.0
(17.03 to 50.36)
65.5
(48.57 to 79.95)
20.0
(8.23 to 37.54)
40.0
(24.95 to 56.61)
8.7
(1.57 to 24.92)
Week 10
48.0
(30.51 to 65.86)
24.1
(11.92 to 40.60)
61.5
(43.57 to 77.43)
32.0
(17.03 to 50.36)
72.4
(55.71 to 85.47)
28.0
(13.95 to 46.22)
46.7
(30.85 to 63.01)
13.0
(3.65 to 30.36)
Week 14
48.0
(30.51 to 65.86)
17.2
(7.05 to 32.89)
34.6
(19.40 to 52.62)
16.0
(5.66 to 32.96)
75.9
(59.40 to 88.08)
16.0
(5.66 to 32.96)
16.7
(6.81 to 31.90)
8.7
(1.57 to 24.92)
Week 16
36.0
(20.24 to 54.39)
10.3
(2.88 to 24.61)
30.8
(16.33 to 48.70)
20.0
(8.23 to 37.54)
58.6
(41.75 to 74.11)
12.0
(3.35 to 28.17)
16.7
(6.81 to 31.90)
8.7
(1.57 to 24.92)
5.Secondary Outcome
Title Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Hide Description A PASI50 response is a 50% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data for each specified time point after non-responder imputation applied.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Hide Arm/Group Description:
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 12 weeks of blinded matching placebo QD tablets.
Overall Number of Participants Analyzed 25 29 26 25 29 25 30 23
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 1
12.0
(3.35 to 28.17)
13.8
(4.85 to 28.84)
19.2
(7.90 to 36.26)
20.0
(8.23 to 37.54)
10.3
(2.88 to 24.61)
8.0
(1.44 to 23.10)
3.3
(0.17 to 14.86)
0
(0.00 to 12.21)
Week 2
44.0
(26.99 to 62.14)
37.9
(22.93 to 54.88)
46.2
(29.21 to 63.79)
32.0
(17.03 to 50.36)
41.4
(25.89 to 58.25)
20.0
(8.23 to 37.54)
33.3
(19.33 to 49.94)
0
(0.00 to 12.21)
Week 4
60.0
(41.68 to 76.44)
69.0
(52.10 to 82.75)
69.2
(51.30 to 83.67)
68.0
(49.64 to 82.97)
69.0
(52.10 to 82.75)
60.0
(41.68 to 76.44)
66.7
(50.06 to 80.67)
13.0
(3.65 to 30.36)
Week 6
72.0
(53.78 to 86.05)
62.1
(45.12 to 77.07)
73.1
(55.32 to 86.62)
68.0
(49.64 to 82.97)
82.8
(67.11 to 92.95)
60.0
(41.68 to 76.44)
63.3
(46.69 to 77.89)
26.1
(12.02 to 45.10)
Week 8
72.0
(53.78 to 86.05)
55.2
(38.44 to 71.07)
73.1
(55.32 to 86.62)
52.0
(34.14 to 69.49)
86.2
(71.16 to 95.15)
56.0
(37.86 to 73.01)
63.3
(46.69 to 77.89)
17.4
(6.17 to 35.49)
Week 10
68.0
(49.64 to 82.97)
44.8
(28.93 to 61.56)
73.1
(55.32 to 86.62)
48.0
(30.51 to 65.86)
86.2
(71.16 to 95.15)
48.0
(30.51 to 65.86)
56.7
(40.16 to 72.13)
17.4
(6.17 to 35.49)
Week 12
68.0
(49.64 to 82.97)
44.8
(28.93 to 61.56)
69.2
(51.30 to 83.67)
52.0
(34.14 to 69.49)
89.7
(75.39 to 97.12)
48.0
(30.51 to 65.86)
53.3
(36.99 to 69.15)
21.7
(8.98 to 40.39)
Week 14
64.0
(45.61 to 79.76)
44.8
(28.93 to 61.56)
61.5
(43.57 to 77.43)
48.0
(30.51 to 65.86)
89.7
(75.39 to 97.12)
36.0
(20.24 to 54.39)
36.7
(22.11 to 53.31)
26.1
(12.02 to 45.10)
Week 16
60.0
(41.68 to 76.44)
34.5
(20.05 to 51.43)
53.8
(36.21 to 70.79)
40.0
(23.56 to 58.32)
79.3
(63.20 to 90.58)
40.0
(23.56 to 58.32)
36.7
(22.11 to 53.31)
21.7
(8.98 to 40.39)
6.Secondary Outcome
Title Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Hide Description A PASI90 response is a 90% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data for each specified time point after non-responder imputation applied.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Hide Arm/Group Description:
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 12 weeks of blinded matching placebo QD tablets.
Overall Number of Participants Analyzed 25 29 26 25 29 25 30 23
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 1
0
(0.00 to 11.29)
3.4
(0.18 to 15.34)
0
(0.00 to 10.88)
0
(0.00 to 11.29)
0
(0.00 to 9.81)
0
(0.00 to 11.29)
0
(0.00 to 9.50)
0
(0.00 to 12.21)
Week 2
0
(0.00 to 11.29)
3.4
(0.18 to 15.34)
7.7
(1.38 to 22.29)
0
(0.00 to 11.29)
0
(0.00 to 9.81)
0
(0.00 to 11.29)
0
(0.00 to 9.50)
0
(0.00 to 12.21)
Week 4
12.0
(3.35 to 28.17)
20.7
(9.42 to 36.80)
42.3
(25.84 to 60.16)
16.0
(5.66 to 32.96)
6.9
(1.24 to 20.16)
8.0
(1.44 to 23.10)
3.3
(0.17 to 14.86)
0
(0.00 to 12.21)
Week 6
16.0
(5.66 to 32.96)
20.7
(9.42 to 36.80)
26.9
(13.38 to 44.68)
12.0
(3.35 to 28.17)
24.1
(11.92 to 40.60)
8.0
(1.44 to 23.10)
20.0
(9.09 to 35.70)
0
(0.00 to 12.21)
Week 8
24.0
(11.01 to 41.95)
17.2
(7.05 to 32.89)
30.8
(16.33 to 48.70)
8.0
(1.44 to 23.10)
34.5
(20.05 to 51.43)
4.0
(0.20 to 17.61)
16.7
(6.81 to 31.90)
0
(0.00 to 12.21)
Week 10
28.0
(13.95 to 46.22)
17.2
(7.05 to 32.89)
26.9
(13.38 to 44.68)
8.0
(1.44 to 23.10)
34.5
(20.05 to 51.43)
8.0
(1.44 to 23.10)
13.3
(4.69 to 27.96)
4.3
(0.22 to 19.02)
Week 12
36.0
(20.24 to 54.39)
13.8
(4.85 to 28.84)
26.9
(13.38 to 44.68)
8.0
(1.44 to 23.10)
51.7
(35.20 to 67.97)
8.0
(1.44 to 23.10)
10.0
(2.78 to 23.86)
4.3
(0.22 to 19.02)
Week 14
28.0
(13.95 to 46.22)
13.8
(4.85 to 28.84)
11.5
(3.22 to 27.19)
8.0
(1.44 to 23.10)
37.9
(22.93 to 54.88)
4.0
(0.20 to 17.61)
13.3
(4.69 to 27.96)
4.3
(0.22 to 19.02)
Week 16
20.0
(8.23 to 37.54)
3.4
(0.18 to 15.34)
15.4
(5.43 to 31.82)
4.0
(0.20 to 17.61)
27.6
(14.53 to 44.29)
8.0
(1.44 to 23.10)
10.0
(2.78 to 23.86)
4.3
(0.22 to 19.02)
7.Secondary Outcome
Title Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16
Hide Description The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
”Number of participants analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo). ”Number analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data for each specified time point.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Hide Arm/Group Description:
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 12 weeks of blinded matching placebo QD tablets.
Overall Number of Participants Analyzed 25 29 26 25 29 25 30 23
Mean (90% Confidence Interval)
Unit of Measure: units on a scale
Week 1 Number Analyzed 25 participants 29 participants 24 participants 25 participants 28 participants 25 participants 30 participants 23 participants
-5.74
(-7.61 to -3.86)
-4.60
(-6.06 to -3.14)
-5.85
(-7.62 to -4.08)
-5.37
(-7.59 to -3.15)
-3.97
(-5.00 to -2.95)
-4.41
(-6.18 to -2.64)
-3.46
(-4.64 to -2.28)
-1.35
(-2.03 to -0.66)
Week 2 Number Analyzed 24 participants 28 participants 24 participants 24 participants 28 participants 25 participants 30 participants 21 participants
-9.44
(-11.74 to -7.15)
-8.35
(-10.07 to -6.63)
-10.79
(-13.05 to -8.52)
-9.49
(-12.40 to -6.58)
-7.86
(-9.38 to -6.35)
-7.79
(-9.79 to -5.79)
-7.93
(-9.64 to -6.22)
-2.28
(-3.21 to -1.36)
Week 4 Number Analyzed 23 participants 28 participants 25 participants 24 participants 28 participants 25 participants 28 participants 21 participants
-12.85
(-15.76 to -9.94)
-12.19
(-14.57 to -9.81)
-14.11
(-16.37 to -11.86)
-13.91
(-16.98 to -10.85)
-11.72
(-13.61 to -9.83)
-12.88
(-15.49 to -10.27)
-13.06
(-15.58 to -10.53)
-4.02
(-6.04 to -2.00)
Week 6 Number Analyzed 23 participants 25 participants 24 participants 23 participants 28 participants 24 participants 27 participants 19 participants
-15.00
(-18.30 to -11.71)
-12.12
(-14.53 to -9.71)
-15.00
(-17.35 to -12.66)
-13.85
(-16.62 to -11.08)
-14.30
(-16.24 to -12.36)
-14.33
(-17.47 to -11.19)
-14.17
(-16.92 to -11.41)
-5.52
(-7.58 to -3.45)
Week 8 Number Analyzed 23 participants 24 participants 22 participants 22 participants 27 participants 21 participants 27 participants 17 participants
-15.94
(-19.40 to -12.49)
-11.09
(-12.90 to -9.27)
-14.97
(-17.66 to -12.27)
-12.87
(-15.69 to -10.04)
-15.82
(-17.81 to -13.84)
-14.27
(-17.51 to -11.03)
-13.83
(-16.79 to -10.87)
-6.56
(-8.61 to -4.51)
Week 10 Number Analyzed 21 participants 22 participants 22 participants 23 participants 26 participants 21 participants 27 participants 17 participants
-16.54
(-20.54 to -12.54)
-9.89
(-12.16 to -7.61)
-15.52
(-18.09 to -12.96)
-11.64
(-14.92 to -8.37)
-16.65
(-18.64 to -14.66)
-14.98
(-18.43 to -11.53)
-12.97
(-16.19 to -9.74)
-6.78
(-9.20 to -4.37)
Week 14 Number Analyzed 21 participants 21 participants 21 participants 22 participants 27 participants 19 participants 24 participants 16 participants
-15.47
(-19.88 to -11.06)
-8.11
(-10.69 to -5.53)
-13.31
(-16.73 to -9.89)
-9.45
(-12.96 to -5.94)
-16.14
(-18.16 to -14.12)
-10.44
(-13.33 to -7.55)
-11.03
(-14.61 to -7.44)
-6.98
(-9.81 to -4.14)
Week 16 Number Analyzed 21 participants 21 participants 20 participants 21 participants 26 participants 18 participants 23 participants 16 participants
-14.16
(-18.68 to -9.64)
-6.59
(-9.09 to -4.09)
-13.00
(-16.60 to -9.40)
-7.83
(-11.56 to -4.11)
-14.38
(-16.74 to -12.01)
-9.62
(-13.08 to -6.16)
-9.13
(-13.94 to -4.33)
-6.76
(-9.80 to -3.72)
8.Secondary Outcome
Title Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Hide Description The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
”Number of participants analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo). ”Number analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data for each specified time point.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Hide Arm/Group Description:
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 12 weeks of blinded matching placebo QD tablets.
Overall Number of Participants Analyzed 25 29 26 25 29 25 30 23
Mean (90% Confidence Interval)
Unit of Measure: percent change
Week 1 Number Analyzed 25 participants 29 participants 24 participants 25 participants 28 participants 25 participants 30 participants 23 participants
-26.70
(-33.80 to -19.60)
-24.66
(-33.24 to -16.08)
-30.25
(-39.07 to -21.44)
-23.33
(-30.84 to -15.82)
-20.92
(-26.82 to -15.01)
-17.50
(-23.91 to -11.10)
-15.42
(-20.68 to -10.16)
-6.90
(-10.50 to -3.30)
Week 2 Number Analyzed 24 participants 28 participants 24 participants 24 participants 28 participants 25 participants 30 participants 21 participants
-43.66
(-52.81 to -34.52)
-44.17
(-52.75 to -35.59)
-54.27
(-64.17 to -44.36)
-42.58
(-51.17 to -33.98)
-40.89
(-47.94 to -33.83)
-32.46
(-39.75 to -25.16)
-35.89
(-42.69 to -29.09)
-12.81
(-18.29 to -7.33)
Week 4 Number Analyzed 23 participants 28 participants 25 participants 24 participants 28 participants 25 participants 28 participants 21 participants
-57.16
(-67.35 to -46.97)
-63.02
(-72.12 to -53.91)
-72.41
(-82.31 to -62.51)
-64.71
(-72.81 to -56.61)
-60.76
(-68.38 to -53.14)
-53.93
(-62.59 to -45.28)
-58.99
(-67.94 to -50.03)
-25.17
(-34.24 to -16.09)
Week 6 Number Analyzed 23 participants 25 participants 24 participants 23 participants 28 participants 24 participants 27 participants 19 participants
-66.07
(-76.06 to -56.08)
-63.31
(-73.99 to -52.62)
-75.96
(-84.68 to -67.25)
-65.06
(-74.15 to -55.97)
-73.91
(-80.62 to -67.19)
-58.57
(-66.76 to -50.37)
-63.17
(-72.37 to -53.96)
-33.49
(-44.16 to -22.83)
Week 8 Number Analyzed 23 participants 24 participants 22 participants 22 participants 27 participants 21 participants 27 participants 17 participants
-70.11
(-80.95 to -59.27)
-62.25
(-72.42 to -52.07)
-77.05
(-86.69 to -67.41)
-59.88
(-69.78 to -49.97)
-81.04
(-86.69 to -75.40)
-58.32
(-66.39 to -50.25)
-61.38
(-71.80 to -50.96)
-37.76
(-47.73 to -27.80)
Week 10 Number Analyzed 21 participants 22 participants 22 participants 23 participants 26 participants 21 participants 27 participants 17 participants
-70.72
(-83.32 to -58.12)
-57.55
(-69.11 to -46.00)
-78.46
(-85.82 to -71.09)
-53.81
(-64.41 to -43.22)
-84.82
(-89.50 to -80.15)
-61.23
(-69.29 to -53.17)
-57.24
(-68.80 to -45.69)
-39.68
(-50.92 to -28.44)
Week 12 Number Analyzed 22 participants 21 participants 21 participants 21 participants 27 participants 19 participants 25 participants 17 participants
-71.94
(-84.67 to -59.21)
-58.52
(-69.38 to -47.67)
-74.42
(-84.98 to -63.87)
-51.49
(-63.21 to -39.78)
-88.68
(-93.13 to -84.22)
-57.81
(-68.52 to -47.10)
-58.57
(-70.05 to -47.09)
-40.27
(-52.68 to -27.86)
Week 14 Number Analyzed 21 participants 21 participants 21 participants 22 participants 27 participants 19 participants 24 participants 16 participants
-64.15
(-78.24 to -50.05)
-47.87
(-62.17 to -33.56)
-63.20
(-74.36 to -52.05)
-44.30
(-57.51 to -31.09)
-83.39
(-89.74 to -77.04)
-47.84
(-60.18 to -35.49)
-47.52
(-59.86 to -35.18)
-39.48
(-52.09 to -26.88)
Week 16 Number Analyzed 21 participants 21 participants 20 participants 21 participants 26 participants 18 participants 23 participants 16 participants
-57.28
(-72.02 to -42.54)
-38.48
(-51.85 to -25.10)
-60.56
(-72.71 to -48.42)
-36.63
(-51.43 to -21.83)
-74.18
(-83.22 to -65.15)
-44.58
(-58.96 to -30.19)
-42.29
(-59.96 to -24.63)
-38.79
(-51.92 to -25.66)
9.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or an important medical event. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
Time Frame From first dose of study treatment (Day 1) up to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo).
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Hide Arm/Group Description:
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 12 weeks of blinded matching placebo QD tablets.
Overall Number of Participants Analyzed 25 29 26 25 29 25 30 23
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment-emergent AEs
19
  76.0%
21
  72.4%
18
  69.2%
18
  72.0%
21
  72.4%
16
  64.0%
23
  76.7%
13
  56.5%
Treatment-emergent SAEs
2
   8.0%
1
   3.4%
1
   3.8%
1
   4.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs
Hide Description The number of participants who discontinued from the study due to treatment-emergent AEs is presented. Note for data reported under this Outcome Measure: Per sponsor reporting standard, pregnancy was counted as AE for AE data tables while it was counted separately in the disposition data table (Participant Flow Module).
Time Frame From first dose of study treatment (Day 1) up to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo).
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Hide Arm/Group Description:
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 12 weeks of blinded matching placebo QD tablets.
Overall Number of Participants Analyzed 25 29 26 25 29 25 30 23
Measure Type: Count of Participants
Unit of Measure: Participants
2
   8.0%
4
  13.8%
1
   3.8%
2
   8.0%
0
   0.0%
2
   8.0%
2
   6.7%
0
   0.0%
11.Secondary Outcome
Title Change From Baseline in Blood Lipid Level at Weeks 4 and 12
Hide Description Lipid panel included low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides.
Time Frame Baseline (Day 1 pre-dose), Weeks 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of participants analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo). "Number analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had data for each specified category.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Hide Arm/Group Description:
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 12 weeks of blinded matching placebo QD tablets.
Overall Number of Participants Analyzed 25 29 26 25 29 25 30 23
Mean (90% Confidence Interval)
Unit of Measure: milligram per deciliter (mg/dL)
LDL Cholesterol, Week 4 Number Analyzed 22 participants 26 participants 21 participants 24 participants 23 participants 24 participants 25 participants 18 participants
15.91
(7.95 to 23.86)
11.27
(4.31 to 18.23)
15.00
(-0.63 to 30.63)
15.88
(6.63 to 25.12)
8.96
(0.99 to 16.92)
-2.21
(-11.04 to 6.63)
7.60
(-4.39 to 19.59)
-6.28
(-10.56 to -2.00)
LDL Cholesterol, Week 12 Number Analyzed 21 participants 20 participants 19 participants 20 participants 20 participants 18 participants 22 participants 15 participants
8.71
(1.04 to 16.39)
6.00
(-4.73 to 16.73)
-0.74
(-11.67 to 10.20)
6.85
(-2.06 to 15.76)
14.10
(6.63 to 21.57)
-5.33
(-18.24 to 7.57)
3.95
(-7.79 to 15.70)
-4.00
(-9.71 to 1.71)
HDL Cholesterol, Week 4 Number Analyzed 23 participants 28 participants 25 participants 24 participants 28 participants 25 participants 28 participants 19 participants
12.09
(8.07 to 16.11)
9.14
(5.84 to 12.45)
10.92
(7.38 to 14.46)
8.58
(5.84 to 11.33)
6.36
(3.91 to 8.80)
6.76
(2.93 to 10.59)
9.39
(7.03 to 11.75)
0.00
(-5.14 to 5.14)
HDL Cholesterol, Week 12 Number Analyzed 22 participants 21 participants 21 participants 21 participants 27 participants 19 participants 24 participants 15 participants
5.00
(1.29 to 8.71)
5.48
(1.66 to 9.29)
2.48
(-0.31 to 5.26)
-0.24
(-2.55 to 2.08)
4.74
(1.30 to 8.18)
4.37
(1.04 to 7.70)
2.88
(-0.24 to 5.99)
-2.73
(-6.32 to 0.85)
Total Cholesterol, Week 4 Number Analyzed 23 participants 28 participants 25 participants 24 participants 28 participants 25 participants 28 participants 19 participants
34.39
(24.01 to 44.77)
29.46
(18.68 to 40.25)
31.32
(15.20 to 47.44)
26.33
(15.85 to 36.82)
15.14
(-0.16 to 30.45)
10.36
(-1.70 to 22.42)
14.00
(0.14 to 27.86)
-4.42
(-10.90 to 2.06)
Total Cholesterol, Week 12 Number Analyzed 22 participants 21 participants 21 participants 21 participants 27 participants 19 participants 24 participants 15 participants
19.50
(9.95 to 29.05)
15.67
(2.74 to 28.59)
-1.86
(-13.78 to 10.07)
7.05
(-3.25 to 17.35)
20.37
(3.06 to 37.68)
0.68
(-14.51 to 15.87)
4.33
(-8.86 to 17.53)
-6.40
(-13.68 to 0.88)
Triglycerides, Week 4 Number Analyzed 23 participants 28 participants 25 participants 24 participants 28 participants 25 participants 28 participants 19 participants
34.74
(-8.43 to 77.91)
29.68
(10.42 to 48.94)
8.04
(-20.07 to 36.15)
8.92
(-21.83 to 39.66)
-65.11
(-204.94 to 74.72)
19.60
(-3.04 to 42.24)
-59.75
(-157.79 to 38.29)
15.26
(-11.07 to 41.60)
Triglycerides, Week 12 Number Analyzed 22 participants 21 participants 21 participants 21 participants 27 participants 19 participants 24 participants 15 participants
27.86
(-4.68 to 60.41)
48.33
(-32.67 to 129.34)
-85.00
(-213.81 to 43.81)
2.67
(-27.36 to 32.70)
-18.96
(-198.51 to 160.59)
6.32
(-19.21 to 31.84)
-67.79
(-185.53 to 49.95)
1.87
(-24.28 to 28.01)
12.Secondary Outcome
Title Number of Participants With Any Post-Baseline Laboratory Test Abnormalities
Hide Description Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio; chemistry (total bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, total cholesterol, LDL and HDL cholesterol, triglycerides, calcium, sodium, potassium, chloride, bicarbonate, glucose, creatine kinase, Cystatin C, glomerular filtration rate; urinalysis (pH, urine glucose, ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, bacteria, choriogonadotropin beta).
Time Frame From first dose of study treatment (Day 1) up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had post-baseline laboratory data.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Hide Arm/Group Description:
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 12 weeks of blinded matching placebo QD tablets.
Overall Number of Participants Analyzed 25 29 25 25 28 25 30 23
Measure Type: Count of Participants
Unit of Measure: Participants
17
  68.0%
20
  69.0%
20
  80.0%
16
  64.0%
21
  75.0%
20
  80.0%
18
  60.0%
11
  47.8%
13.Secondary Outcome
Title Number of Participants With Post-Baseline Vital Sign Abnormalities
Hide Description Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) <50 mmHg; 3) sitting pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP >=30 mmHg.
Time Frame From first dose of study treatment (Day 1) up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had post-baseline vital signs data.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Hide Arm/Group Description:
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 12 weeks of blinded matching placebo QD tablets.
Overall Number of Participants Analyzed 25 29 25 25 28 25 30 23
Measure Type: Count of Participants
Unit of Measure: Participants
Sitting DBP <50 mm Hg
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sitting DBP increase >=20 mm Hg
1
   4.0%
1
   3.4%
3
  12.0%
2
   8.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sitting DBP decrease >=20 mm Hg
3
  12.0%
0
   0.0%
2
   8.0%
2
   8.0%
1
   3.6%
2
   8.0%
2
   6.7%
1
   4.3%
Sitting SBP <90 mm Hg
1
   4.0%
1
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sitting SBP increase >=30 mm Hg
1
   4.0%
3
  10.3%
2
   8.0%
1
   4.0%
0
   0.0%
1
   4.0%
0
   0.0%
0
   0.0%
Sitting SBP decrease >=30 mm Hg
2
   8.0%
2
   6.9%
1
   4.0%
2
   8.0%
1
   3.6%
3
  12.0%
2
   6.7%
1
   4.3%
Sitting pulse rate <40 bpm
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sitting pulse rate >120 bpm
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
Hide Description ECG categorical summarization criteria: 1) QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): >=140 milliseconds (msec), >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to <480 msec, 480 to <500 msec, >=500 msec; a change from baseline of 30 to <60 msec or >=60 msec.
Time Frame From first dose of study treatment (Day 1) up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had post-baseline ECG data.
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Hide Arm/Group Description:
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Participants received 12 weeks of blinded matching placebo QD tablets.
Overall Number of Participants Analyzed 24 29 25 25 28 25 28 22
Measure Type: Count of Participants
Unit of Measure: Participants
PR interval >=300 msec
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
1
   3.6%
0
   0.0%
0
   0.0%
0
   0.0%
%Change in PR interval >=25/50%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
0
   0.0%
QRS duration >=140 msec
0
   0.0%
1
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
%Change in QRS duration >=50%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.6%
0
   0.0%
QT interval >=500 msec
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
QTc >=450 to <480 msec
6
  25.0%
1
   3.4%
2
   8.0%
0
   0.0%
1
   3.6%
1
   4.0%
0
   0.0%
1
   4.5%
QTc >=480 to <500 msec
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.5%
QTc >=500 msec
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
QTc change >=30 to <60 msec
2
   8.3%
0
   0.0%
2
   8.0%
1
   4.0%
3
  10.7%
3
  12.0%
0
   0.0%
1
   4.5%
QTc change >=60 msec
0
   0.0%
0
   0.0%
2
   8.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.5%
Time Frame From first dose of study treatment up to 20 weeks
Adverse Event Reporting Description The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
Hide Arm/Group Description Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). Participants received 12 weeks of blinded matching placebo QD tablets.
All-Cause Mortality
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
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   1/25 (4.00%)      0/29 (0.00%)      0/26 (0.00%)      0/25 (0.00%)      0/29 (0.00%)      0/25 (0.00%)      0/30 (0.00%)      0/23 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
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   2/25 (8.00%)      1/29 (3.45%)      1/26 (3.85%)      1/25 (4.00%)      0/29 (0.00%)      0/25 (0.00%)      0/30 (0.00%)      0/23 (0.00%)    
Blood and lymphatic system disorders                 
Anaemia * 1  0/25 (0.00%)  0 1/29 (3.45%)  1 0/26 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0 0/25 (0.00%)  0 0/30 (0.00%)  0 0/23 (0.00%)  0
Cardiac disorders                 
Angina pectoris * 1  1/25 (4.00%)  1 0/29 (0.00%)  0 0/26 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0 0/25 (0.00%)  0 0/30 (0.00%)  0 0/23 (0.00%)  0
General disorders                 
Chest pain * 1  0/25 (0.00%)  0 0/29 (0.00%)  0 0/26 (0.00%)  0 1/25 (4.00%)  1 0/29 (0.00%)  0 0/25 (0.00%)  0 0/30 (0.00%)  0 0/23 (0.00%)  0
Infections and infestations                 
Pneumonia * 1  0/25 (0.00%)  0 0/29 (0.00%)  0 1/26 (3.85%)  1 0/25 (0.00%)  0 0/29 (0.00%)  0 0/25 (0.00%)  0 0/30 (0.00%)  0 0/23 (0.00%)  0
Sepsis * 1  0/25 (0.00%)  0 0/29 (0.00%)  0 1/26 (3.85%)  1 0/25 (0.00%)  0 0/29 (0.00%)  0 0/25 (0.00%)  0 0/30 (0.00%)  0 0/23 (0.00%)  0
Injury, poisoning and procedural complications                 
Gun shot wound * 1  1/25 (4.00%)  1 0/29 (0.00%)  0 0/26 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0 0/25 (0.00%)  0 0/30 (0.00%)  0 0/23 (0.00%)  0
1
Term from vocabulary, MedDRA v20.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD PF-06700841 60 mg QD Followed by 10 mg QD PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) PF-06700841 60 mg QD Followed by Placebo PF-06700841 30 mg QD PF-06700841 30 mg QD Followed by 10 mg QD PF-06700841 30 mg QD Followed by 100 mg QW Placebo
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   11/25 (44.00%)      14/29 (48.28%)      13/26 (50.00%)      13/25 (52.00%)      13/29 (44.83%)      12/25 (48.00%)      16/30 (53.33%)      9/23 (39.13%)    
Gastrointestinal disorders                 
Diarrhoea * 1  0/25 (0.00%)  0 1/29 (3.45%)  1 0/26 (0.00%)  0 1/25 (4.00%)  1 0/29 (0.00%)  0 1/25 (4.00%)  1 3/30 (10.00%)  4 1/23 (4.35%)  1
Nausea * 1  1/25 (4.00%)  1 1/29 (3.45%)  1 1/26 (3.85%)  1 2/25 (8.00%)  2 0/29 (0.00%)  0 0/25 (0.00%)  0 1/30 (3.33%)  1 2/23 (8.70%)  2
Cheilitis * 1  0/25 (0.00%)  0 0/29 (0.00%)  0 0/26 (0.00%)  0 0/25 (0.00%)  0 2/29 (6.90%)  2 0/25 (0.00%)  0 0/30 (0.00%)  0 0/23 (0.00%)  0
Vomiting * 1  0/25 (0.00%)  0 1/29 (3.45%)  1 1/26 (3.85%)  1 1/25 (4.00%)  1 0/29 (0.00%)  0 2/25 (8.00%)  2 0/30 (0.00%)  0 0/23 (0.00%)  0
General disorders                 
Fatigue * 1  1/25 (4.00%)  1 1/29 (3.45%)  1 1/26 (3.85%)  1 2/25 (8.00%)  2 0/29 (0.00%)  0 1/25 (4.00%)  1 0/30 (0.00%)  0 1/23 (4.35%)  1
Infections and infestations                 
Upper respiratory tract infection * 1  2/25 (8.00%)  2 1/29 (3.45%)  1 5/26 (19.23%)  5 1/25 (4.00%)  1 2/29 (6.90%)  2 0/25 (0.00%)  0 3/30 (10.00%)  3 1/23 (4.35%)  1
Bronchitis * 1  0/25 (0.00%)  0 2/29 (6.90%)  2 0/26 (0.00%)  0 0/25 (0.00%)  0 2/29 (6.90%)  2 0/25 (0.00%)  0 0/30 (0.00%)  0 0/23 (0.00%)  0
Nasopharyngitis * 1  4/25 (16.00%)  4 3/29 (10.34%)  4 3/26 (11.54%)  3 3/25 (12.00%)  3 5/29 (17.24%)  6 6/25 (24.00%)  6 4/30 (13.33%)  5 3/23 (13.04%)  3
Sinusitis * 1  1/25 (4.00%)  1 0/29 (0.00%)  0 1/26 (3.85%)  2 2/25 (8.00%)  2 0/29 (0.00%)  0 0/25 (0.00%)  0 1/30 (3.33%)  1 0/23 (0.00%)  0
Urinary tract infection * 1  0/25 (0.00%)  0 1/29 (3.45%)  1 1/26 (3.85%)  1 0/25 (0.00%)  0 0/29 (0.00%)  0 1/25 (4.00%)  1 2/30 (6.67%)  2 0/23 (0.00%)  0
Injury, poisoning and procedural complications                 
Ligament sprain * 1  0/25 (0.00%)  0 1/29 (3.45%)  1 0/26 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0 2/25 (8.00%)  2 0/30 (0.00%)  0 0/23 (0.00%)  0
Investigations                 
Neutrophil count decreased * 1  0/25 (0.00%)  0 0/29 (0.00%)  0 1/26 (3.85%)  1 0/25 (0.00%)  0 2/29 (6.90%)  2 0/25 (0.00%)  0 1/30 (3.33%)  1 0/23 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Back pain * 1  1/25 (4.00%)  1 2/29 (6.90%)  2 0/26 (0.00%)  0 0/25 (0.00%)  0 2/29 (6.90%)  2 2/25 (8.00%)  2 1/30 (3.33%)  2 2/23 (8.70%)  2
Arthralgia * 1  1/25 (4.00%)  3 2/29 (6.90%)  2 0/26 (0.00%)  0 0/25 (0.00%)  0 1/29 (3.45%)  1 1/25 (4.00%)  1 1/30 (3.33%)  1 1/23 (4.35%)  1
Nervous system disorders                 
Headache * 1  1/25 (4.00%)  1 2/29 (6.90%)  2 3/26 (11.54%)  3 3/25 (12.00%)  3 4/29 (13.79%)  6 1/25 (4.00%)  1 0/30 (0.00%)  0 1/23 (4.35%)  1
Psychiatric disorders                 
Irritability * 1  0/25 (0.00%)  0 0/29 (0.00%)  0 0/26 (0.00%)  0 2/25 (8.00%)  2 0/29 (0.00%)  0 0/25 (0.00%)  0 0/30 (0.00%)  0 0/23 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Oropharyngeal pain * 1  0/25 (0.00%)  0 0/29 (0.00%)  0 1/26 (3.85%)  1 0/25 (0.00%)  0 2/29 (6.90%)  2 0/25 (0.00%)  0 0/30 (0.00%)  0 0/23 (0.00%)  0
Skin and subcutaneous tissue disorders                 
Psoriasis * 1  0/25 (0.00%)  0 1/29 (3.45%)  1 3/26 (11.54%)  3 1/25 (4.00%)  1 0/29 (0.00%)  0 2/25 (8.00%)  2 0/30 (0.00%)  0 0/23 (0.00%)  0
Pruritus * 1  0/25 (0.00%)  0 0/29 (0.00%)  0 1/26 (3.85%)  1 3/25 (12.00%)  4 1/29 (3.45%)  1 0/25 (0.00%)  0 1/30 (3.33%)  2 0/23 (0.00%)  0
Acne * 1  0/25 (0.00%)  0 2/29 (6.90%)  2 0/26 (0.00%)  0 2/25 (8.00%)  2 0/29 (0.00%)  0 0/25 (0.00%)  0 2/30 (6.67%)  2 0/23 (0.00%)  0
Vascular disorders                 
Hot flush * 1  0/25 (0.00%)  0 0/29 (0.00%)  0 0/26 (0.00%)  0 2/25 (8.00%)  2 0/29 (0.00%)  0 0/25 (0.00%)  0 0/30 (0.00%)  0 0/23 (0.00%)  0
1
Term from vocabulary, MedDRA v20.1
*
Indicates events were collected by non-systematic assessment
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02969018     History of Changes
Other Study ID Numbers: B7931004
2016-004049-96 ( EudraCT Number )
First Submitted: November 17, 2016
First Posted: November 21, 2016
Results First Submitted: February 13, 2019
Results First Posted: March 29, 2019
Last Update Posted: March 29, 2019