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Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

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: NCT02958865
Recruitment Status : Completed
First Posted : November 8, 2016
Results First Posted : July 21, 2022
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Drug: PF-06651600 or Placebo
Drug: PF-06700841 or Placebo
Drug: PF-06700841
Drug: PF-06651600
Enrollment 319
Recruitment Details The study consisted of a screening period of up to 6 weeks, an 8-week double-blind induction period, and an additional 24-week open-label active chronic dosing period followed by a 4-week follow up period after the last dose of investigational product.
Pre-assignment Details A total of 319 participants were randomized and 317 participants were treated.
Arm/Group Title Placebo (Induction) PF-06651600 20 mg (Induction) PF-06651600 70 mg (Induction) PF-06651600 200 mg (Induction) PF-06700841 10 mg (Induction) PF-06700841 30 mg (Induction) PF-06700841 60 mg (Induction) PF-06651600 200 mg -> PF-06651600 50 mg PF-06651600 70 mg -> PF-06651600 50 mg PF-06651600 20 mg -> PF-06651600 50 mg Placebo -> PF-06651600 50 mg PF-06700841 60 mg -> PF-06700841 30 mg PF-06700841 30 mg -> PF-06700841 30 mg PF-06700841 10 mg -> PF-06700841 30 mg Placebo -> PF-06700841 30 mg Pooling Placebo During Chronic
Hide Arm/Group Description The placebo was administered orally once daily (QD) from Day 1 to Week 8. PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8. PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8. PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8. PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8. PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8. PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8. PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32. PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32. PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32. The placebo was administered orally QD from Day 1 to Week 8 and PF-06651600 was administered at 50 mg QD from Week 9 to Week 32. PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32. PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32. PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32. The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32. The placebo was administered orally QD from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
Period Title: Induction Period (Day 1 to Week 8)
Started 25 51 49 50 48 47 47 0 0 0 0 0 0 0 0 0
Completed 21 44 43 41 45 43 44 0 0 0 0 0 0 0 0 0
Not Completed 4 7 6 9 3 4 3 0 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             0             4             0             5             1             2             1             0             0             0             0             0             0             0             0             0
Death             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Physician Decision             1             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             2             0             3             1             1             1             1             0             0             0             0             0             0             0             0             0
No longer meeting eligibility criteria             0             0             0             1             0             0             1             0             0             0             0             0             0             0             0             0
Protocol Violation             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0
Lack of Efficacy             1             1             1             0             0             0             0             0             0             0             0             0             0             0             0             0
Other             0             0             1             2             0             1             0             0             0             0             0             0             0             0             0             0
Lost to Follow-up             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0             0
Period Title: Chronic Period (Week 8 to Week 32)
Started 0 0 0 0 0 0 0 35 36 39 10 38 37 39 9 37
Completed 0 0 0 0 0 0 0 33 33 33 10 31 26 31 5 20
Not Completed 0 0 0 0 0 0 0 2 3 6 0 7 11 8 4 17
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             1             1             2             0             1             4             1             1             5
Lack of Efficacy             0             0             0             0             0             0             0             0             2             1             0             5             0             2             0             8
Pregnancy             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             1
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             0             1             6             3             3             2
Other             0             0             0             0             0             0             0             1             0             1             0             0             1             0             0             1
Non-compliance with study drug             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0
Protocol Violation             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0
No longer meeting eligibility criteria             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0
Arm/Group Title Placebo (Induction) PF-06651600 20 mg (Induction) PF-06651600 70 mg (Induction) PF-06651600 200 mg (Induction) PF-06700841 10 mg (Induction) PF-06700841 30 mg (Induction) PF-06700841 60 mg (Induction) Total
Hide Arm/Group Description The placebo was administered orally once daily (QD) from Day 1 to Week 8. PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8. PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8. PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8. PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8. PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8. PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8. Total of all reporting groups
Overall Number of Baseline Participants 25 51 49 50 48 47 47 317
Hide Baseline Analysis Population Description
All randomized participants who received at least 1 dose of PF-06651600, PF-06700841, or placebo.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 51 participants 49 participants 50 participants 48 participants 47 participants 47 participants 317 participants
42.8  (15.45) 41.3  (14.03) 40.2  (13.31) 37.3  (15.67) 40.8  (13.04) 40.9  (13.03) 40.3  (12.80) 40.3  (13.79)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 51 participants 49 participants 50 participants 48 participants 47 participants 47 participants 317 participants
18-44 years
13
  52.0%
31
  60.8%
30
  61.2%
36
  72.0%
31
  64.6%
25
  53.2%
30
  63.8%
196
  61.8%
45-64 years
10
  40.0%
16
  31.4%
18
  36.7%
10
  20.0%
16
  33.3%
22
  46.8%
16
  34.0%
108
  34.1%
>=65 years
2
   8.0%
4
   7.8%
1
   2.0%
4
   8.0%
1
   2.1%
0
   0.0%
1
   2.1%
13
   4.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 51 participants 49 participants 50 participants 48 participants 47 participants 47 participants 317 participants
Female
11
  44.0%
17
  33.3%
25
  51.0%
18
  36.0%
18
  37.5%
24
  51.1%
22
  46.8%
135
  42.6%
Male
14
  56.0%
34
  66.7%
24
  49.0%
32
  64.0%
30
  62.5%
23
  48.9%
25
  53.2%
182
  57.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 51 participants 49 participants 50 participants 48 participants 47 participants 47 participants 317 participants
White
22
  88.0%
46
  90.2%
46
  93.9%
48
  96.0%
44
  91.7%
44
  93.6%
45
  95.7%
295
  93.1%
Black or African American
1
   4.0%
1
   2.0%
2
   4.1%
1
   2.0%
0
   0.0%
0
   0.0%
1
   2.1%
6
   1.9%
Asian
1
   4.0%
3
   5.9%
1
   2.0%
0
   0.0%
3
   6.3%
3
   6.4%
0
   0.0%
11
   3.5%
Other (not specified)
1
   4.0%
1
   2.0%
0
   0.0%
1
   2.0%
1
   2.1%
0
   0.0%
1
   2.1%
5
   1.6%
1.Primary Outcome
Title Total Mayo Score at Week 8 (Induction Period)
Hide Description The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicates more severe disease activity and lower score denotes improvement of disease activity as measured by the total Mayo score.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
Arm/Group Title Placebo (Induction) PF-06651600 20 mg (Induction) PF-06651600 70 mg (Induction) PF-06651600 200 mg (Induction) PF-06700841 10 mg (Induction) PF-06700841 30 mg (Induction) PF-06700841 60 mg (Induction)
Hide Arm/Group Description:
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
Overall Number of Participants Analyzed 25 51 49 50 48 47 47
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Units on a scale
7.88
(6.95 to 8.81)
5.85
(5.18 to 6.51)
4.00
(3.33 to 4.67)
3.27
(2.58 to 3.96)
6.08
(5.43 to 6.74)
5.60
(4.93 to 6.27)
4.67
(4.01 to 5.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction), PF-06651600 20 mg (Induction)
Comments The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.03
Confidence Interval (2-Sided) 90%
-3.17 to -0.89
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction), PF-06651600 70 mg (Induction)
Comments The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.88
Confidence Interval (2-Sided) 90%
-5.01 to -2.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Induction), PF-06651600 200 mg (Induction)
Comments The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.61
Confidence Interval (2-Sided) 90%
-5.76 to -3.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (Induction), PF-06700841 10 mg (Induction)
Comments The null hypothesis was that the there is no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm is declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect is below zero.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0045
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.79
Confidence Interval (2-Sided) 90%
-2.92 to -0.67
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (Induction), PF-06700841 30 mg (Induction)
Comments The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.28
Confidence Interval (2-Sided) 90%
-3.41 to -1.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo (Induction), PF-06700841 60 mg (Induction)
Comments The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.21
Confidence Interval (2-Sided) 90%
-4.34 to -2.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.69
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period)
Hide Description An AE was an 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: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs mentioned below are treatment-emergent AEs.
Time Frame From Week 8 up to Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was defined as those participants who received at least one dose of PF-06651600, PF-06700841, or placebo.
Arm/Group Title PF-06651600 200 mg -> PF-06651600 50 mg PF-06651600 70 mg -> PF-06651600 50 mg PF-06651600 20 mg -> PF-06651600 50 mg Placebo -> PF-06651600 50 mg PF-06700841 60 mg -> PF-06700841 30 mg PF-06700841 30 mg -> PF-06700841 30 mg PF-06700841 10 mg -> PF-06700841 30 mg Placebo -> PF-06700841 30 mg Pooling Placebo During Chronic
Hide Arm/Group Description:
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
mg The placebo was administered orally from Day 1 to Week 8 and PF-06651600 at 50 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
Overall Number of Participants Analyzed 35 36 39 10 38 37 39 9 37
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with AEs
18
  51.4%
27
  75.0%
18
  46.2%
8
  80.0%
21
  55.3%
23
  62.2%
26
  66.7%
4
  44.4%
18
  48.6%
Participants with SAEs
3
   8.6%
1
   2.8%
1
   2.6%
0
   0.0%
2
   5.3%
4
  10.8%
2
   5.1%
0
   0.0%
0
   0.0%
Participants discontinued from study due to AEs
1
   2.9%
1
   2.8%
3
   7.7%
1
  10.0%
1
   2.6%
4
  10.8%
1
   2.6%
1
  11.1%
6
  16.2%
3.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities (Chronic Period)
Hide Description The number of participants with a laboratory abnormality meeting the pre-specified criteria defined in the study protocol while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. Laboratory data included hematology test, serum chemistry test, C-creative protein and viral surveillance.
Time Frame From Week 8 to Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
The participants with at least one observation of the given laboratory test while on study treatment or during lag time.
Arm/Group Title PF-06651600 200 mg -> PF-06651600 50 mg PF-06651600 70 mg -> PF-06651600 50 mg PF-06651600 20 mg -> PF-06651600 50 mg Placebo -> PF-06651600 50 mg PF-06700841 60 mg -> PF-06700841 30 mg PF-06700841 30 mg -> PF-06700841 30 mg PF-06700841 10 mg -> PF-06700841 30 mg Placebo -> PF-06700841 30 mg Pooling Placebo During Chronic
Hide Arm/Group Description:
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
The placebo was administered orally from Day 1 to Week 8 and PF-06651600 at 50 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
Overall Number of Participants Analyzed 35 35 39 10 38 37 39 9 37
Measure Type: Count of Participants
Unit of Measure: Participants
27
  77.1%
31
  88.6%
33
  84.6%
8
  80.0%
29
  76.3%
27
  73.0%
28
  71.8%
8
  88.9%
23
  62.2%
4.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Hide Description The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of hematology test parameters were as follows: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils (absolute, Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs), prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT), and reticulocytes (% and Abs). Percentages are displayed for the laboratory tests having a category with greater or equal to 1 evaluable participant.
Time Frame From Week 8 to Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
Arm/Group Title PF-06651600 200 mg -> PF-06651600 50 mg PF-06651600 70 mg -> PF-06651600 50 mg PF-06651600 20 mg -> PF-06651600 50 mg Placebo -> PF-06651600 50 mg PF-06700841 60 mg -> PF-06700841 30 mg PF-06700841 30 mg -> PF-06700841 30 mg PF-06700841 10 mg -> PF-06700841 30 mg Placebo -> PF-06700841 30 mg Pooling Placebo During Chronic
Hide Arm/Group Description:
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
The placebo was administered orally from Day 1 to Week 8 and PF-06651600 at 50 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
Overall Number of Participants Analyzed 35 36 39 10 38 37 39 9 37
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin (g/dL) <0.8× LLN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 36 participants
2
   5.7%
2
   5.7%
1
   2.6%
1
  10.0%
3
   7.9%
3
   8.1%
6
  15.4%
2
  22.2%
3
   8.3%
Hematocrit (%) <0.8× LLN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 36 participants
0
   0.0%
2
   5.7%
1
   2.6%
0
   0.0%
1
   2.6%
1
   2.7%
1
   2.6%
1
  11.1%
2
   5.6%
Erythrocytes (10^6/mm^3) <0.8× LLN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 36 participants
0
   0.0%
1
   2.9%
1
   2.6%
0
   0.0%
1
   2.6%
0
   0.0%
1
   2.6%
1
  11.1%
1
   2.8%
Reticulocytes (Abs) (10^3/mm^3) >1.5× ULN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 36 participants 39 participants 9 participants 36 participants
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN Number Analyzed 3 participants 2 participants 1 participants 0 participants 1 participants 2 participants 1 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
1
 100.0%
 0
0
   0.0%
1
  50.0%
0
   0.0%
 0 0
Platelets (10^3/mm^3) >1.75× ULN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 36 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   7.9%
1
   2.7%
2
   5.1%
0
   0.0%
2
   5.6%
Reticulocytes/Erythrocytes (%) >1.5× ULN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 36 participants 39 participants 9 participants 36 participants
1
   2.9%
1
   2.9%
2
   5.1%
0
   0.0%
1
   2.6%
1
   2.8%
0
   0.0%
0
   0.0%
1
   2.8%
Leukocytes (10^3/mm^3) >1.5× ULN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 36 participants
0
   0.0%
0
   0.0%
1
   2.6%
1
  10.0%
1
   2.6%
1
   2.7%
1
   2.6%
1
  11.1%
1
   2.8%
Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 36 participants
7
  20.0%
6
  17.1%
6
  15.4%
1
  10.0%
0
   0.0%
0
   0.0%
3
   7.7%
0
   0.0%
3
   8.3%
Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 36 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
Neutrophils (Abs) (10^3/mm^3) <0.8× LLN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 36 participants
1
   2.9%
2
   5.7%
0
   0.0%
0
   0.0%
3
   7.9%
1
   2.7%
2
   5.1%
1
  11.1%
1
   2.8%
Neutrophils (Abs) (10^3/mm^3) >1.2× ULN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 36 participants
3
   8.6%
8
  22.9%
11
  28.2%
1
  10.0%
8
  21.1%
6
  16.2%
6
  15.4%
3
  33.3%
6
  16.7%
Basophils (Abs) (10^3/mm^3) >1.2× ULN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 36 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   5.3%
1
   2.7%
0
   0.0%
0
   0.0%
1
   2.8%
Eosinophils (Abs) (10^3/mm^3) >1.2x ULN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 36 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   5.3%
1
   2.7%
0
   0.0%
0
   0.0%
2
   5.6%
Monocytes (Abs) (10^3/mm^3) >1.2× ULN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 36 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   5.3%
2
   5.4%
0
   0.0%
0
   0.0%
0
   0.0%
Activated PTT (second) >1.1× ULN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 36 participants
0
   0.0%
3
   8.6%
1
   2.6%
0
   0.0%
2
   5.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PT (second) >1.1× ULN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 36 participants
2
   5.7%
3
   8.6%
2
   5.1%
0
   0.0%
2
   5.3%
2
   5.4%
0
   0.0%
0
   0.0%
0
   0.0%
Prothrombin INR >1.1× ULN Number Analyzed 35 participants 35 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 36 participants
2
   5.7%
3
   8.6%
2
   5.1%
0
   0.0%
2
   5.3%
1
   2.7%
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Participants With Abnormal Vital Signs Data (Chronic Period)
Hide Description The vital signs data included the single sitting blood pressure, pulse rate and temperature. The criteria of vital sign abnormality are indicated below.
Time Frame From Week 8 to Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
The participants evaluated against the criteria during the chronic period.
Arm/Group Title PF-06651600 200 mg -> PF-06651600 50 mg PF-06651600 70 mg -> PF-06651600 50 mg PF-06651600 20 mg -> PF-06651600 50 mg Placebo -> PF-06651600 50 mg PF-06700841 60 mg -> PF-06700841 30 mg PF-06700841 30 mg -> PF-06700841 30 mg PF-06700841 10 mg -> PF-06700841 30 mg Placebo -> PF-06700841 30 mg Pooling Placebo During Chronic
Hide Arm/Group Description:
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
The placebo was administered orally from Day 1 to Week 8 and PF-06651600 at 50 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
Overall Number of Participants Analyzed 35 35 39 10 38 37 39 9 37
Measure Type: Count of Participants
Unit of Measure: Participants
Sitting Systolic Blood Pressure Value <90 mmHg
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
1
   2.7%
Sitting Systolic Blood Pressure Change ≥30 mmHg Increase
0
   0.0%
3
   8.6%
4
  10.3%
0
   0.0%
3
   7.9%
2
   5.4%
3
   7.7%
0
   0.0%
3
   8.1%
Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.6%
1
   2.7%
0
   0.0%
0
   0.0%
1
   2.7%
Sitting Diastolic Blood Pressure Value <50 mmHg
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%
Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase
0
   0.0%
1
   2.9%
6
  15.4%
1
  10.0%
4
  10.5%
2
   5.4%
1
   2.6%
1
  11.1%
1
   2.7%
Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease
2
   5.7%
4
  11.4%
5
  12.8%
0
   0.0%
2
   5.3%
3
   8.1%
1
   2.6%
0
   0.0%
2
   5.4%
Sitting Pulse Rate Value <40 beat per minute (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%
0
   0.0%
Sitting Pulse Rate Value >120 bpm
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Number of Participants With Abnormal ECG Findings (Chronic Period)
Hide Description The number of participants with abnormal ECG findings during the chronic period (from Week 9 to Week 32) are reported below.
Time Frame Week 8 to Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
The participants evaluated against the criteria during the chronic period.
Arm/Group Title PF-06651600 200 mg -> PF-06651600 50 mg PF-06651600 70 mg -> PF-06651600 50 mg PF-06651600 20 mg -> PF-06651600 50 mg Placebo -> PF-06651600 50 mg PF-06700841 60 mg -> PF-06700841 30 mg PF-06700841 30 mg -> PF-06700841 30 mg PF-06700841 10 mg -> PF-06700841 30 mg Placebo -> PF-06700841 30 mg Pooling Placebo During Chronic
Hide Arm/Group Description:
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
The placebo was administered orally from Day 1 to Week 8 and PF-06651600 at 50 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
Overall Number of Participants Analyzed 35 36 39 10 38 37 36 9 37
Measure Type: Count of Participants
Unit of Measure: Participants
Abnormal, not clinically significant
3
   8.6%
6
  16.7%
2
   5.1%
1
  10.0%
1
   2.6%
2
   5.4%
4
  11.1%
2
  22.2%
4
  10.8%
Abnormal, clinically significant
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%
7.Secondary Outcome
Title Number of Participants With Serious Infections (Chronic Period)
Hide Description Serious infections was defined as any infection (for example, viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials.
Time Frame Week 8 to Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
The participants who received at least one dose of PF-06651600, PF-06700841, or placebo.
Arm/Group Title PF-06651600 200 mg -> PF-06651600 50 mg PF-06651600 70 mg -> PF-06651600 50 mg PF-06651600 20 mg -> PF-06651600 50 mg Placebo -> PF-06651600 50 mg PF-06700841 60 mg -> PF-06700841 30 mg PF-06700841 30 mg -> PF-06700841 30 mg PF-06700841 10 mg -> PF-06700841 30 mg Placebo -> PF-06700841 30 mg Pooling Placebo During Chronic
Hide Arm/Group Description:
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
The placebo was administered orally from Day 1 to Week 8 and PF-06651600 at 50 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
Overall Number of Participants Analyzed 35 36 39 10 38 37 39 9 37
Measure Type: Count of Participants
Unit of Measure: Participants
COVID-19 pneumonia
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
Viral infection
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Hide Description The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of serum chemistry test parameters were as follows: blood urea nitrogen, creatinine, cystatin C, glucose, calcium, sodium, potassium, gamma glutamyl transferase, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, uric acid, albumin, total protein, creatine kinase (CK), total cholesterol, triglycerides, high-density lipoproteins (HDL), and low-density lipoprotein (LDL).
Time Frame Week 8 to Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
Arm/Group Title PF-06651600 200 mg -> PF-06651600 50 mg PF-06651600 70 mg -> PF-06651600 50 mg PF-06651600 20 mg -> PF-06651600 50 mg Placebo -> PF-06651600 50 mg PF-06700841 60 mg -> PF-06700841 30 mg PF-06700841 30 mg -> PF-06700841 30 mg PF-06700841 10 mg -> PF-06700841 30 mg Placebo -> PF-06700841 30 mg Pooling Placebo During Chronic
Hide Arm/Group Description:
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
The placebo was administered orally from Day 1 to Week 8 and PF-06651600 at 50 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
Overall Number of Participants Analyzed 35 36 39 10 38 37 39 9 37
Measure Type: Count of Participants
Unit of Measure: Participants
Bilirubin (mg/dL) >1.5 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
1
   2.9%
0
   0.0%
1
   2.6%
0
   0.0%
1
   2.6%
0
   0.0%
1
   2.6%
0
   0.0%
1
   2.7%
Direct Bilirubin (mg/dL) >1.5 x ULN Number Analyzed 3 participants 3 participants 6 participants 1 participants 6 participants 4 participants 4 participants 0 participants 4 participants
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%
Indirect Bilirubin (mg/dL) >1.5 x ULN Number Analyzed 2 participants 1 participants 2 participants 0 participants 2 participants 0 participants 2 participants 0 participants 1 participants
0
   0.0%
0
   0.0%
0
   0.0%
 0
0
   0.0%
 0
0
   0.0%
 0
0
   0.0%
AST (U/L) >3.0 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
0
   0.0%
0
   0.0%
2
   5.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT (U/L) >3.0 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
1
   2.9%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
2
   5.1%
0
   0.0%
0
   0.0%
Gamma Glutamyl Transferase (U/L) >3.0 x ULN Number Analyzed 2 participants 2 participants 2 participants 0 participants 2 participants 1 participants 2 participants 0 participants 1 participants
0
   0.0%
0
   0.0%
0
   0.0%
 0
0
   0.0%
0
   0.0%
0
   0.0%
 0
0
   0.0%
Alkaline Phosphatase (U/L) >3.0 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Protein (g/dL) <0.8 x LLN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
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%
Protein (g/dL) >1.2 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
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%
Albumin (g/dL) <0.8 x LLN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
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%
Albumin (g/dL) >1.2 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
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%
Urea Nitrogen (mg/dL) >1.3 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
0
   0.0%
1
   2.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine (mg/dL) >1.3 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
0
   0.0%
1
   2.8%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.7%
1
   2.6%
0
   0.0%
0
   0.0%
Urate (mg/dL) >1.2 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
0
   0.0%
2
   5.6%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.7%
1
   2.6%
0
   0.0%
0
   0.0%
HDL Cholesterol (mg/dL) <0.8 x LLN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
1
   2.9%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
LDL Cholesterol (mg/dL) >1.2 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
1
   2.9%
1
   2.8%
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
2
   5.1%
1
  11.1%
0
   0.0%
Triglycerides (mg/dL) >1.3 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
3
   8.6%
2
   5.6%
1
   2.6%
0
   0.0%
2
   5.3%
2
   5.4%
1
   2.6%
0
   0.0%
1
   2.7%
Sodium (Meq/L) <0.95 x LLN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
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%
Sodium (Meq/L) >1.05 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
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%
Potassium (Meq/L) <0.9 x LLN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.7%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium (Meq/L) >1.1 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
1
   2.9%
0
   0.0%
0
   0.0%
0
   0.0%
2
   5.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Chloride (Meq/L) <0.9 x LLN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
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%
Chloride (Meq/L) >1.1 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
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%
Calcium (mg/dL) <0.9 x LLN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.7%
0
   0.0%
0
   0.0%
0
   0.0%
Calcium (mg/dL) >1.1 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
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%
Glucose (mg/dL) <0.6 x LLN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
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%
Glucose (mg/dL) >1.5 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
1
   2.9%
3
   8.3%
3
   7.7%
0
   0.0%
1
   2.6%
2
   5.4%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin A1C (%) >1.3 x ULN Number Analyzed 3 participants 0 participants 1 participants 0 participants 3 participants 0 participants 1 participants 1 participants 2 participants
0
   0.0%
 0
0
   0.0%
 0
0
   0.0%
 0
0
   0.0%
0
   0.0%
0
   0.0%
Creatine Kinase (U/L) >2.0 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
1
   2.9%
3
   8.3%
2
   5.1%
1
  10.0%
3
   7.9%
10
  27.0%
2
   5.1%
0
   0.0%
1
   2.7%
Cholesterol (mg/dl) >1.3 x ULN Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
0
   0.0%
1
   2.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)
Hide Description The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of urinalysis test parameters were as follows:pH, glucose (qual), protein (qual), blood (qual), ketones, nitrites, leukocyte esterase, microscopy, and spot urine albumin/creatinine ratio. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.
Time Frame Week 8 to Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
Arm/Group Title PF-06651600 200 mg -> PF-06651600 50 mg PF-06651600 70 mg -> PF-06651600 50 mg PF-06651600 20 mg -> PF-06651600 50 mg Placebo -> PF-06651600 50 mg PF-06700841 60 mg -> PF-06700841 30 mg PF-06700841 30 mg -> PF-06700841 30 mg PF-06700841 10 mg -> PF-06700841 30 mg Placebo -> PF-06700841 30 mg Pooling Placebo During Chronic
Hide Arm/Group Description:
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
The placebo was administered orally from Day 1 to Week 8 and PF-06651600 at 50 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
Overall Number of Participants Analyzed 35 36 39 10 38 37 39 9 37
Measure Type: Count of Participants
Unit of Measure: Participants
pH (scalar) <4.5 Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
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%
pH (scalar) >8 Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
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%
Urine Glucose (No Unit) >=1 Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
1
   2.9%
2
   5.6%
1
   2.6%
1
  10.0%
1
   2.6%
1
   2.7%
0
   0.0%
0
   0.0%
1
   2.7%
Ketones (No Unit) >=1 Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
4
  11.4%
3
   8.3%
8
  20.5%
2
  20.0%
4
  10.5%
1
   2.7%
3
   7.7%
0
   0.0%
2
   5.4%
Urine Protein (No Unit) >=1 Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
0
   0.0%
1
   2.8%
3
   7.7%
0
   0.0%
1
   2.6%
0
   0.0%
2
   5.1%
0
   0.0%
1
   2.7%
Urine Hemoglobin (No Unit) >=1 Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
7
  20.0%
4
  11.1%
5
  12.8%
1
  10.0%
7
  18.4%
9
  24.3%
9
  23.1%
0
   0.0%
9
  24.3%
Nitrite (No Unit) >=1 Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
2
   5.7%
2
   5.6%
0
   0.0%
2
  20.0%
1
   2.6%
1
   2.7%
1
   2.6%
0
   0.0%
1
   2.7%
Leukocyte Esterase (No Unit) >=1 Number Analyzed 35 participants 36 participants 39 participants 10 participants 38 participants 37 participants 39 participants 9 participants 37 participants
8
  22.9%
13
  36.1%
11
  28.2%
1
  10.0%
14
  36.8%
7
  18.9%
8
  20.5%
1
  11.1%
9
  24.3%
Urine Erythrocytes (/HPF) >=20 Number Analyzed 22 participants 19 participants 25 participants 6 participants 23 participants 18 participants 25 participants 3 participants 25 participants
1
   4.5%
1
   5.3%
4
  16.0%
1
  16.7%
2
   8.7%
3
  16.7%
5
  20.0%
0
   0.0%
1
   4.0%
Urine Leukocytes (/HPF) >=20 Number Analyzed 25 participants 23 participants 31 participants 9 participants 29 participants 28 participants 29 participants 7 participants 26 participants
0
   0.0%
2
   8.7%
3
   9.7%
1
  11.1%
3
  10.3%
1
   3.6%
1
   3.4%
0
   0.0%
4
  15.4%
Hyaline Casts (/LPF) >1 Number Analyzed 7 participants 1 participants 8 participants 3 participants 9 participants 2 participants 6 participants 1 participants 3 participants
5
  71.4%
0
   0.0%
6
  75.0%
2
  66.7%
4
  44.4%
1
  50.0%
2
  33.3%
1
 100.0%
2
  66.7%
WBC Casts (/LPF) >1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
0 0 0 0 0 0 0 0
1
 100.0%
Bacteria (No Unit) >20 Number Analyzed 10 participants 9 participants 10 participants 5 participants 12 participants 9 participants 10 participants 2 participants 12 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period)
Hide Description An AE was an 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: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs mentioned below are treatment-emergent AEs.
Time Frame From Day 1 up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The participants who received at least one dose of PF-06651600, PF-06700841, or placebo.
Arm/Group Title Placebo (Induction) PF-06651600 20 mg (Induction) PF-06651600 70 mg (Induction) PF-06651600 200 mg (Induction) PF-06700841 10 mg (Induction) PF-06700841 30 mg (Induction) PF-06700841 60 mg (Induction)
Hide Arm/Group Description:
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
Overall Number of Participants Analyzed 25 51 49 50 48 47 47
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with AEs
13
  52.0%
23
  45.1%
21
  42.9%
21
  42.0%
19
  39.6%
26
  55.3%
23
  48.9%
Participants with SAEs
0
   0.0%
3
   5.9%
0
   0.0%
3
   6.0%
1
   2.1%
3
   6.4%
1
   2.1%
Participants discontinued from study due to AEs
0
   0.0%
5
   9.8%
0
   0.0%
5
  10.0%
1
   2.1%
2
   4.3%
1
   2.1%
11.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities (Induction Period)
Hide Description The number of participants with a laboratory abnormality meeting the pre-specified criteria defined in the study protocol while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. Laboratory data included hematology test, serum chemistry test, C-creative protein and viral surveillance. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.
Time Frame From Day 1 up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The participants with at least one observation of the given laboratory test while on study treatment or during lag time.
Arm/Group Title Placebo (Induction) PF-06651600 20 mg (Induction) PF-06651600 70 mg (Induction) PF-06651600 200 mg (Induction) PF-06700841 10 mg (Induction) PF-06700841 30 mg (Induction) PF-06700841 60 mg (Induction)
Hide Arm/Group Description:
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
Overall Number of Participants Analyzed 25 49 48 50 48 47 47
Measure Type: Count of Participants
Unit of Measure: Participants
17
  68.0%
29
  59.2%
28
  58.3%
34
  68.0%
32
  66.7%
31
  66.0%
36
  76.6%
12.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Hide Description The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of hematology test parameters were as follows: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils (absolute, Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs), prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT), and reticulocytes (% and Abs). Percentages are displayed for the laboratory tests having a category with greater or equal to 1 evaluable participant.
Time Frame From Day 1 up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
Arm/Group Title Placebo (Induction) PF-06651600 20 mg (Induction) PF-06651600 70 mg (Induction) PF-06651600 200 mg (Induction) PF-06700841 10 mg (Induction) PF-06700841 30 mg (Induction) PF-06700841 60 mg (Induction)
Hide Arm/Group Description:
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
Overall Number of Participants Analyzed 25 51 49 50 48 47 47
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin (g/dL) <0.8× lower limit of normal (LLN) Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
3
  12.0%
2
   4.1%
5
  10.4%
9
  18.0%
4
   8.3%
4
   8.5%
5
  10.6%
Hematocrit (%) <0.8× LLN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
2
   8.0%
0
   0.0%
3
   6.3%
4
   8.0%
1
   2.1%
1
   2.1%
0
   0.0%
Erythrocytes (10^6/mm^3) <0.8× LLN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
4
   8.3%
3
   6.0%
1
   2.1%
1
   2.1%
2
   4.3%
Reticulocytes (Abs) (10^3/mm^3) <0.5× LLN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 46 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Reticulocytes (Abs) (10^3/mm^3) >1.5× upper limit of normal (ULN) Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 46 participants 47 participants
1
   4.0%
1
   2.0%
2
   4.2%
2
   4.0%
0
   0.0%
0
   0.0%
0
   0.0%
Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 1 participants 1 participants
0 0 0
0
   0.0%
 0
0
   0.0%
0
   0.0%
Erythrocytes Mean Corpuscular Volume (10^-15L) >1.1× ULN Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 1 participants 1 participants
0 0 0
0
   0.0%
 0
0
   0.0%
0
   0.0%
Platelets (10^3/mm^3) <0.5× LLN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets (10^3/mm^3) >1.75× ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
1
   4.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.2%
2
   4.3%
5
  10.6%
Reticulocytes/Erythrocytes (%) <0.5× LLN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 46 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Reticulocytes/Erythrocytes (%) >1.5× ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 46 participants 47 participants
1
   4.0%
2
   4.1%
3
   6.3%
3
   6.0%
0
   0.0%
0
   0.0%
2
   4.3%
Leukocytes (10^3/mm^3) <0.6× LLN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.1%
0
   0.0%
0
   0.0%
Leukocytes (10^3/mm^3) >1.5× ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
3
   6.1%
0
   0.0%
3
   6.0%
2
   4.2%
2
   4.3%
1
   2.1%
Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
3
  12.0%
2
   4.1%
4
   8.3%
11
  22.0%
2
   4.2%
1
   2.1%
2
   4.3%
Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
1
   2.1%
1
   2.1%
1
   2.1%
Neutrophils (Abs) (10^3/mm^3) <0.8× LLN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
1
   4.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.2%
3
   6.4%
2
   4.3%
Neutrophils (Abs) (10^3/mm^3) >1.2× ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
7
  28.0%
13
  26.5%
7
  14.6%
9
  18.0%
7
  14.6%
7
  14.9%
11
  23.4%
Basophils (Abs) (10^3/mm^3) >1.2× ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
1
   2.1%
0
   0.0%
1
   2.1%
1
   2.1%
0
   0.0%
Eosinophils (Abs) (10^3/mm^3) >1.2x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
2
   8.0%
3
   6.1%
1
   2.1%
1
   2.0%
1
   2.1%
3
   6.4%
2
   4.3%
Monocytes (Abs) (10^3/mm^3) >1.2× ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
2
   8.0%
2
   4.1%
0
   0.0%
2
   4.0%
1
   2.1%
1
   2.1%
2
   4.3%
Activated PTT (second) >1.1× ULN Number Analyzed 25 participants 48 participants 48 participants 50 participants 48 participants 47 participants 46 participants
1
   4.0%
0
   0.0%
1
   2.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PT (second) >1.1× ULN Number Analyzed 25 participants 48 participants 48 participants 50 participants 48 participants 47 participants 46 participants
1
   4.0%
2
   4.2%
1
   2.1%
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
Prothrombin INR >1.1× ULN Number Analyzed 25 participants 48 participants 48 participants 50 participants 48 participants 47 participants 46 participants
1
   4.0%
2
   4.2%
1
   2.1%
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Hide Description The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of serum chemistry test parameters were as follows: blood urea nitrogen, creatinine, cystatin C, glucose, calcium, sodium, potassium, gamma glutamyl transferase, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, uric acid, albumin, total protein, creatine kinase (CK), total cholesterol, triglycerides, high-density lipoproteins (HDL), and low-density lipoprotein (LDL)
Time Frame From Day 1 up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
Arm/Group Title Placebo (Induction) PF-06651600 20 mg (Induction) PF-06651600 70 mg (Induction) PF-06651600 200 mg (Induction) PF-06700841 10 mg (Induction) PF-06700841 30 mg (Induction) PF-06700841 60 mg (Induction)
Hide Arm/Group Description:
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
Overall Number of Participants Analyzed 25 51 49 50 48 47 47
Measure Type: Count of Participants
Unit of Measure: Participants
Bilirubin (mg/dL) >1.5x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
1
   2.0%
0
   0.0%
1
   2.0%
2
   4.2%
2
   4.3%
1
   2.1%
Direct Bilirubin (mg/dL) >1.5x ULN Number Analyzed 2 participants 3 participants 2 participants 5 participants 5 participants 4 participants 2 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Indirect Bilirubin (mg/dL) >1.5x ULN Number Analyzed 1 participants 0 participants 1 participants 1 participants 1 participants 1 participants 1 participants
0
   0.0%
 0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST (U/L) >3.0x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT (U/L) >3.0x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.2%
0
   0.0%
0
   0.0%
Gamma Glutamyl Transferase (U/L) >3.0x ULN Number Analyzed 1 participants 0 participants 1 participants 1 participants 1 participants 2 participants 1 participants
0
   0.0%
 0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Alkaline Phosphatase (U/L) >3.0x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Protein (g/dL) <0.8x LLN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Protein (g/dL) >1.2x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Albumin (g/dL) <0.8x LLN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Albumin (g/dL) >1.2x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Urea Nitrogen (mg/dL) >1.3x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine (mg/dL) >1.3x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 47 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.1%
0
   0.0%
Urate (mg/dL) >1.2x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
1
   2.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
HDL Cholesterol (mg/dL) <0.8x LLN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
LDL Cholesterol (mg/dL) >1.2x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
1
   2.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.1%
Triglycerides (mg/dL) >1.3x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
1
   4.0%
1
   2.0%
1
   2.1%
3
   6.0%
1
   2.1%
2
   4.3%
5
  10.6%
Sodium(Meq/L) <0.95x LLN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sodium(Meq/L) >1.05x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium (Meq/L) <0.9x LLN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium (Meq/L) >1.1x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
1
   2.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Chloride (Meq/L) <0.9x LLN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Chloride (Meq/L) >1.1x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Calcium (mg/dL) <0.9x LLN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Calcium (mg/dL) >1.1x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glucose (mg/dL) <0.6x LLN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glucose (mg/dL) >1.5x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
1
   2.0%
2
   4.2%
1
   2.0%
1
   2.1%
0
   0.0%
2
   4.3%
Hemoglobin A1C (%) >1.3x ULN Number Analyzed 0 participants 2 participants 1 participants 1 participants 0 participants 1 participants 2 participants
0
0
   0.0%
0
   0.0%
0
   0.0%
 0
0
   0.0%
0
   0.0%
CK (U/L) >2.0x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
2
   8.0%
0
   0.0%
2
   4.2%
3
   6.0%
2
   4.2%
3
   6.4%
6
  12.8%
Cholesterol (mg/dl) >1.3x ULN Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
1
   2.1%
0
   0.0%
0
   0.0%
1
   2.1%
0
   0.0%
14.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
Hide Description The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of urinalysis test parameters were as follows:pH, glucose (qual), protein (qual), blood (qual), ketones, nitrites, leukocyte esterase, microscopy, and spot urine albumin/creatinine ratio. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.
Time Frame From Day 1 up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
Arm/Group Title Placebo (Induction) PF-06651600 20 mg (Induction) PF-06651600 70 mg (Induction) PF-06651600 200 mg (Induction) PF-06700841 10 mg (Induction) PF-06700841 30 mg (Induction) PF-06700841 60 mg (Induction)
Hide Arm/Group Description:
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
Overall Number of Participants Analyzed 25 51 49 50 48 47 47
Measure Type: Count of Participants
Unit of Measure: Participants
pH (scalar) <4.5 Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
pH (scalar) >8 Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Urine glucose (no unit) ≥1 Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
1
   2.0%
4
   8.3%
1
   2.0%
0
   0.0%
1
   2.1%
1
   2.1%
Ketones (no unit) ≥1 Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
1
   4.0%
4
   8.2%
1
   2.1%
1
   2.0%
7
  14.6%
4
   8.5%
4
   8.5%
Urine protein(no unit) ≥1 Number Analyzed 25 participants 49 participants 48 participants 50 participants 48 participants 47 participants 47 participants
0
   0.0%
2
   4.1%
0
   0.0%