Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether PF-06700841 is safe and effective in the treatment of chronic plaque psoriasis.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: PF-06700841 60 mg followed by 30 mg once daily 4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 30 mg PF-06700841 once daily |
Drug: PF-06700841
|
Experimental: PF-06700841 60 mg followed by 10 mg once daily 4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily |
Drug: PF-06700841
|
Experimental: PF-06700841 60mg once daily followed by 100mg once weekly 4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly |
Drug: PF-06700841
|
Experimental: PF-06700841 60mg once daily followed by placebo once daily 4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of placebo once daily |
Drug: PF-06700841
|
Experimental: PF-06700841 30mg once daily 4 week induction with 30 mg PF-06700841 once daily followed by 8 week chronic administration of 30 mg PF-06700841 once daily |
Drug: PF-06700841
|
Experimental: PF-06700841 30mg once daily followed by 10mg once daily 4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily |
Drug: PF-06700841
|
Experimental: PF-06700841 30mg once daily followed by 100mg once weekly 4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly |
Drug: PF-06700841
|
Placebo Comparator: Placebo 12 weeks once daily placebo |
Other: Placebo
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 [Baseline (Day 1 pre-dose), Week 12]
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.
Secondary Outcome Measures
- Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 [Week 12]
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.
- Change From Baseline in PASI Scores at Week 4 by Induction Dose [Baseline (Day 1 pre-dose), Week 4]
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.
- Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16 [Weeks 1, 2, 4, 6, 8, 10, 14, 16]
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.
- Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 [Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16]
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.
- Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 [Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16]
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.
- Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16 [Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 14, 16]
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.
- Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 [Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16]
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.
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [From first dose of study treatment (Day 1) up to Week 20]
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.
- Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs [From first dose of study treatment (Day 1) up to Week 20]
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).
- Change From Baseline in Blood Lipid Level at Weeks 4 and 12 [Baseline (Day 1 pre-dose), Weeks 4 and 12]
Lipid panel included low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides.
- Number of Participants With Any Post-Baseline Laboratory Test Abnormalities [From first dose of study treatment (Day 1) up to Week 16]
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).
- Number of Participants With Post-Baseline Vital Sign Abnormalities [From first dose of study treatment (Day 1) up to Week 16]
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.
- Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities [From first dose of study treatment (Day 1) up to Week 16]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have had a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline/Day 1 (prior to first dose of study drug)
-
Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline/Day 1 (prior to first dose of study drug)
-
Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at Baseline/Day 1 (prior to first dose of study drug)
-
Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment)
Exclusion Criteria:
-
Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed
-
Have evidence of skin conditions (eg, eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis
-
Cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA)
-
Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz).
-
Have taken Apremilast (Otezla) within 3 months of first dose of study drug.
-
Have undergone treatment with tofacitinib within 3 months of first dose.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA | Rogers | Arkansas | United States | 72758 |
2 | Anaheim Clinical Trials, LLC | Anaheim | California | United States | 92801 |
3 | California Dermatology & Clinical Research Institute | Encinitas | California | United States | 92024 |
4 | Emil A. Tanghetti, MD dba Center for Dermatology and Laser Surgery | Sacramento | California | United States | 95819 |
5 | Southern California Dermatology | Santa Ana | California | United States | 92701 |
6 | Tower Saint John's Imaging | Santa Monica | California | United States | 90403 |
7 | Clinical Science Institute | Santa Monica | California | United States | 90404 |
8 | Park Avenue Dermatology Administrative Annex | Orange Park | Florida | United States | 32073 |
9 | Park Avenue Dermatology | Orange Park | Florida | United States | 32073 |
10 | Olympian Clinical Research | Tampa | Florida | United States | 33609 |
11 | Rose Radiology | Tampa | Florida | United States | 33609 |
12 | Forward Clinical Trials, Inc | Tampa | Florida | United States | 33624 |
13 | Dundee Dermatology | West Dundee | Illinois | United States | 60118 |
14 | Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | United States | 46256 |
15 | Dawes Fretzin Dermatology Group, LLC | Indianapolis | Indiana | United States | 46256 |
16 | Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | United States | 08520 |
17 | The Rockefeller University | New York | New York | United States | 10065 |
18 | Skin Search of Rochester, Inc. | Rochester | New York | United States | 14623 |
19 | Investigational Drug Services, UNC Hospitals | Chapel Hill | North Carolina | United States | 27514 |
20 | UNC Dermatology and Skin Cancer Center | Chapel Hill | North Carolina | United States | 27516 |
21 | UNC Clinical and Translation Research Center | Chapel Hill | North Carolina | United States | 27599 |
22 | Lynn Health Science Institute | Oklahoma City | Oklahoma | United States | 73112 |
23 | Vital Prospects Clinical Research Institute, P.C | Tulsa | Oklahoma | United States | 74136 |
24 | Health Concepts | Rapid City | South Dakota | United States | 57702 |
25 | Center for Clinical Studies | Houston | Texas | United States | 77004 |
26 | Lee Medical Associates, PA | San Antonio | Texas | United States | 78213 |
27 | Progressive Clinical Research, PA | San Antonio | Texas | United States | 78213 |
28 | Texas Dermatology and Laser Specialists | San Antonio | Texas | United States | 78218 |
29 | Virginia Clinical Research, Inc. | Norfolk | Virginia | United States | 23502 |
30 | Premier Clinical Research | Spokane | Washington | United States | 99202 |
31 | Wiseman Dermatology Research Inc. | Winnipeg | Manitoba | Canada | R3M 3Z4 |
32 | Lynderm Research Inc | Markham | Ontario | Canada | L3P 1X2 |
33 | Research by ICLS | Oakville | Ontario | Canada | L6J 7W5 |
34 | Skin Centre for Dermatology | Peterborough | Ontario | Canada | K9J 5K2 |
35 | The Centre for Dermatology | Richmond Hill | Ontario | Canada | L4B 1A5 |
36 | K.Papp Clinical Research Inc. | Waterloo | Ontario | Canada | N2J 1C4 |
37 | Diex Research Sherbrooke Inc. | Sherbrooke | Quebec | Canada | J1L 0H8 |
38 | Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ) | Quebec | Canada | G1V4X7 | |
39 | Centrum Medyczne Enel-Med Przychodnia Grunwaldzka | Gdansk | Poland | 80-266 | |
40 | Centrum Badan Klinicznych PI-House Sp. z o.o. | Gdansk | Poland | 80-546 | |
41 | Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak | Lodz | Poland | 90-436 | |
42 | NZOZ "Nasz Lekarz" - Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna | Torun | Poland | 87-100 | |
43 | MTZ Clinical Research Sp. z o.o. | Warszawa | Poland | 02-106 | |
44 | WroMedica s.c. | Wroclaw | Poland | 51-685 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- B7931004
- 2016-004049-96
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
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 |
---|---|---|---|---|---|---|---|---|
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 |
Baseline Characteristics
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 |
---|---|---|---|---|---|---|---|---|---|
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 Participants | 25 | 29 | 26 | 25 | 29 | 25 | 30 | 23 | 212 |
Age (years) [Mean (Standard Deviation) ] | |||||||||
Mean (Standard Deviation) [years] |
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 (Count of Participants) | |||||||||
18-44 Years |
8
32%
|
14
48.3%
|
10
38.5%
|
8
32%
|
14
48.3%
|
12
48%
|
14
46.7%
|
8
34.8%
|
88
41.5%
|
45-64 Years |
14
56%
|
13
44.8%
|
14
53.8%
|
13
52%
|
14
48.3%
|
13
52%
|
16
53.3%
|
12
52.2%
|
109
51.4%
|
>=65 Years |
3
12%
|
2
6.9%
|
2
7.7%
|
4
16%
|
1
3.4%
|
0
0%
|
0
0%
|
3
13%
|
15
7.1%
|
Sex: Female, Male (Count of Participants) | |||||||||
Female |
9
36%
|
8
27.6%
|
14
53.8%
|
4
16%
|
10
34.5%
|
8
32%
|
7
23.3%
|
4
17.4%
|
64
30.2%
|
Male |
16
64%
|
21
72.4%
|
12
46.2%
|
21
84%
|
19
65.5%
|
17
68%
|
23
76.7%
|
19
82.6%
|
148
69.8%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||||||||
Hispanic or Latino |
4
16%
|
4
13.8%
|
4
15.4%
|
2
8%
|
6
20.7%
|
5
20%
|
4
13.3%
|
4
17.4%
|
33
15.6%
|
Not Hispanic or Latino |
21
84%
|
25
86.2%
|
22
84.6%
|
23
92%
|
23
79.3%
|
20
80%
|
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%
|
Race/Ethnicity, Customized (Count of Participants) | |||||||||
White |
22
88%
|
27
93.1%
|
23
88.5%
|
24
96%
|
27
93.1%
|
22
88%
|
25
83.3%
|
19
82.6%
|
189
89.2%
|
Black or African American |
3
12%
|
0
0%
|
3
11.5%
|
0
0%
|
1
3.4%
|
1
4%
|
1
3.3%
|
2
8.7%
|
11
5.2%
|
Asian |
0
0%
|
1
3.4%
|
0
0%
|
1
4%
|
0
0%
|
0
0%
|
2
6.7%
|
0
0%
|
4
1.9%
|
American Indian or Alaska Native |
0
0%
|
1
3.4%
|
0
0%
|
0
0%
|
0
0%
|
1
4%
|
0
0%
|
1
4.3%
|
3
1.4%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
4%
|
1
3.3%
|
0
0%
|
2
0.9%
|
Other |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.4%
|
0
0%
|
1
3.3%
|
1
4.3%
|
3
1.4%
|
Outcome Measures
Title | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|---|---|---|---|---|
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. |
Measure Participants | 22 | 21 | 21 | 21 | 27 | 19 | 25 | 17 |
Least Squares Mean (90% Confidence Interval) [units on a scale] |
-15.85
|
-10.56
|
-14.28
|
-10.14
|
-17.28
|
-13.27
|
-11.88
|
-7.21
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0005 |
Comments | Hochberg adjusted p-value | |
Method | Mixed Models Analysis | |
Comments | ||
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 |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | PF-06700841 60 mg QD Followed by 10 mg QD, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0963 |
Comments | Hochberg adjusted p-value | |
Method | Mixed Models Analysis | |
Comments | ||
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 |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW), Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0046 |
Comments | Hochberg adjusted p-value | |
Method | Mixed Models Analysis | |
Comments | ||
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 |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | PF-06700841 60 mg QD Followed by Placebo, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0963 |
Comments | Hochberg adjusted p-value | |
Method | Mixed Models Analysis | |
Comments | ||
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 |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | PF-06700841 30 mg QD, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | Hochberg adjusted p-value | |
Method | Mixed Models Analysis | |
Comments | ||
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 |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | PF-06700841 30 mg QD Followed by 10 mg QD, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0158 |
Comments | Hochberg adjusted p-value | |
Method | Mixed Models Analysis | |
Comments | ||
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 |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | PF-06700841 30 mg QD Followed by 100 mg QW, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0488 |
Comments | Hochberg adjusted p-value | |
Method | Mixed Models Analysis | |
Comments | ||
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 |
Title | Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|---|---|---|---|---|
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. |
Measure Participants | 25 | 29 | 26 | 25 | 29 | 25 | 30 | 23 |
Number (90% Confidence Interval) [percentage of participants] |
60.0
240%
|
24.1
83.1%
|
57.7
221.9%
|
24.0
96%
|
86.2
297.2%
|
24.0
96%
|
36.7
122.3%
|
13.0
56.5%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 10.00 | |
Confidence Interval |
(2-Sided) 90% 2.95 to 33.87 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | ||
Other Statistical Analysis | Logistic regression |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | PF-06700841 60 mg QD Followed by 10 mg QD, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 2.12 | |
Confidence Interval |
(2-Sided) 90% 0.61 to 7.36 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | ||
Other Statistical Analysis | Logistic regression |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW), Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 9.09 | |
Confidence Interval |
(2-Sided) 90% 2.71 to 30.48 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | ||
Other Statistical Analysis | Logistic regression |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | PF-06700841 60 mg QD Followed by Placebo, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 2.11 | |
Confidence Interval |
(2-Sided) 90% 0.59 to 7.55 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | ||
Other Statistical Analysis | Logistic regression |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | PF-06700841 30 mg QD, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 41.67 | |
Confidence Interval |
(2-Sided) 90% 10.80 to 160.68 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | ||
Other Statistical Analysis | Logistic regression |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | PF-06700841 30 mg QD Followed by 10 mg QD, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 2.11 | |
Confidence Interval |
(2-Sided) 90% 0.59 to 7.55 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | ||
Other Statistical Analysis | Logistic regression |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | PF-06700841 30 mg QD Followed by 100 mg QW, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 3.86 | |
Confidence Interval |
(2-Sided) 90% 1.17 to 12.74 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | ||
Other Statistical Analysis | Logistic regression |
Title | Change From Baseline in PASI Scores at Week 4 by Induction Dose |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|
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. |
Measure Participants | 100 | 81 | 21 |
Least Squares Mean (90% Confidence Interval) [units on a scale] |
-13.17
|
-12.16
|
-4.17
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD, PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | Mixed Models Analysis | |
Comments | ||
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 |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | PF-06700841 60 mg QD Followed by 10 mg QD, PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | Mixed Models Analysis | |
Comments | ||
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 |
Title | Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16 |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|---|---|---|---|---|
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. |
Measure Participants | 25 | 29 | 26 | 25 | 29 | 25 | 30 | 23 |
Week 1 |
0
0%
|
6.9
23.8%
|
7.7
29.6%
|
4.0
16%
|
0
0%
|
4.0
16%
|
0
0%
|
0
0%
|
Week 2 |
8.0
32%
|
13.8
47.6%
|
26.9
103.5%
|
12.0
48%
|
3.4
11.7%
|
8.0
32%
|
0
0%
|
0
0%
|
Week 4 |
24.0
96%
|
41.4
142.8%
|
61.5
236.5%
|
36.0
144%
|
27.6
95.2%
|
24.0
96%
|
36.7
122.3%
|
0
0%
|
Week 6 |
44.0
176%
|
41.4
142.8%
|
65.4
251.5%
|
36.0
144%
|
51.7
178.3%
|
28.0
112%
|
26.7
89%
|
8.7
37.8%
|
Week 8 |
60.0
240%
|
37.9
130.7%
|
65.4
251.5%
|
32.0
128%
|
65.5
225.9%
|
20.0
80%
|
40.0
133.3%
|
8.7
37.8%
|
Week 10 |
48.0
192%
|
24.1
83.1%
|
61.5
236.5%
|
32.0
128%
|
72.4
249.7%
|
28.0
112%
|
46.7
155.7%
|
13.0
56.5%
|
Week 14 |
48.0
192%
|
17.2
59.3%
|
34.6
133.1%
|
16.0
64%
|
75.9
261.7%
|
16.0
64%
|
16.7
55.7%
|
8.7
37.8%
|
Week 16 |
36.0
144%
|
10.3
35.5%
|
30.8
118.5%
|
20.0
80%
|
58.6
202.1%
|
12.0
48%
|
16.7
55.7%
|
8.7
37.8%
|
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 |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|---|---|---|---|---|
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. |
Measure Participants | 25 | 29 | 26 | 25 | 29 | 25 | 30 | 23 |
Week 1 |
12.0
48%
|
13.8
47.6%
|
19.2
73.8%
|
20.0
80%
|
10.3
35.5%
|
8.0
32%
|
3.3
11%
|
0
0%
|
Week 2 |
44.0
176%
|
37.9
130.7%
|
46.2
177.7%
|
32.0
128%
|
41.4
142.8%
|
20.0
80%
|
33.3
111%
|
0
0%
|
Week 4 |
60.0
240%
|
69.0
237.9%
|
69.2
266.2%
|
68.0
272%
|
69.0
237.9%
|
60.0
240%
|
66.7
222.3%
|
13.0
56.5%
|
Week 6 |
72.0
288%
|
62.1
214.1%
|
73.1
281.2%
|
68.0
272%
|
82.8
285.5%
|
60.0
240%
|
63.3
211%
|
26.1
113.5%
|
Week 8 |
72.0
288%
|
55.2
190.3%
|
73.1
281.2%
|
52.0
208%
|
86.2
297.2%
|
56.0
224%
|
63.3
211%
|
17.4
75.7%
|
Week 10 |
68.0
272%
|
44.8
154.5%
|
73.1
281.2%
|
48.0
192%
|
86.2
297.2%
|
48.0
192%
|
56.7
189%
|
17.4
75.7%
|
Week 12 |
68.0
272%
|
44.8
154.5%
|
69.2
266.2%
|
52.0
208%
|
89.7
309.3%
|
48.0
192%
|
53.3
177.7%
|
21.7
94.3%
|
Week 14 |
64.0
256%
|
44.8
154.5%
|
61.5
236.5%
|
48.0
192%
|
89.7
309.3%
|
36.0
144%
|
36.7
122.3%
|
26.1
113.5%
|
Week 16 |
60.0
240%
|
34.5
119%
|
53.8
206.9%
|
40.0
160%
|
79.3
273.4%
|
40.0
160%
|
36.7
122.3%
|
21.7
94.3%
|
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 |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|---|---|---|---|---|
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. |
Measure Participants | 25 | 29 | 26 | 25 | 29 | 25 | 30 | 23 |
Week 1 |
0
0%
|
3.4
11.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Week 2 |
0
0%
|
3.4
11.7%
|
7.7
29.6%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Week 4 |
12.0
48%
|
20.7
71.4%
|
42.3
162.7%
|
16.0
64%
|
6.9
23.8%
|
8.0
32%
|
3.3
11%
|
0
0%
|
Week 6 |
16.0
64%
|
20.7
71.4%
|
26.9
103.5%
|
12.0
48%
|
24.1
83.1%
|
8.0
32%
|
20.0
66.7%
|
0
0%
|
Week 8 |
24.0
96%
|
17.2
59.3%
|
30.8
118.5%
|
8.0
32%
|
34.5
119%
|
4.0
16%
|
16.7
55.7%
|
0
0%
|
Week 10 |
28.0
112%
|
17.2
59.3%
|
26.9
103.5%
|
8.0
32%
|
34.5
119%
|
8.0
32%
|
13.3
44.3%
|
4.3
18.7%
|
Week 12 |
36.0
144%
|
13.8
47.6%
|
26.9
103.5%
|
8.0
32%
|
51.7
178.3%
|
8.0
32%
|
10.0
33.3%
|
4.3
18.7%
|
Week 14 |
28.0
112%
|
13.8
47.6%
|
11.5
44.2%
|
8.0
32%
|
37.9
130.7%
|
4.0
16%
|
13.3
44.3%
|
4.3
18.7%
|
Week 16 |
20.0
80%
|
3.4
11.7%
|
15.4
59.2%
|
4.0
16%
|
27.6
95.2%
|
8.0
32%
|
10.0
33.3%
|
4.3
18.7%
|
Title | Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16 |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|---|---|---|---|---|
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. |
Measure Participants | 25 | 29 | 26 | 25 | 29 | 25 | 30 | 23 |
Week 1 |
-5.74
|
-4.60
|
-5.85
|
-5.37
|
-3.97
|
-4.41
|
-3.46
|
-1.35
|
Week 2 |
-9.44
|
-8.35
|
-10.79
|
-9.49
|
-7.86
|
-7.79
|
-7.93
|
-2.28
|
Week 4 |
-12.85
|
-12.19
|
-14.11
|
-13.91
|
-11.72
|
-12.88
|
-13.06
|
-4.02
|
Week 6 |
-15.00
|
-12.12
|
-15.00
|
-13.85
|
-14.30
|
-14.33
|
-14.17
|
-5.52
|
Week 8 |
-15.94
|
-11.09
|
-14.97
|
-12.87
|
-15.82
|
-14.27
|
-13.83
|
-6.56
|
Week 10 |
-16.54
|
-9.89
|
-15.52
|
-11.64
|
-16.65
|
-14.98
|
-12.97
|
-6.78
|
Week 14 |
-15.47
|
-8.11
|
-13.31
|
-9.45
|
-16.14
|
-10.44
|
-11.03
|
-6.98
|
Week 16 |
-14.16
|
-6.59
|
-13.00
|
-7.83
|
-14.38
|
-9.62
|
-9.13
|
-6.76
|
Title | Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|---|---|---|---|---|
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. |
Measure Participants | 25 | 29 | 26 | 25 | 29 | 25 | 30 | 23 |
Week 1 |
-26.70
|
-24.66
|
-30.25
|
-23.33
|
-20.92
|
-17.50
|
-15.42
|
-6.90
|
Week 2 |
-43.66
|
-44.17
|
-54.27
|
-42.58
|
-40.89
|
-32.46
|
-35.89
|
-12.81
|
Week 4 |
-57.16
|
-63.02
|
-72.41
|
-64.71
|
-60.76
|
-53.93
|
-58.99
|
-25.17
|
Week 6 |
-66.07
|
-63.31
|
-75.96
|
-65.06
|
-73.91
|
-58.57
|
-63.17
|
-33.49
|
Week 8 |
-70.11
|
-62.25
|
-77.05
|
-59.88
|
-81.04
|
-58.32
|
-61.38
|
-37.76
|
Week 10 |
-70.72
|
-57.55
|
-78.46
|
-53.81
|
-84.82
|
-61.23
|
-57.24
|
-39.68
|
Week 12 |
-71.94
|
-58.52
|
-74.42
|
-51.49
|
-88.68
|
-57.81
|
-58.57
|
-40.27
|
Week 14 |
-64.15
|
-47.87
|
-63.20
|
-44.30
|
-83.39
|
-47.84
|
-47.52
|
-39.48
|
Week 16 |
-57.28
|
-38.48
|
-60.56
|
-36.63
|
-74.18
|
-44.58
|
-42.29
|
-38.79
|
Title | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|---|---|---|---|---|
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. |
Measure Participants | 25 | 29 | 26 | 25 | 29 | 25 | 30 | 23 |
Treatment-emergent AEs |
19
76%
|
21
72.4%
|
18
69.2%
|
18
72%
|
21
72.4%
|
16
64%
|
23
76.7%
|
13
56.5%
|
Treatment-emergent SAEs |
2
8%
|
1
3.4%
|
1
3.8%
|
1
4%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|---|---|---|---|---|
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. |
Measure Participants | 25 | 29 | 26 | 25 | 29 | 25 | 30 | 23 |
Count of Participants [Participants] |
2
8%
|
4
13.8%
|
1
3.8%
|
2
8%
|
0
0%
|
2
8%
|
2
6.7%
|
0
0%
|
Title | Change From Baseline in Blood Lipid Level at Weeks 4 and 12 |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|---|---|---|---|---|
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. |
Measure Participants | 25 | 29 | 26 | 25 | 29 | 25 | 30 | 23 |
LDL Cholesterol, Week 4 |
15.91
|
11.27
|
15.00
|
15.88
|
8.96
|
-2.21
|
7.60
|
-6.28
|
LDL Cholesterol, Week 12 |
8.71
|
6.00
|
-0.74
|
6.85
|
14.10
|
-5.33
|
3.95
|
-4.00
|
HDL Cholesterol, Week 4 |
12.09
|
9.14
|
10.92
|
8.58
|
6.36
|
6.76
|
9.39
|
0.00
|
HDL Cholesterol, Week 12 |
5.00
|
5.48
|
2.48
|
-0.24
|
4.74
|
4.37
|
2.88
|
-2.73
|
Total Cholesterol, Week 4 |
34.39
|
29.46
|
31.32
|
26.33
|
15.14
|
10.36
|
14.00
|
-4.42
|
Total Cholesterol, Week 12 |
19.50
|
15.67
|
-1.86
|
7.05
|
20.37
|
0.68
|
4.33
|
-6.40
|
Triglycerides, Week 4 |
34.74
|
29.68
|
8.04
|
8.92
|
-65.11
|
19.60
|
-59.75
|
15.26
|
Triglycerides, Week 12 |
27.86
|
48.33
|
-85.00
|
2.67
|
-18.96
|
6.32
|
-67.79
|
1.87
|
Title | Number of Participants With Any Post-Baseline Laboratory Test Abnormalities |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|---|---|---|---|---|
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. |
Measure Participants | 25 | 29 | 25 | 25 | 28 | 25 | 30 | 23 |
Count of Participants [Participants] |
17
68%
|
20
69%
|
20
76.9%
|
16
64%
|
21
72.4%
|
20
80%
|
18
60%
|
11
47.8%
|
Title | Number of Participants With Post-Baseline Vital Sign Abnormalities |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|---|---|---|---|---|
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. |
Measure Participants | 25 | 29 | 25 | 25 | 28 | 25 | 30 | 23 |
Sitting DBP <50 mm Hg |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Sitting DBP increase >=20 mm Hg |
1
4%
|
1
3.4%
|
3
11.5%
|
2
8%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Sitting DBP decrease >=20 mm Hg |
3
12%
|
0
0%
|
2
7.7%
|
2
8%
|
1
3.4%
|
2
8%
|
2
6.7%
|
1
4.3%
|
Sitting SBP <90 mm Hg |
1
4%
|
1
3.4%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Sitting SBP increase >=30 mm Hg |
1
4%
|
3
10.3%
|
2
7.7%
|
1
4%
|
0
0%
|
1
4%
|
0
0%
|
0
0%
|
Sitting SBP decrease >=30 mm Hg |
2
8%
|
2
6.9%
|
1
3.8%
|
2
8%
|
1
3.4%
|
3
12%
|
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%
|
Sitting pulse rate >120 bpm |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
4%
|
0
0%
|
0
0%
|
Title | Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|---|---|---|---|---|
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. |
Measure Participants | 24 | 29 | 25 | 25 | 28 | 25 | 28 | 22 |
PR interval >=300 msec |
0
0%
|
0
0%
|
1
3.8%
|
0
0%
|
1
3.4%
|
0
0%
|
0
0%
|
0
0%
|
%Change in PR interval >=25/50% |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
4%
|
0
0%
|
0
0%
|
QRS duration >=140 msec |
0
0%
|
1
3.4%
|
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%
|
1
3.3%
|
0
0%
|
QT interval >=500 msec |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
QTc >=450 to <480 msec |
6
24%
|
1
3.4%
|
2
7.7%
|
0
0%
|
1
3.4%
|
1
4%
|
0
0%
|
1
4.3%
|
QTc >=480 to <500 msec |
0
0%
|
0
0%
|
1
3.8%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
4.3%
|
QTc >=500 msec |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
QTc change >=30 to <60 msec |
2
8%
|
0
0%
|
2
7.7%
|
1
4%
|
3
10.3%
|
3
12%
|
0
0%
|
1
4.3%
|
QTc change >=60 msec |
0
0%
|
0
0%
|
2
7.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
4.3%
|
Adverse Events
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 | ||||||||
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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/25 (4%) | 0/29 (0%) | 0/26 (0%) | 0/25 (0%) | 0/29 (0%) | 0/25 (0%) | 0/30 (0%) | 0/23 (0%) | ||||||||
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%) | 1/29 (3.4%) | 1/26 (3.8%) | 1/25 (4%) | 0/29 (0%) | 0/25 (0%) | 0/30 (0%) | 0/23 (0%) | ||||||||
Blood and lymphatic system disorders | ||||||||||||||||
Anaemia | 0/25 (0%) | 0 | 1/29 (3.4%) | 1 | 0/26 (0%) | 0 | 0/25 (0%) | 0 | 0/29 (0%) | 0 | 0/25 (0%) | 0 | 0/30 (0%) | 0 | 0/23 (0%) | 0 |
Cardiac disorders | ||||||||||||||||
Angina pectoris | 1/25 (4%) | 1 | 0/29 (0%) | 0 | 0/26 (0%) | 0 | 0/25 (0%) | 0 | 0/29 (0%) | 0 | 0/25 (0%) | 0 | 0/30 (0%) | 0 | 0/23 (0%) | 0 |
General disorders | ||||||||||||||||
Chest pain | 0/25 (0%) | 0 | 0/29 (0%) | 0 | 0/26 (0%) | 0 | 1/25 (4%) | 1 | 0/29 (0%) | 0 | 0/25 (0%) | 0 | 0/30 (0%) | 0 | 0/23 (0%) | 0 |
Infections and infestations | ||||||||||||||||
Pneumonia | 0/25 (0%) | 0 | 0/29 (0%) | 0 | 1/26 (3.8%) | 1 | 0/25 (0%) | 0 | 0/29 (0%) | 0 | 0/25 (0%) | 0 | 0/30 (0%) | 0 | 0/23 (0%) | 0 |
Sepsis | 0/25 (0%) | 0 | 0/29 (0%) | 0 | 1/26 (3.8%) | 1 | 0/25 (0%) | 0 | 0/29 (0%) | 0 | 0/25 (0%) | 0 | 0/30 (0%) | 0 | 0/23 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||||||||||||
Gun shot wound | 1/25 (4%) | 1 | 0/29 (0%) | 0 | 0/26 (0%) | 0 | 0/25 (0%) | 0 | 0/29 (0%) | 0 | 0/25 (0%) | 0 | 0/30 (0%) | 0 | 0/23 (0%) | 0 |
Other (Not Including 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 | 11/25 (44%) | 14/29 (48.3%) | 13/26 (50%) | 13/25 (52%) | 13/29 (44.8%) | 12/25 (48%) | 16/30 (53.3%) | 9/23 (39.1%) | ||||||||
Gastrointestinal disorders | ||||||||||||||||
Diarrhoea | 0/25 (0%) | 0 | 1/29 (3.4%) | 1 | 0/26 (0%) | 0 | 1/25 (4%) | 1 | 0/29 (0%) | 0 | 1/25 (4%) | 1 | 3/30 (10%) | 4 | 1/23 (4.3%) | 1 |
Nausea | 1/25 (4%) | 1 | 1/29 (3.4%) | 1 | 1/26 (3.8%) | 1 | 2/25 (8%) | 2 | 0/29 (0%) | 0 | 0/25 (0%) | 0 | 1/30 (3.3%) | 1 | 2/23 (8.7%) | 2 |
Cheilitis | 0/25 (0%) | 0 | 0/29 (0%) | 0 | 0/26 (0%) | 0 | 0/25 (0%) | 0 | 2/29 (6.9%) | 2 | 0/25 (0%) | 0 | 0/30 (0%) | 0 | 0/23 (0%) | 0 |
Vomiting | 0/25 (0%) | 0 | 1/29 (3.4%) | 1 | 1/26 (3.8%) | 1 | 1/25 (4%) | 1 | 0/29 (0%) | 0 | 2/25 (8%) | 2 | 0/30 (0%) | 0 | 0/23 (0%) | 0 |
General disorders | ||||||||||||||||
Fatigue | 1/25 (4%) | 1 | 1/29 (3.4%) | 1 | 1/26 (3.8%) | 1 | 2/25 (8%) | 2 | 0/29 (0%) | 0 | 1/25 (4%) | 1 | 0/30 (0%) | 0 | 1/23 (4.3%) | 1 |
Infections and infestations | ||||||||||||||||
Upper respiratory tract infection | 2/25 (8%) | 2 | 1/29 (3.4%) | 1 | 5/26 (19.2%) | 5 | 1/25 (4%) | 1 | 2/29 (6.9%) | 2 | 0/25 (0%) | 0 | 3/30 (10%) | 3 | 1/23 (4.3%) | 1 |
Bronchitis | 0/25 (0%) | 0 | 2/29 (6.9%) | 2 | 0/26 (0%) | 0 | 0/25 (0%) | 0 | 2/29 (6.9%) | 2 | 0/25 (0%) | 0 | 0/30 (0%) | 0 | 0/23 (0%) | 0 |
Nasopharyngitis | 4/25 (16%) | 4 | 3/29 (10.3%) | 4 | 3/26 (11.5%) | 3 | 3/25 (12%) | 3 | 5/29 (17.2%) | 6 | 6/25 (24%) | 6 | 4/30 (13.3%) | 5 | 3/23 (13%) | 3 |
Sinusitis | 1/25 (4%) | 1 | 0/29 (0%) | 0 | 1/26 (3.8%) | 2 | 2/25 (8%) | 2 | 0/29 (0%) | 0 | 0/25 (0%) | 0 | 1/30 (3.3%) | 1 | 0/23 (0%) | 0 |
Urinary tract infection | 0/25 (0%) | 0 | 1/29 (3.4%) | 1 | 1/26 (3.8%) | 1 | 0/25 (0%) | 0 | 0/29 (0%) | 0 | 1/25 (4%) | 1 | 2/30 (6.7%) | 2 | 0/23 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||||||||||||
Ligament sprain | 0/25 (0%) | 0 | 1/29 (3.4%) | 1 | 0/26 (0%) | 0 | 0/25 (0%) | 0 | 0/29 (0%) | 0 | 2/25 (8%) | 2 | 0/30 (0%) | 0 | 0/23 (0%) | 0 |
Investigations | ||||||||||||||||
Neutrophil count decreased | 0/25 (0%) | 0 | 0/29 (0%) | 0 | 1/26 (3.8%) | 1 | 0/25 (0%) | 0 | 2/29 (6.9%) | 2 | 0/25 (0%) | 0 | 1/30 (3.3%) | 1 | 0/23 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||||||||||||
Back pain | 1/25 (4%) | 1 | 2/29 (6.9%) | 2 | 0/26 (0%) | 0 | 0/25 (0%) | 0 | 2/29 (6.9%) | 2 | 2/25 (8%) | 2 | 1/30 (3.3%) | 2 | 2/23 (8.7%) | 2 |
Arthralgia | 1/25 (4%) | 3 | 2/29 (6.9%) | 2 | 0/26 (0%) | 0 | 0/25 (0%) | 0 | 1/29 (3.4%) | 1 | 1/25 (4%) | 1 | 1/30 (3.3%) | 1 | 1/23 (4.3%) | 1 |
Nervous system disorders | ||||||||||||||||
Headache | 1/25 (4%) | 1 | 2/29 (6.9%) | 2 | 3/26 (11.5%) | 3 | 3/25 (12%) | 3 | 4/29 (13.8%) | 6 | 1/25 (4%) | 1 | 0/30 (0%) | 0 | 1/23 (4.3%) | 1 |
Psychiatric disorders | ||||||||||||||||
Irritability | 0/25 (0%) | 0 | 0/29 (0%) | 0 | 0/26 (0%) | 0 | 2/25 (8%) | 2 | 0/29 (0%) | 0 | 0/25 (0%) | 0 | 0/30 (0%) | 0 | 0/23 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
Oropharyngeal pain | 0/25 (0%) | 0 | 0/29 (0%) | 0 | 1/26 (3.8%) | 1 | 0/25 (0%) | 0 | 2/29 (6.9%) | 2 | 0/25 (0%) | 0 | 0/30 (0%) | 0 | 0/23 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||||||||||||||
Psoriasis | 0/25 (0%) | 0 | 1/29 (3.4%) | 1 | 3/26 (11.5%) | 3 | 1/25 (4%) | 1 | 0/29 (0%) | 0 | 2/25 (8%) | 2 | 0/30 (0%) | 0 | 0/23 (0%) | 0 |
Pruritus | 0/25 (0%) | 0 | 0/29 (0%) | 0 | 1/26 (3.8%) | 1 | 3/25 (12%) | 4 | 1/29 (3.4%) | 1 | 0/25 (0%) | 0 | 1/30 (3.3%) | 2 | 0/23 (0%) | 0 |
Acne | 0/25 (0%) | 0 | 2/29 (6.9%) | 2 | 0/26 (0%) | 0 | 2/25 (8%) | 2 | 0/29 (0%) | 0 | 0/25 (0%) | 0 | 2/30 (6.7%) | 2 | 0/23 (0%) | 0 |
Vascular disorders | ||||||||||||||||
Hot flush | 0/25 (0%) | 0 | 0/29 (0%) | 0 | 0/26 (0%) | 0 | 2/25 (8%) | 2 | 0/29 (0%) | 0 | 0/25 (0%) | 0 | 0/30 (0%) | 0 | 0/23 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Name/Title | Pfizer ClinicalTrials.gov Call Center |
---|---|
Organization | Pfizer, Inc. |
Phone | 1-800-718-1021 |
ClinicalTrials.gov_Inquiries@pfizer.com |
- B7931004
- 2016-004049-96