Trial Outcomes & Findings for Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis (NCT NCT03850483)
NCT ID: NCT03850483
Last Updated: 2022-06-29
Results Overview
The Psoriasis Area and Severity Index (PASI) score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected body surface area (BSA) from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
344 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2022-06-29
Participant Flow
Participant milestones
| Measure |
Stage 1: Vehicle Once Daily (QD)
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 1: PF-06700841 0.1% QD
During stage 1 of the study participants topically applied PF-06700841 0.1 percent (%) cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 1: PF-06700841 0.3% QD
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 1: PF-06700841 1.0% QD
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 1: PF-06700841 3.0% QD
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 1: Vehicle Twice Daily (BID)
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 1: PF-06700841 0.3% BID
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 1: PF-06700841 1.0% BID
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 2: Vehicle BID
During stage 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 2: PF-06700841 3.0% BID
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment for Stage 1
STARTED
|
37
|
37
|
37
|
36
|
37
|
38
|
36
|
36
|
0
|
0
|
|
Treatment for Stage 1
Treated
|
37
|
37
|
37
|
36
|
37
|
37
|
36
|
36
|
0
|
0
|
|
Treatment for Stage 1
COMPLETED
|
29
|
29
|
26
|
30
|
28
|
27
|
25
|
30
|
0
|
0
|
|
Treatment for Stage 1
NOT COMPLETED
|
8
|
8
|
11
|
6
|
9
|
11
|
11
|
6
|
0
|
0
|
|
Follow-up for Stage 1
STARTED
|
37
|
37
|
37
|
36
|
37
|
37
|
36
|
36
|
0
|
0
|
|
Follow-up for Stage 1
COMPLETED
|
37
|
34
|
35
|
34
|
34
|
33
|
34
|
33
|
0
|
0
|
|
Follow-up for Stage 1
NOT COMPLETED
|
0
|
3
|
2
|
2
|
3
|
4
|
2
|
3
|
0
|
0
|
|
Treatment for Stage 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
38
|
|
Treatment for Stage 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
27
|
|
Treatment for Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
11
|
|
Follow-up For Stage 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
38
|
|
Follow-up For Stage 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
36
|
|
Follow-up For Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Stage 1: Vehicle Once Daily (QD)
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 1: PF-06700841 0.1% QD
During stage 1 of the study participants topically applied PF-06700841 0.1 percent (%) cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 1: PF-06700841 0.3% QD
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 1: PF-06700841 1.0% QD
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 1: PF-06700841 3.0% QD
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 1: Vehicle Twice Daily (BID)
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 1: PF-06700841 0.3% BID
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 1: PF-06700841 1.0% BID
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 2: Vehicle BID
During stage 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Stage 2: PF-06700841 3.0% BID
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment for Stage 1
Adverse Event
|
1
|
1
|
3
|
0
|
2
|
0
|
2
|
2
|
0
|
0
|
|
Treatment for Stage 1
Withdrawal by Subject
|
4
|
4
|
2
|
2
|
2
|
1
|
2
|
3
|
0
|
0
|
|
Treatment for Stage 1
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment for Stage 1
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment for Stage 1
Other
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Treatment for Stage 1
Non-Compliance With Study Drug
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment for Stage 1
No Longer Met Eligibility Criteria
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment for Stage 1
Lost to Follow-up
|
0
|
1
|
1
|
1
|
0
|
1
|
2
|
0
|
0
|
0
|
|
Treatment for Stage 1
Lack of Efficacy
|
1
|
2
|
2
|
3
|
2
|
4
|
3
|
1
|
0
|
0
|
|
Treatment for Stage 1
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment for Stage 1
Refused Further Treatment
|
1
|
0
|
2
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Treatment for Stage 1
Randomized but not Treated
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Follow-up for Stage 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
|
Follow-up for Stage 1
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Follow-up for Stage 1
Lack of Efficacy
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Follow-up for Stage 1
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Follow-up for Stage 1
Refused Further Study Procedures
|
0
|
1
|
0
|
0
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Follow-up for Stage 1
Other
|
0
|
2
|
0
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment for Stage 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment for Stage 2
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment for Stage 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Treatment for Stage 2
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment for Stage 2
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment for Stage 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
5
|
|
Treatment for Stage 2
No Longer Meets Eligibility Criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment for Stage 2
Refused Further Treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Follow-up For Stage 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Follow-up For Stage 2
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis
Baseline characteristics by cohort
| Measure |
Vehicle Once Daily (QD)
n=37 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=49 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=38 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Total
n=343 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.6 Years
STANDARD_DEVIATION 15.83 • n=5 Participants
|
51.8 Years
STANDARD_DEVIATION 12.49 • n=7 Participants
|
51.4 Years
STANDARD_DEVIATION 12.26 • n=5 Participants
|
49.4 Years
STANDARD_DEVIATION 15.30 • n=4 Participants
|
48.4 Years
STANDARD_DEVIATION 12.37 • n=21 Participants
|
50.9 Years
STANDARD_DEVIATION 12.85 • n=10 Participants
|
48.2 Years
STANDARD_DEVIATION 13.58 • n=115 Participants
|
50.9 Years
STANDARD_DEVIATION 16.45 • n=24 Participants
|
48.9 Years
STANDARD_DEVIATION 12.93 • n=42 Participants
|
49.9 Years
STANDARD_DEVIATION 13.72 • n=42 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
11 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
102 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
31 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
25 Participants
n=24 Participants
|
24 Participants
n=42 Participants
|
241 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
35 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
39 Participants
n=10 Participants
|
33 Participants
n=115 Participants
|
33 Participants
n=24 Participants
|
31 Participants
n=42 Participants
|
306 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
45 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
31 Participants
n=24 Participants
|
34 Participants
n=42 Participants
|
293 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Efficacy analysis set (EAS) included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic.
The Psoriasis Area and Severity Index (PASI) score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected body surface area (BSA) from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=36 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=49 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=38 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
|
-1.6 Unit on a scale
Standard Error 0.46
|
-2.2 Unit on a scale
Standard Error 0.46
|
-1.4 Unit on a scale
Standard Error 0.46
|
-2.2 Unit on a scale
Standard Error 0.46
|
-2.4 Unit on a scale
Standard Error 0.45
|
-2.2 Unit on a scale
Standard Error 0.42
|
-2.5 Unit on a scale
Standard Error 0.53
|
-3.0 Unit on a scale
Standard Error 0.51
|
-2.8 Unit on a scale
Standard Error 0.48
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category. Scale for PGA: 0= clear, 1= almost clear, 2= mild, 3= moderate and 4= severe. Higher scores indicate more severity.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=29 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=29 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=26 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=29 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=28 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=34 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=24 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=29 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=28 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12
|
6.9 Percentage of participants
Interval 1.8 to 20.0
|
10.3 Percentage of participants
Interval 3.9 to 22.9
|
15.4 Percentage of participants
Interval 6.9 to 29.9
|
10.3 Percentage of participants
Interval 3.9 to 22.9
|
21.4 Percentage of participants
Interval 9.8 to 36.6
|
14.7 Percentage of participants
Interval 7.3 to 26.9
|
20.8 Percentage of participants
Interval 10.5 to 37.0
|
27.6 Percentage of participants
Interval 14.5 to 42.5
|
17.9 Percentage of participants
Interval 8.9 to 33.3
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, and 16Population: EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points.
The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=32 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=34 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=45 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=34 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=37 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 1
|
3.1 Percentage of participants
Interval 0.3 to 13.1
|
3.0 Percentage of participants
Interval 0.3 to 12.7
|
0 Percentage of participants
Interval 0.0 to 8.0
|
0 Percentage of participants
Interval 0.0 to 7.7
|
0 Percentage of participants
Interval 0.0 to 7.7
|
0 Percentage of participants
Interval 0.0 to 6.0
|
0 Percentage of participants
Interval 0.0 to 8.5
|
2.9 Percentage of participants
Interval 0.3 to 12.3
|
2.7 Percentage of participants
Interval 0.3 to 11.2
|
|
Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 2
|
3.1 Percentage of participants
Interval 0.3 to 13.1
|
0 Percentage of participants
Interval 0.0 to 7.5
|
0 Percentage of participants
Interval 0.0 to 8.8
|
2.9 Percentage of participants
Interval 0.3 to 11.9
|
0 Percentage of participants
Interval 0.0 to 7.7
|
2.2 Percentage of participants
Interval 0.2 to 9.2
|
0 Percentage of participants
Interval 0.0 to 7.7
|
6.3 Percentage of participants
Interval 1.7 to 18.0
|
5.7 Percentage of participants
Interval 1.5 to 16.4
|
|
Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
week 4
|
3.1 Percentage of participants
Interval 0.3 to 13.1
|
0 Percentage of participants
Interval 0.0 to 8.5
|
3.6 Percentage of participants
Interval 0.4 to 15.1
|
0 Percentage of participants
Interval 0.0 to 8.0
|
0 Percentage of participants
Interval 0.0 to 8.0
|
8.9 Percentage of participants
Interval 3.9 to 18.0
|
6.7 Percentage of participants
Interval 1.8 to 19.3
|
3.0 Percentage of participants
Interval 0.3 to 12.7
|
12.1 Percentage of participants
Interval 5.4 to 25.1
|
|
Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 6
|
3.2 Percentage of participants
Interval 0.3 to 13.5
|
0 Percentage of participants
Interval 0.0 to 8.8
|
7.4 Percentage of participants
Interval 2.0 to 20.4
|
6.5 Percentage of participants
Interval 1.7 to 18.7
|
10.3 Percentage of participants
Interval 3.9 to 22.9
|
13.9 Percentage of participants
Interval 6.9 to 25.4
|
10.7 Percentage of participants
Interval 4.0 to 23.8
|
10.7 Percentage of participants
Interval 4.0 to 23.8
|
10.3 Percentage of participants
Interval 3.9 to 22.9
|
|
Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 8
|
6.7 Percentage of participants
Interval 1.8 to 19.3
|
6.7 Percentage of participants
Interval 1.8 to 19.3
|
7.4 Percentage of participants
Interval 2.0 to 20.4
|
6.5 Percentage of participants
Interval 1.7 to 18.7
|
14.3 Percentage of participants
Interval 6.4 to 28.4
|
13.9 Percentage of participants
Interval 6.9 to 25.4
|
16.0 Percentage of participants
Interval 7.2 to 30.7
|
13.8 Percentage of participants
Interval 6.2 to 27.9
|
14.3 Percentage of participants
Interval 6.4 to 28.4
|
|
Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 10
|
10.3 Percentage of participants
Interval 3.9 to 22.9
|
3.3 Percentage of participants
Interval 0.4 to 14.0
|
8.0 Percentage of participants
Interval 2.1 to 21.4
|
17.2 Percentage of participants
Interval 8.6 to 32.0
|
14.3 Percentage of participants
Interval 6.4 to 28.4
|
18.2 Percentage of participants
Interval 8.2 to 31.3
|
20.8 Percentage of participants
Interval 10.5 to 37.0
|
10.7 Percentage of participants
Interval 4.0 to 23.8
|
15.4 Percentage of participants
Interval 6.9 to 29.9
|
|
Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 12
|
10.3 Percentage of participants
Interval 3.9 to 22.9
|
10.3 Percentage of participants
Interval 3.9 to 22.9
|
7.7 Percentage of participants
Interval 2.1 to 20.9
|
20.7 Percentage of participants
Interval 9.4 to 35.2
|
17.9 Percentage of participants
Interval 8.9 to 33.3
|
20.6 Percentage of participants
Interval 11.3 to 34.9
|
12.5 Percentage of participants
Interval 4.7 to 28.2
|
24.1 Percentage of participants
Interval 13.4 to 38.5
|
17.9 Percentage of participants
Interval 8.9 to 33.3
|
|
Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 14
|
3.4 Percentage of participants
Interval 0.4 to 14.5
|
7.7 Percentage of participants
Interval 2.1 to 20.9
|
8.7 Percentage of participants
Interval 2.3 to 22.8
|
21.4 Percentage of participants
Interval 9.8 to 36.6
|
14.3 Percentage of participants
Interval 6.4 to 28.4
|
10.3 Percentage of participants
Interval 3.9 to 22.9
|
13.0 Percentage of participants
Interval 4.9 to 29.6
|
20.0 Percentage of participants
Interval 10.1 to 36.2
|
14.8 Percentage of participants
Interval 6.6 to 29.1
|
|
Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 16
|
3.4 Percentage of participants
Interval 0.4 to 14.5
|
11.1 Percentage of participants
Interval 4.2 to 24.8
|
17.4 Percentage of participants
Interval 7.8 to 33.5
|
25.0 Percentage of participants
Interval 13.9 to 40.0
|
15.4 Percentage of participants
Interval 6.9 to 29.9
|
16.1 Percentage of participants
Interval 8.1 to 29.7
|
13.0 Percentage of participants
Interval 4.9 to 29.6
|
12.5 Percentage of participants
Interval 4.7 to 28.2
|
15.4 Percentage of participants
Interval 6.9 to 29.9
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 10 and 12Population: EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points.
The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=32 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=34 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=45 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=34 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=37 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 1
|
-0.9 Unit on a scale
Standard Error 0.22
|
-0.7 Unit on a scale
Standard Error 0.22
|
-0.6 Unit on a scale
Standard Error 0.22
|
-0.9 Unit on a scale
Standard Error 0.22
|
-0.8 Unit on a scale
Standard Error 0.22
|
-0.5 Unit on a scale
Standard Error 0.19
|
-0.7 Unit on a scale
Standard Error 0.23
|
-0.7 Unit on a scale
Standard Error 0.22
|
-0.8 Unit on a scale
Standard Error 0.22
|
|
Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 2
|
-1.4 Unit on a scale
Standard Error 0.26
|
-0.7 Unit on a scale
Standard Error 0.26
|
-0.9 Unit on a scale
Standard Error 0.27
|
-1.4 Unit on a scale
Standard Error 0.26
|
-1.3 Unit on a scale
Standard Error 0.26
|
-0.8 Unit on a scale
Standard Error 0.25
|
-1.4 Unit on a scale
Standard Error 0.29
|
-1.6 Unit on a scale
Standard Error 0.29
|
-1.7 Unit on a scale
Standard Error 0.29
|
|
Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 4
|
-1.4 Unit on a scale
Standard Error 0.31
|
-1.2 Unit on a scale
Standard Error 0.31
|
-1.2 Unit on a scale
Standard Error 0.33
|
-1.4 Unit on a scale
Standard Error 0.31
|
-1.6 Unit on a scale
Standard Error 0.31
|
-1.0 Unit on a scale
Standard Error 0.35
|
-2.3 Unit on a scale
Standard Error 0.42
|
-1.7 Unit on a scale
Standard Error 0.41
|
-2.2 Unit on a scale
Standard Error 0.41
|
|
Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 6
|
-1.5 Unit on a scale
Standard Error 0.35
|
-1.4 Unit on a scale
Standard Error 0.35
|
-1.2 Unit on a scale
Standard Error 0.37
|
-1.6 Unit on a scale
Standard Error 0.35
|
-2.4 Unit on a scale
Standard Error 0.36
|
-1.2 Unit on a scale
Standard Error 0.37
|
-2.5 Unit on a scale
Standard Error 0.45
|
-2.1 Unit on a scale
Standard Error 0.44
|
-2.1 Unit on a scale
Standard Error 0.43
|
|
Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 8
|
-1.6 Unit on a scale
Standard Error 0.39
|
-1.9 Unit on a scale
Standard Error 0.39
|
-0.9 Unit on a scale
Standard Error 0.41
|
-2.1 Unit on a scale
Standard Error 0.39
|
-2.3 Unit on a scale
Standard Error 0.40
|
-1.3 Unit on a scale
Standard Error 0.42
|
-2.4 Unit on a scale
Standard Error 0.50
|
-2.3 Unit on a scale
Standard Error 0.48
|
-2.5 Unit on a scale
Standard Error 0.48
|
|
Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 10
|
-1.6 Unit on a scale
Standard Error 0.41
|
-2.1 Unit on a scale
Standard Error 0.40
|
-1.6 Unit on a scale
Standard Error 0.42
|
-2.3 Unit on a scale
Standard Error 0.40
|
-2.4 Unit on a scale
Standard Error 0.41
|
-1.1 Unit on a scale
Standard Error 0.46
|
-2.4 Unit on a scale
Standard Error 0.55
|
-2.4 Unit on a scale
Standard Error 0.53
|
-2.4 Unit on a scale
Standard Error 0.53
|
|
Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 12
|
-1.4 Unit on a scale
Standard Error 0.49
|
-2.1 Unit on a scale
Standard Error 0.48
|
-1.2 Unit on a scale
Standard Error 0.51
|
-2.2 Unit on a scale
Standard Error 0.48
|
-2.4 Unit on a scale
Standard Error 0.49
|
-0.9 Unit on a scale
Standard Error 0.51
|
-2.5 Unit on a scale
Standard Error 0.62
|
-2.5 Unit on a scale
Standard Error 0.59
|
-2.3 Unit on a scale
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Baseline, Week 14 and 16Population: EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, "number analyzed" signifies the number of participants evaluable at specified time points.
The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=36 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=49 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=38 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in PASI Scores at Week 14 and 16
Baseline
|
6.12 Unit on a scale
Standard Deviation 2.870
|
7.19 Unit on a scale
Standard Deviation 3.370
|
6.46 Unit on a scale
Standard Deviation 2.932
|
6.63 Unit on a scale
Standard Deviation 3.468
|
6.83 Unit on a scale
Standard Deviation 3.137
|
6.08 Unit on a scale
Standard Deviation 2.558
|
7.07 Unit on a scale
Standard Deviation 3.579
|
5.80 Unit on a scale
Standard Deviation 2.765
|
7.94 Unit on a scale
Standard Deviation 4.071
|
|
Change From Baseline in PASI Scores at Week 14 and 16
Change at Week 14
|
-0.83 Unit on a scale
Standard Deviation 2.379
|
-2.24 Unit on a scale
Standard Deviation 2.945
|
-0.72 Unit on a scale
Standard Deviation 4.107
|
-1.81 Unit on a scale
Standard Deviation 3.228
|
-1.87 Unit on a scale
Standard Deviation 2.942
|
-0.82 Unit on a scale
Standard Deviation 3.581
|
-1.04 Unit on a scale
Standard Deviation 3.732
|
-2.06 Unit on a scale
Standard Deviation 3.343
|
-1.19 Unit on a scale
Standard Deviation 3.323
|
|
Change From Baseline in PASI Scores at Week 14 and 16
Change at Week 16
|
-0.46 Unit on a scale
Standard Deviation 2.603
|
-2.06 Unit on a scale
Standard Deviation 3.252
|
-0.78 Unit on a scale
Standard Deviation 4.223
|
-2.10 Unit on a scale
Standard Deviation 3.666
|
-1.68 Unit on a scale
Standard Deviation 3.255
|
-0.67 Unit on a scale
Standard Deviation 4.008
|
-0.71 Unit on a scale
Standard Deviation 3.455
|
-1.75 Unit on a scale
Standard Deviation 3.887
|
-1.03 Unit on a scale
Standard Deviation 3.351
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 10 and 12Population: EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points.
The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=32 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=34 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=45 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=34 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=37 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 1
|
-15.5 Percent change
Standard Error 3.62
|
-12.9 Percent change
Standard Error 3.57
|
-8.2 Percent change
Standard Error 3.56
|
-10.4 Percent change
Standard Error 3.49
|
-13.0 Percent change
Standard Error 3.51
|
-7.4 Percent change
Standard Error 3.10
|
-9.0 Percent change
Standard Error 3.64
|
-13.7 Percent change
Standard Error 3.58
|
-13.5 Percent change
Standard Error 3.52
|
|
Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 2
|
-21.6 Percent change
Standard Error 4.25
|
-12.4 Percent change
Standard Error 4.10
|
-12.6 Percent change
Standard Error 4.34
|
-17.9 Percent change
Standard Error 4.13
|
-19.8 Percent change
Standard Error 4.14
|
-11.7 Percent change
Standard Error 3.99
|
-20.7 Percent change
Standard Error 4.60
|
-23.3 Percent change
Standard Error 4.68
|
-24.7 Percent change
Standard Error 4.58
|
|
Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 4
|
-24.1 Percent change
Standard Error 4.69
|
-20.5 Percent change
Standard Error 4.65
|
-15.6 Percent change
Standard Error 4.90
|
-17.6 Percent change
Standard Error 4.59
|
-25.1 Percent change
Standard Error 4.61
|
-13.2 Percent change
Standard Error 5.69
|
-33.9 Percent change
Standard Error 6.85
|
-24.1 Percent change
Standard Error 6.66
|
-29.2 Percent change
Standard Error 6.64
|
|
Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 6
|
-23.7 Percent change
Standard Error 5.88
|
-20.3 Percent change
Standard Error 5.83
|
-18.4 Percent change
Standard Error 6.18
|
-21.8 Percent change
Standard Error 5.83
|
-36.0 Percent change
Standard Error 5.92
|
-17.8 Percent change
Standard Error 6.10
|
-36.6 Percent change
Standard Error 7.31
|
-31.2 Percent change
Standard Error 7.12
|
-27.5 Percent change
Standard Error 7.08
|
|
Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 8
|
-25.3 Percent change
Standard Error 6.48
|
-25.6 Percent change
Standard Error 6.44
|
-14.3 Percent change
Standard Error 6.78
|
-30.5 Percent change
Standard Error 6.41
|
-35.9 Percent change
Standard Error 6.57
|
-18.1 Percent change
Standard Error 6.70
|
-35.2 Percent change
Standard Error 8.07
|
-32.4 Percent change
Standard Error 7.76
|
-34.3 Percent change
Standard Error 7.76
|
|
Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 10
|
-26.8 Percent change
Standard Error 6.42
|
-27.6 Percent change
Standard Error 6.34
|
-22.9 Percent change
Standard Error 6.73
|
-35.3 Percent change
Standard Error 6.36
|
-36.1 Percent change
Standard Error 6.48
|
-12.5 Percent change
Standard Error 7.62
|
-33.4 Percent change
Standard Error 9.12
|
-35.1 Percent change
Standard Error 8.75
|
-34.6 Percent change
Standard Error 8.77
|
|
Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 12
|
-20.0 Percent change
Standard Error 7.36
|
-29.1 Percent change
Standard Error 7.30
|
-18.5 Percent change
Standard Error 7.70
|
-33.7 Percent change
Standard Error 7.30
|
-39.0 Percent change
Standard Error 7.47
|
-9.6 Percent change
Standard Error 8.61
|
-34.1 Percent change
Standard Error 10.35
|
-35.7 Percent change
Standard Error 9.84
|
-33.7 Percent change
Standard Error 9.88
|
SECONDARY outcome
Timeframe: Baseline, Week 14 and 16Population: EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, "number analyzed" signifies the number of participants evaluable at specified time points.
The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=36 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=49 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=38 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in PASI Scores at Week 14 and 16
Baseline
|
6.12 Percent change
Standard Deviation 2.870
|
7.19 Percent change
Standard Deviation 3.370
|
6.46 Percent change
Standard Deviation 2.932
|
6.63 Percent change
Standard Deviation 3.468
|
6.83 Percent change
Standard Deviation 3.137
|
6.08 Percent change
Standard Deviation 2.558
|
7.07 Percent change
Standard Deviation 3.579
|
5.80 Percent change
Standard Deviation 2.765
|
7.94 Percent change
Standard Deviation 4.071
|
|
Percent Change From Baseline in PASI Scores at Week 14 and 16
Change at Week 14
|
-12.76 Percent change
Standard Deviation 49.660
|
-25.94 Percent change
Standard Deviation 40.339
|
-8.58 Percent change
Standard Deviation 59.407
|
-23.14 Percent change
Standard Deviation 47.501
|
-30.07 Percent change
Standard Deviation 40.222
|
-5.74 Percent change
Standard Deviation 74.846
|
-14.18 Percent change
Standard Deviation 58.599
|
-27.56 Percent change
Standard Deviation 45.370
|
-19.74 Percent change
Standard Deviation 49.727
|
|
Percent Change From Baseline in PASI Scores at Week 14 and 16
Change at Week 16
|
-4.72 Percent change
Standard Deviation 56.401
|
-23.01 Percent change
Standard Deviation 44.766
|
-9.00 Percent change
Standard Deviation 60.088
|
-29.24 Percent change
Standard Deviation 52.608
|
-27.17 Percent change
Standard Deviation 41.153
|
-3.75 Percent change
Standard Deviation 83.415
|
-9.99 Percent change
Standard Deviation 60.306
|
-24.09 Percent change
Standard Deviation 48.685
|
-21.12 Percent change
Standard Deviation 52.521
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 10 and 12Population: EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points.
Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=35 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=34 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=48 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=31 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Baseline
|
4.6 Unit on a scale
Standard Error 0.31
|
4.4 Unit on a scale
Standard Error 0.30
|
4.5 Unit on a scale
Standard Error 0.31
|
4.1 Unit on a scale
Standard Error 0.33
|
4.5 Unit on a scale
Standard Error 0.29
|
4.9 Unit on a scale
Standard Error 0.28
|
4.8 Unit on a scale
Standard Error 0.32
|
4.4 Unit on a scale
Standard Error 0.32
|
5.4 Unit on a scale
Standard Error 0.34
|
|
Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Week 1
|
4.1 Unit on a scale
Standard Error 0.31
|
3.9 Unit on a scale
Standard Error 0.30
|
3.6 Unit on a scale
Standard Error 0.31
|
3.5 Unit on a scale
Standard Error 0.33
|
3.6 Unit on a scale
Standard Error 0.30
|
4.0 Unit on a scale
Standard Error 0.28
|
3.8 Unit on a scale
Standard Error 0.32
|
3.4 Unit on a scale
Standard Error 0.32
|
3.7 Unit on a scale
Standard Error 0.35
|
|
Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Week 2
|
3.6 Unit on a scale
Standard Error 0.31
|
3.5 Unit on a scale
Standard Error 0.31
|
3.3 Unit on a scale
Standard Error 0.31
|
3.2 Unit on a scale
Standard Error 0.33
|
3.5 Unit on a scale
Standard Error 0.30
|
3.5 Unit on a scale
Standard Error 0.28
|
3.6 Unit on a scale
Standard Error 0.32
|
2.9 Unit on a scale
Standard Error 0.32
|
3.4 Unit on a scale
Standard Error 0.35
|
|
Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Week 4
|
3.5 Unit on a scale
Standard Error 0.32
|
3.7 Unit on a scale
Standard Error 0.32
|
3.2 Unit on a scale
Standard Error 0.33
|
3.2 Unit on a scale
Standard Error 0.34
|
3.2 Unit on a scale
Standard Error 0.30
|
3.4 Unit on a scale
Standard Error 0.29
|
3.0 Unit on a scale
Standard Error 0.34
|
3.0 Unit on a scale
Standard Error 0.34
|
3.4 Unit on a scale
Standard Error 0.36
|
|
Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Week 6
|
3.5 Unit on a scale
Standard Error 0.32
|
4.0 Unit on a scale
Standard Error 0.32
|
3.5 Unit on a scale
Standard Error 0.34
|
3.2 Unit on a scale
Standard Error 0.34
|
2.9 Unit on a scale
Standard Error 0.32
|
3.6 Unit on a scale
Standard Error 0.31
|
2.8 Unit on a scale
Standard Error 0.35
|
3.0 Unit on a scale
Standard Error 0.35
|
2.9 Unit on a scale
Standard Error 0.38
|
|
Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Week 8
|
3.1 Unit on a scale
Standard Error 0.32
|
3.4 Unit on a scale
Standard Error 0.32
|
3.2 Unit on a scale
Standard Error 0.33
|
3.1 Unit on a scale
Standard Error 0.34
|
2.8 Unit on a scale
Standard Error 0.32
|
3.3 Unit on a scale
Standard Error 0.32
|
2.7 Unit on a scale
Standard Error 0.37
|
2.9 Unit on a scale
Standard Error 0.35
|
2.7 Unit on a scale
Standard Error 0.38
|
|
Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Week 10
|
3.3 Unit on a scale
Standard Error 0.33
|
3.0 Unit on a scale
Standard Error 0.33
|
3.0 Unit on a scale
Standard Error 0.34
|
3.1 Unit on a scale
Standard Error 0.35
|
2.3 Unit on a scale
Standard Error 0.32
|
4.1 Unit on a scale
Standard Error 0.33
|
2.8 Unit on a scale
Standard Error 0.36
|
2.9 Unit on a scale
Standard Error 0.35
|
3.6 Unit on a scale
Standard Error 0.39
|
|
Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Week 12
|
3.4 Unit on a scale
Standard Error 0.33
|
3.1 Unit on a scale
Standard Error 0.33
|
3.1 Unit on a scale
Standard Error 0.33
|
3.0 Unit on a scale
Standard Error 0.35
|
2.6 Unit on a scale
Standard Error 0.32
|
4.0 Unit on a scale
Standard Error 0.32
|
2.7 Unit on a scale
Standard Error 0.37
|
3.0 Unit on a scale
Standard Error 0.35
|
3.2 Unit on a scale
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Week 14 and 16Population: EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points.
Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=28 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=27 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=24 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=24 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=27 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=30 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=23 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=25 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=23 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute PP-NRS Score at Week 14 and 16
Week 14
|
5.2 Unit on a scale
Standard Deviation 3.02
|
2.6 Unit on a scale
Standard Deviation 2.52
|
2.8 Unit on a scale
Standard Deviation 2.38
|
2.4 Unit on a scale
Standard Deviation 2.39
|
3.2 Unit on a scale
Standard Deviation 2.38
|
4.0 Unit on a scale
Standard Deviation 2.77
|
3.5 Unit on a scale
Standard Deviation 2.89
|
2.8 Unit on a scale
Standard Deviation 2.57
|
5.5 Unit on a scale
Standard Deviation 2.81
|
|
Absolute PP-NRS Score at Week 14 and 16
Week 16
|
4.9 Unit on a scale
Standard Deviation 2.93
|
3.2 Unit on a scale
Standard Deviation 2.75
|
3.1 Unit on a scale
Standard Deviation 2.63
|
2.5 Unit on a scale
Standard Deviation 2.45
|
3.2 Unit on a scale
Standard Deviation 2.42
|
3.8 Unit on a scale
Standard Deviation 2.69
|
3.4 Unit on a scale
Standard Deviation 2.77
|
3.5 Unit on a scale
Standard Deviation 2.91
|
5.8 Unit on a scale
Standard Deviation 2.76
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 10 and 12Population: EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points.
Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=33 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=34 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=32 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=29 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=43 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=33 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=32 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=28 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 1
|
-0.4 Unit on a scale
Standard Error 0.23
|
-0.6 Unit on a scale
Standard Error 0.23
|
-0.9 Unit on a scale
Standard Error 0.23
|
-0.9 Unit on a scale
Standard Error 0.25
|
-0.9 Unit on a scale
Standard Error 0.22
|
-0.9 Unit on a scale
Standard Error 0.24
|
-1.0 Unit on a scale
Standard Error 0.27
|
-1.4 Unit on a scale
Standard Error 0.28
|
-1.2 Unit on a scale
Standard Error 0.30
|
|
Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 2
|
-0.9 Unit on a scale
Standard Error 0.28
|
-0.9 Unit on a scale
Standard Error 0.27
|
-1.1 Unit on a scale
Standard Error 0.28
|
-1.2 Unit on a scale
Standard Error 0.30
|
-1.0 Unit on a scale
Standard Error 0.27
|
-1.3 Unit on a scale
Standard Error 0.25
|
-1.3 Unit on a scale
Standard Error 0.29
|
-1.9 Unit on a scale
Standard Error 0.30
|
-1.5 Unit on a scale
Standard Error 0.32
|
|
Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 4
|
-1.0 Unit on a scale
Standard Error 0.33
|
-0.8 Unit on a scale
Standard Error 0.33
|
-1.0 Unit on a scale
Standard Error 0.34
|
-1.2 Unit on a scale
Standard Error 0.36
|
-1.2 Unit on a scale
Standard Error 0.32
|
-1.3 Unit on a scale
Standard Error 0.32
|
-1.7 Unit on a scale
Standard Error 0.38
|
-1.7 Unit on a scale
Standard Error 0.38
|
-1.6 Unit on a scale
Standard Error 0.41
|
|
Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 6
|
-0.9 Unit on a scale
Standard Error 0.36
|
-0.4 Unit on a scale
Standard Error 0.36
|
-1.0 Unit on a scale
Standard Error 0.38
|
-1.2 Unit on a scale
Standard Error 0.39
|
-1.6 Unit on a scale
Standard Error 0.36
|
-1.1 Unit on a scale
Standard Error 0.31
|
-1.9 Unit on a scale
Standard Error 0.36
|
-1.8 Unit on a scale
Standard Error 0.36
|
-2.1 Unit on a scale
Standard Error 0.39
|
|
Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 8
|
-1.4 Unit on a scale
Standard Error 0.38
|
-1.1 Unit on a scale
Standard Error 0.38
|
-1.2 Unit on a scale
Standard Error 0.39
|
-1.3 Unit on a scale
Standard Error 0.41
|
-1.6 Unit on a scale
Standard Error 0.38
|
-1.2 Unit on a scale
Standard Error 0.38
|
-2.2 Unit on a scale
Standard Error 0.44
|
-1.8 Unit on a scale
Standard Error 0.43
|
-2.2 Unit on a scale
Standard Error 0.46
|
|
Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 10
|
-1.1 Unit on a scale
Standard Error 0.43
|
-1.4 Unit on a scale
Standard Error 0.44
|
-1.3 Unit on a scale
Standard Error 0.45
|
-1.2 Unit on a scale
Standard Error 0.46
|
-2.1 Unit on a scale
Standard Error 0.42
|
-0.5 Unit on a scale
Standard Error 0.39
|
-2.1 Unit on a scale
Standard Error 0.44
|
-1.9 Unit on a scale
Standard Error 0.42
|
-1.2 Unit on a scale
Standard Error 0.47
|
|
Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12
Change at Week 12
|
-1.0 Unit on a scale
Standard Error 0.42
|
-1.3 Unit on a scale
Standard Error 0.43
|
-1.2 Unit on a scale
Standard Error 0.44
|
-1.3 Unit on a scale
Standard Error 0.45
|
-1.8 Unit on a scale
Standard Error 0.42
|
-0.6 Unit on a scale
Standard Error 0.41
|
-2.3 Unit on a scale
Standard Error 0.47
|
-1.8 Unit on a scale
Standard Error 0.44
|
-1.5 Unit on a scale
Standard Error 0.49
|
SECONDARY outcome
Timeframe: Baseline, Week 14 and 16Population: EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points.
Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=26 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=24 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=23 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=20 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=27 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=27 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=21 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=23 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=18 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in PP-NRS Score at Week 14 and 16
Change at Week 14
|
-0.4 Unit on a scale
Standard Deviation 3.18
|
-1.4 Unit on a scale
Standard Deviation 1.64
|
-1.8 Unit on a scale
Standard Deviation 3.16
|
-1.2 Unit on a scale
Standard Deviation 2.52
|
-1.1 Unit on a scale
Standard Deviation 2.38
|
-1.0 Unit on a scale
Standard Deviation 2.93
|
-1.1 Unit on a scale
Standard Deviation 2.57
|
-1.3 Unit on a scale
Standard Deviation 2.31
|
-0.1 Unit on a scale
Standard Deviation 4.18
|
|
Change From Baseline in PP-NRS Score at Week 14 and 16
Change at Week 16
|
-0.6 Unit on a scale
Standard Deviation 2.97
|
-0.9 Unit on a scale
Standard Deviation 1.82
|
-1.2 Unit on a scale
Standard Deviation 3.21
|
-0.7 Unit on a scale
Standard Deviation 2.02
|
-1.0 Unit on a scale
Standard Deviation 2.52
|
-0.9 Unit on a scale
Standard Deviation 2.99
|
-1.0 Unit on a scale
Standard Deviation 2.29
|
-0.9 Unit on a scale
Standard Deviation 2.25
|
0.4 Unit on a scale
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET (Prior to Week 12), ET Follow-up Visit 1 (2 weeks post ET) and 2 (4 weeks post ET)Population: EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points.
PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=35 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=34 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=48 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=31 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2
ET
|
7.7 Unit on a scale
Standard Deviation 4.04
|
13.0 Unit on a scale
Standard Deviation 1.00
|
12.8 Unit on a scale
Standard Deviation 6.76
|
13.3 Unit on a scale
Standard Deviation 7.02
|
15.8 Unit on a scale
Standard Deviation 11.73
|
18.7 Unit on a scale
Standard Deviation 10.23
|
18.0 Unit on a scale
Standard Deviation 11.87
|
11.0 Unit on a scale
Standard Deviation 8.21
|
19.3 Unit on a scale
Standard Deviation 8.14
|
|
Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2
ET follow-up visit 1
|
7.0 Unit on a scale
Standard Deviation 4.24
|
9.0 Unit on a scale
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants with event.
|
6.0 Unit on a scale
Standard Deviation 4.24
|
4.0 Unit on a scale
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants with event.
|
2.0 Unit on a scale
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants with event.
|
19.0 Unit on a scale
Standard Deviation 15.56
|
8.5 Unit on a scale
Standard Deviation 2.12
|
4.0 Unit on a scale
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants with event.
|
7.0 Unit on a scale
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants with event.
|
|
Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2
ET follow-up visit 2
|
8.0 Unit on a scale
Standard Deviation 5.66
|
7.0 Unit on a scale
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants with event.
|
4.5 Unit on a scale
Standard Deviation 2.12
|
4.0 Unit on a scale
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants with event.
|
22.5 Unit on a scale
Standard Deviation 9.19
|
17.8 Unit on a scale
Standard Deviation 11.41
|
4.0 Unit on a scale
Standard Deviation 0.00
|
13.0 Unit on a scale
Standard Deviation 13.74
|
15.5 Unit on a scale
Standard Deviation 10.61
|
|
Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2
Baseline
|
14.2 Unit on a scale
Standard Deviation 5.96
|
12.3 Unit on a scale
Standard Deviation 7.18
|
13.2 Unit on a scale
Standard Deviation 6.55
|
10.3 Unit on a scale
Standard Deviation 5.00
|
12.3 Unit on a scale
Standard Deviation 6.48
|
14.0 Unit on a scale
Standard Deviation 6.60
|
13.0 Unit on a scale
Standard Deviation 6.09
|
10.1 Unit on a scale
Standard Deviation 5.70
|
16.6 Unit on a scale
Standard Deviation 7.01
|
|
Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2
Week 1
|
11.2 Unit on a scale
Standard Deviation 4.17
|
9.1 Unit on a scale
Standard Deviation 5.85
|
9.7 Unit on a scale
Standard Deviation 5.29
|
7.8 Unit on a scale
Standard Deviation 4.23
|
8.9 Unit on a scale
Standard Deviation 6.10
|
9.6 Unit on a scale
Standard Deviation 4.86
|
9.5 Unit on a scale
Standard Deviation 4.86
|
7.0 Unit on a scale
Standard Deviation 4.96
|
9.7 Unit on a scale
Standard Deviation 4.24
|
|
Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2
Week 2
|
10.3 Unit on a scale
Standard Deviation 4.57
|
8.4 Unit on a scale
Standard Deviation 5.07
|
9.2 Unit on a scale
Standard Deviation 5.03
|
7.1 Unit on a scale
Standard Deviation 4.01
|
8.2 Unit on a scale
Standard Deviation 5.17
|
8.4 Unit on a scale
Standard Deviation 4.52
|
9.1 Unit on a scale
Standard Deviation 5.47
|
6.0 Unit on a scale
Standard Deviation 4.30
|
8.4 Unit on a scale
Standard Deviation 3.62
|
|
Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2
Week 4
|
11.6 Unit on a scale
Standard Deviation 5.81
|
9.2 Unit on a scale
Standard Deviation 5.25
|
9.9 Unit on a scale
Standard Deviation 5.29
|
7.3 Unit on a scale
Standard Deviation 3.97
|
8.1 Unit on a scale
Standard Deviation 4.89
|
9.6 Unit on a scale
Standard Deviation 6.96
|
7.9 Unit on a scale
Standard Deviation 5.57
|
6.6 Unit on a scale
Standard Deviation 4.60
|
8.3 Unit on a scale
Standard Deviation 3.99
|
|
Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2
Week 6
|
11.6 Unit on a scale
Standard Deviation 6.61
|
9.7 Unit on a scale
Standard Deviation 5.79
|
10.4 Unit on a scale
Standard Deviation 6.20
|
6.2 Unit on a scale
Standard Deviation 3.79
|
7.6 Unit on a scale
Standard Deviation 4.69
|
8.8 Unit on a scale
Standard Deviation 5.96
|
6.1 Unit on a scale
Standard Deviation 3.23
|
6.9 Unit on a scale
Standard Deviation 5.06
|
8.2 Unit on a scale
Standard Deviation 4.23
|
|
Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2
Week 8
|
11.3 Unit on a scale
Standard Deviation 5.82
|
8.7 Unit on a scale
Standard Deviation 5.87
|
9.7 Unit on a scale
Standard Deviation 6.62
|
6.1 Unit on a scale
Standard Deviation 3.73
|
7.0 Unit on a scale
Standard Deviation 4.61
|
8.4 Unit on a scale
Standard Deviation 5.46
|
7.2 Unit on a scale
Standard Deviation 4.75
|
7.5 Unit on a scale
Standard Deviation 4.92
|
8.0 Unit on a scale
Standard Deviation 4.68
|
|
Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2
Week 10
|
11.7 Unit on a scale
Standard Deviation 7.09
|
8.0 Unit on a scale
Standard Deviation 6.29
|
9.5 Unit on a scale
Standard Deviation 5.89
|
6.5 Unit on a scale
Standard Deviation 3.66
|
6.4 Unit on a scale
Standard Deviation 4.87
|
7.8 Unit on a scale
Standard Deviation 4.92
|
6.7 Unit on a scale
Standard Deviation 3.13
|
6.7 Unit on a scale
Standard Deviation 4.60
|
9.5 Unit on a scale
Standard Deviation 4.97
|
|
Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2
Week 12
|
11.7 Unit on a scale
Standard Deviation 7.40
|
7.8 Unit on a scale
Standard Deviation 6.41
|
9.7 Unit on a scale
Standard Deviation 6.45
|
5.9 Unit on a scale
Standard Deviation 3.38
|
6.2 Unit on a scale
Standard Deviation 4.69
|
8.0 Unit on a scale
Standard Deviation 5.13
|
6.1 Unit on a scale
Standard Deviation 3.67
|
6.8 Unit on a scale
Standard Deviation 5.14
|
8.3 Unit on a scale
Standard Deviation 4.79
|
|
Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2
Week 14
|
14.3 Unit on a scale
Standard Deviation 8.09
|
8.1 Unit on a scale
Standard Deviation 6.37
|
8.9 Unit on a scale
Standard Deviation 6.09
|
6.8 Unit on a scale
Standard Deviation 5.00
|
9.2 Unit on a scale
Standard Deviation 6.12
|
10.4 Unit on a scale
Standard Deviation 5.98
|
11.2 Unit on a scale
Standard Deviation 7.54
|
8.5 Unit on a scale
Standard Deviation 6.04
|
11.5 Unit on a scale
Standard Deviation 5.26
|
|
Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2
Week 16
|
14.0 Unit on a scale
Standard Deviation 7.60
|
8.6 Unit on a scale
Standard Deviation 6.30
|
9.8 Unit on a scale
Standard Deviation 5.47
|
7.4 Unit on a scale
Standard Deviation 5.03
|
8.9 Unit on a scale
Standard Deviation 6.77
|
10.4 Unit on a scale
Standard Deviation 6.18
|
11.5 Unit on a scale
Standard Deviation 7.20
|
10.2 Unit on a scale
Standard Deviation 6.82
|
11.9 Unit on a scale
Standard Deviation 7.33
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET (Prior to Week 12), ET Follow-up Visit 1 (2 weeks post ET) and 2 (4 weeks post ET)Population: EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points.
PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=33 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=34 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=32 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=29 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=43 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=33 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=33 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=28 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2
Change at ET Follow-up Visit 2
|
-1.5 Unit on a scale
Standard Deviation 2.12
|
-11.0 Unit on a scale
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants with event.
|
-6.5 Unit on a scale
Standard Deviation 4.95
|
-4.0 Unit on a scale
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants with event.
|
6.5 Unit on a scale
Standard Deviation 9.19
|
0.8 Unit on a scale
Standard Deviation 7.14
|
-11.0 Unit on a scale
Standard Deviation 4.24
|
-0.3 Unit on a scale
Standard Deviation 8.26
|
-1.0 Unit on a scale
Standard Deviation 9.90
|
|
Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2
Change at Week 1
|
-3.3 Unit on a scale
Standard Deviation 4.94
|
-2.8 Unit on a scale
Standard Deviation 3.35
|
-3.0 Unit on a scale
Standard Deviation 3.84
|
-2.6 Unit on a scale
Standard Deviation 2.95
|
-3.4 Unit on a scale
Standard Deviation 4.17
|
-3.9 Unit on a scale
Standard Deviation 5.00
|
-3.7 Unit on a scale
Standard Deviation 3.49
|
-3.4 Unit on a scale
Standard Deviation 3.18
|
-6.6 Unit on a scale
Standard Deviation 4.80
|
|
Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2
Change at Week 2
|
-4.0 Unit on a scale
Standard Deviation 5.46
|
-3.9 Unit on a scale
Standard Deviation 4.91
|
-4.1 Unit on a scale
Standard Deviation 4.36
|
-3.1 Unit on a scale
Standard Deviation 3.63
|
-3.8 Unit on a scale
Standard Deviation 4.62
|
-5.1 Unit on a scale
Standard Deviation 5.85
|
-4.2 Unit on a scale
Standard Deviation 3.91
|
-4.3 Unit on a scale
Standard Deviation 4.12
|
-7.8 Unit on a scale
Standard Deviation 5.37
|
|
Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2
Change at Week 4
|
-3.0 Unit on a scale
Standard Deviation 6.33
|
-3.4 Unit on a scale
Standard Deviation 5.09
|
-3.5 Unit on a scale
Standard Deviation 5.12
|
-2.6 Unit on a scale
Standard Deviation 3.91
|
-4.1 Unit on a scale
Standard Deviation 4.55
|
-3.9 Unit on a scale
Standard Deviation 6.50
|
-4.6 Unit on a scale
Standard Deviation 5.44
|
-3.7 Unit on a scale
Standard Deviation 4.57
|
-6.5 Unit on a scale
Standard Deviation 5.44
|
|
Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2
Change at Week 6
|
-3.5 Unit on a scale
Standard Deviation 7.09
|
-3.1 Unit on a scale
Standard Deviation 5.30
|
-2.0 Unit on a scale
Standard Deviation 6.20
|
-3.5 Unit on a scale
Standard Deviation 5.22
|
-4.0 Unit on a scale
Standard Deviation 4.64
|
-5.1 Unit on a scale
Standard Deviation 7.40
|
-6.3 Unit on a scale
Standard Deviation 5.05
|
-3.4 Unit on a scale
Standard Deviation 4.60
|
-6.5 Unit on a scale
Standard Deviation 5.75
|
|
Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2
Change at Week 8
|
-4.1 Unit on a scale
Standard Deviation 7.20
|
-3.5 Unit on a scale
Standard Deviation 4.60
|
-3.2 Unit on a scale
Standard Deviation 6.56
|
-3.7 Unit on a scale
Standard Deviation 5.01
|
-4.1 Unit on a scale
Standard Deviation 5.01
|
-5.2 Unit on a scale
Standard Deviation 8.12
|
-5.8 Unit on a scale
Standard Deviation 5.35
|
-3.2 Unit on a scale
Standard Deviation 4.90
|
-7.0 Unit on a scale
Standard Deviation 6.64
|
|
Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2
Change at Week 10
|
-4.0 Unit on a scale
Standard Deviation 7.57
|
-4.0 Unit on a scale
Standard Deviation 4.90
|
-3.4 Unit on a scale
Standard Deviation 6.24
|
-3.3 Unit on a scale
Standard Deviation 6.12
|
-5.3 Unit on a scale
Standard Deviation 5.69
|
-5.5 Unit on a scale
Standard Deviation 8.08
|
-5.1 Unit on a scale
Standard Deviation 5.12
|
-3.9 Unit on a scale
Standard Deviation 4.82
|
-5.8 Unit on a scale
Standard Deviation 7.62
|
|
Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2
Change at Week 12
|
-3.8 Unit on a scale
Standard Deviation 7.74
|
-4.1 Unit on a scale
Standard Deviation 4.98
|
-3.2 Unit on a scale
Standard Deviation 5.63
|
-3.7 Unit on a scale
Standard Deviation 6.13
|
-5.2 Unit on a scale
Standard Deviation 6.04
|
-5.0 Unit on a scale
Standard Deviation 8.15
|
-5.2 Unit on a scale
Standard Deviation 4.82
|
-3.7 Unit on a scale
Standard Deviation 5.67
|
-6.6 Unit on a scale
Standard Deviation 7.82
|
|
Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2
Change at Week 14
|
-0.7 Unit on a scale
Standard Deviation 7.86
|
-2.9 Unit on a scale
Standard Deviation 4.68
|
-4.4 Unit on a scale
Standard Deviation 7.49
|
-3.1 Unit on a scale
Standard Deviation 6.87
|
-2.2 Unit on a scale
Standard Deviation 5.49
|
-3.5 Unit on a scale
Standard Deviation 7.87
|
-1.4 Unit on a scale
Standard Deviation 5.53
|
-2.3 Unit on a scale
Standard Deviation 4.98
|
-2.9 Unit on a scale
Standard Deviation 7.98
|
|
Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2
Change at Week 16
|
-0.9 Unit on a scale
Standard Deviation 7.61
|
-2.4 Unit on a scale
Standard Deviation 5.02
|
-3.2 Unit on a scale
Standard Deviation 6.37
|
-2.4 Unit on a scale
Standard Deviation 7.27
|
-2.1 Unit on a scale
Standard Deviation 6.05
|
-2.6 Unit on a scale
Standard Deviation 7.12
|
-0.8 Unit on a scale
Standard Deviation 4.29
|
-0.8 Unit on a scale
Standard Deviation 5.28
|
-2.7 Unit on a scale
Standard Deviation 8.40
|
|
Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2
Change at ET
|
-2.7 Unit on a scale
Standard Deviation 2.52
|
0.7 Unit on a scale
Standard Deviation 6.11
|
-1.0 Unit on a scale
Standard Deviation 8.29
|
0.3 Unit on a scale
Standard Deviation 2.08
|
-1.3 Unit on a scale
Standard Deviation 6.85
|
0.7 Unit on a scale
Standard Deviation 5.16
|
1.8 Unit on a scale
Standard Deviation 7.40
|
-4.0 Unit on a scale
Standard Deviation 3.00
|
-5.0 Unit on a scale
Standard Deviation 1.41
|
|
Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2
Change at ET Follow-up Visit 1
|
-2.5 Unit on a scale
Standard Deviation 0.71
|
-9.0 Unit on a scale
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants with event.
|
-5.0 Unit on a scale
Standard Deviation 7.07
|
-4.0 Unit on a scale
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants with event.
|
-3.0 Unit on a scale
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants with event.
|
2.0 Unit on a scale
Standard Deviation 9.90
|
-2.5 Unit on a scale
Standard Deviation 0.71
|
-7.0 Unit on a scale
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants with event.
|
-9.0 Unit on a scale
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants with event.
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 10, 14, and 16Population: EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, "number analyzed" signifies the number of participants evaluable at specified time points.
PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category. Scale for PGA: 0= clear, 1= almost clear, 2= mild, 3= moderate and 4= severe. Higher scores indicate more severity.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=36 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=49 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=38 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With PGA Score Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16
Week 1
|
2.8 Percentage of participants
Interval 0.3 to 11.6
|
2.7 Percentage of participants
Interval 0.3 to 11.2
|
2.7 Percentage of participants
Interval 0.3 to 11.2
|
0 Percentage of participants
Interval 0.0 to 7.5
|
0 Percentage of participants
Interval 0.0 to 7.3
|
0 Percentage of participants
Interval 0.0 to 5.5
|
0 Percentage of participants
Interval 0.0 to 7.5
|
5.7 Percentage of participants
Interval 1.5 to 16.4
|
5.3 Percentage of participants
Interval 1.4 to 15.0
|
|
Percentage of Participants With PGA Score Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16
Week 2
|
2.8 Percentage of participants
Interval 0.3 to 11.6
|
0 Percentage of participants
Interval 0.0 to 7.3
|
0 Percentage of participants
Interval 0.0 to 7.3
|
2.8 Percentage of participants
Interval 0.3 to 11.6
|
2.7 Percentage of participants
Interval 0.3 to 11.2
|
2.0 Percentage of participants
Interval 0.2 to 8.4
|
0 Percentage of participants
Interval 0.0 to 7.5
|
5.7 Percentage of participants
Interval 1.5 to 16.4
|
10.5 Percentage of participants
Interval 4.7 to 21.6
|
|
Percentage of Participants With PGA Score Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16
Week 4
|
5.6 Percentage of participants
Interval 1.5 to 15.9
|
5.4 Percentage of participants
Interval 1.4 to 15.5
|
0 Percentage of participants
Interval 0.0 to 7.3
|
5.6 Percentage of participants
Interval 1.5 to 15.9
|
5.4 Percentage of participants
Interval 1.4 to 15.5
|
8.2 Percentage of participants
Interval 3.6 to 16.5
|
8.3 Percentage of participants
Interval 3.1 to 18.9
|
11.4 Percentage of participants
Interval 5.1 to 23.6
|
21.1 Percentage of participants
Interval 10.9 to 33.3
|
|
Percentage of Participants With PGA Score Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16
Week 6
|
8.3 Percentage of participants
Interval 3.1 to 18.9
|
5.4 Percentage of participants
Interval 1.4 to 15.5
|
2.7 Percentage of participants
Interval 0.3 to 11.2
|
8.3 Percentage of participants
Interval 3.1 to 18.9
|
13.5 Percentage of participants
Interval 6.7 to 24.8
|
8.2 Percentage of participants
Interval 3.6 to 16.5
|
8.3 Percentage of participants
Interval 3.1 to 18.9
|
5.7 Percentage of participants
Interval 1.5 to 16.4
|
13.2 Percentage of participants
Interval 6.5 to 24.3
|
|
Percentage of Participants With PGA Score Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16
Week 8
|
11.1 Percentage of participants
Interval 4.9 to 22.9
|
5.4 Percentage of participants
Interval 1.4 to 15.5
|
5.4 Percentage of participants
Interval 1.4 to 15.5
|
2.8 Percentage of participants
Interval 0.3 to 11.6
|
10.8 Percentage of participants
Interval 4.8 to 22.2
|
6.1 Percentage of participants
Interval 2.3 to 14.8
|
13.9 Percentage of participants
Interval 6.9 to 25.4
|
5.7 Percentage of participants
Interval 1.5 to 16.4
|
18.4 Percentage of participants
Interval 10.1 to 30.9
|
|
Percentage of Participants With PGA Score Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16
Week 10
|
8.3 Percentage of participants
Interval 3.1 to 18.9
|
5.4 Percentage of participants
Interval 1.4 to 15.5
|
8.1 Percentage of participants
Interval 3.0 to 18.5
|
8.3 Percentage of participants
Interval 3.1 to 18.9
|
16.2 Percentage of participants
Interval 7.3 to 29.3
|
16.3 Percentage of participants
Interval 8.4 to 27.1
|
16.7 Percentage of participants
Interval 7.5 to 30.2
|
8.6 Percentage of participants
Interval 3.2 to 19.3
|
13.2 Percentage of participants
Interval 6.5 to 24.3
|
|
Percentage of Participants With PGA Score Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16
Week 14
|
2.8 Percentage of participants
Interval 0.3 to 11.6
|
13.5 Percentage of participants
Interval 6.7 to 24.8
|
5.6 Percentage of participants
Interval 1.5 to 15.9
|
8.6 Percentage of participants
Interval 3.2 to 19.3
|
13.5 Percentage of participants
Interval 6.7 to 24.8
|
6.3 Percentage of participants
Interval 2.3 to 15.1
|
8.8 Percentage of participants
Interval 3.3 to 19.7
|
11.8 Percentage of participants
Interval 5.2 to 24.3
|
8.1 Percentage of participants
Interval 3.0 to 18.5
|
|
Percentage of Participants With PGA Score Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16
Week 16
|
5.6 Percentage of participants
Interval 1.5 to 15.9
|
11.4 Percentage of participants
Interval 5.1 to 23.6
|
8.6 Percentage of participants
Interval 3.2 to 19.3
|
14.3 Percentage of participants
Interval 7.1 to 26.0
|
16.2 Percentage of participants
Interval 7.3 to 29.3
|
8.2 Percentage of participants
Interval 3.6 to 16.5
|
14.7 Percentage of participants
Interval 7.3 to 26.9
|
11.8 Percentage of participants
Interval 5.2 to 24.3
|
16.2 Percentage of participants
Interval 7.3 to 29.3
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 6, 8, 10, 12, 14, and 16Population: EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points.
PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=35 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=34 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=48 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=31 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 10
|
31.0 Percentage of participants
Interval 18.9 to 46.3
|
42.9 Percentage of participants
Interval 28.4 to 60.0
|
40.0 Percentage of participants
Interval 24.6 to 58.3
|
62.1 Percentage of participants
Interval 46.3 to 77.1
|
64.3 Percentage of participants
Interval 47.3 to 79.2
|
45.2 Percentage of participants
Interval 29.7 to 60.1
|
50.0 Percentage of participants
Interval 31.9 to 68.1
|
46.4 Percentage of participants
Interval 31.0 to 63.4
|
33.3 Percentage of participants
Interval 17.8 to 52.1
|
|
Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 1
|
5.7 Percentage of participants
Interval 1.5 to 16.4
|
19.4 Percentage of participants
Interval 10.7 to 32.8
|
11.8 Percentage of participants
Interval 5.2 to 24.3
|
22.2 Percentage of participants
Interval 11.6 to 35.3
|
13.5 Percentage of participants
Interval 6.7 to 24.8
|
19.1 Percentage of participants
Interval 11.2 to 30.3
|
11.4 Percentage of participants
Interval 5.1 to 23.6
|
26.5 Percentage of participants
Interval 15.9 to 40.5
|
24.1 Percentage of participants
Interval 13.4 to 38.5
|
|
Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 2
|
8.6 Percentage of participants
Interval 3.2 to 19.3
|
22.2 Percentage of participants
Interval 11.6 to 35.3
|
18.2 Percentage of participants
Interval 8.2 to 31.3
|
34.3 Percentage of participants
Interval 22.0 to 47.8
|
31.4 Percentage of participants
Interval 19.3 to 44.8
|
20.8 Percentage of participants
Interval 11.8 to 31.5
|
25.7 Percentage of participants
Interval 15.4 to 39.2
|
31.4 Percentage of participants
Interval 19.3 to 44.8
|
32.3 Percentage of participants
Interval 18.7 to 48.2
|
|
Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 4
|
15.6 Percentage of participants
Interval 7.8 to 28.7
|
29.0 Percentage of participants
Interval 17.6 to 45.0
|
29.6 Percentage of participants
Interval 15.7 to 45.3
|
48.5 Percentage of participants
Interval 34.4 to 63.9
|
38.2 Percentage of participants
Interval 24.3 to 53.8
|
26.1 Percentage of participants
Interval 15.8 to 37.7
|
31.0 Percentage of participants
Interval 18.9 to 46.3
|
51.6 Percentage of participants
Interval 36.8 to 67.3
|
35.5 Percentage of participants
Interval 21.3 to 51.8
|
|
Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 6
|
18.8 Percentage of participants
Interval 8.5 to 32.0
|
26.7 Percentage of participants
Interval 14.0 to 41.6
|
32.0 Percentage of participants
Interval 17.0 to 50.0
|
54.8 Percentage of participants
Interval 39.9 to 70.3
|
42.9 Percentage of participants
Interval 28.4 to 60.0
|
31.6 Percentage of participants
Interval 19.9 to 45.9
|
66.7 Percentage of participants
Interval 50.0 to 79.6
|
48.1 Percentage of participants
Interval 32.6 to 65.3
|
33.3 Percentage of participants
Interval 20.4 to 50.0
|
|
Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 8
|
23.3 Percentage of participants
Interval 12.9 to 37.6
|
35.5 Percentage of participants
Interval 21.3 to 51.8
|
46.2 Percentage of participants
Interval 29.9 to 63.8
|
67.7 Percentage of participants
Interval 51.8 to 81.3
|
50.0 Percentage of participants
Interval 34.2 to 65.8
|
41.7 Percentage of participants
Interval 29.0 to 56.0
|
62.5 Percentage of participants
Interval 44.7 to 77.9
|
35.7 Percentage of participants
Interval 20.8 to 52.7
|
59.3 Percentage of participants
Interval 41.7 to 75.2
|
|
Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 12
|
24.1 Percentage of participants
Interval 13.4 to 38.5
|
51.7 Percentage of participants
Interval 35.2 to 68.0
|
50.0 Percentage of participants
Interval 34.2 to 65.8
|
62.1 Percentage of participants
Interval 46.3 to 77.1
|
55.6 Percentage of participants
Interval 38.2 to 70.9
|
35.5 Percentage of participants
Interval 21.3 to 51.8
|
56.5 Percentage of participants
Interval 38.1 to 72.7
|
46.4 Percentage of participants
Interval 31.0 to 63.4
|
36.0 Percentage of participants
Interval 21.4 to 54.4
|
|
Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 14
|
7.1 Percentage of participants
Interval 1.9 to 20.1
|
44.0 Percentage of participants
Interval 27.0 to 61.1
|
45.8 Percentage of participants
Interval 28.2 to 63.0
|
54.2 Percentage of participants
Interval 37.0 to 71.8
|
37.0 Percentage of participants
Interval 22.1 to 54.7
|
25.9 Percentage of participants
Interval 14.5 to 41.7
|
30.4 Percentage of participants
Interval 17.3 to 47.9
|
36.0 Percentage of participants
Interval 21.4 to 54.4
|
17.4 Percentage of participants
Interval 7.8 to 33.5
|
|
Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Week 16
|
7.4 Percentage of participants
Interval 2.0 to 20.4
|
44.4 Percentage of participants
Interval 29.1 to 61.8
|
30.4 Percentage of participants
Interval 17.3 to 47.9
|
54.2 Percentage of participants
Interval 37.0 to 71.8
|
52.0 Percentage of participants
Interval 36.0 to 69.3
|
36.7 Percentage of participants
Interval 22.1 to 52.4
|
18.2 Percentage of participants
Interval 8.2 to 35.3
|
22.7 Percentage of participants
Interval 11.5 to 39.5
|
31.6 Percentage of participants
Interval 15.1 to 53.0
|
SECONDARY outcome
Timeframe: Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)Population: Safety analysis set (SAS) included participants who received at least 1 dose of investigational product.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs. Treatment emergent AEs (TEAEs) were events that occurred between first dose of study drug and up to 4 weeks after last dose that were absent before treatment or that worsened relative to pretreatment state. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=37 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=49 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=38 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs
Treatment-emergent AEs
|
17 Participants
|
16 Participants
|
14 Participants
|
17 Participants
|
14 Participants
|
20 Participants
|
13 Participants
|
18 Participants
|
12 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs
Treatment-emergent SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs
Treatment-related AEs
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs
Treatment-related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)Population: SAS included participants who received at least 1 dose of investigational product.
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event).
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=37 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=49 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=38 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs by Severity
Mild
|
12 Participants
|
9 Participants
|
11 Participants
|
11 Participants
|
7 Participants
|
8 Participants
|
7 Participants
|
11 Participants
|
6 Participants
|
|
Number of Participants With TEAEs by Severity
Moderate
|
5 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
11 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With TEAEs by Severity
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)Population: SAS included participants who received at least 1 dose of investigational product.
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=37 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=49 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=38 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued From Study Due to Adverse Events
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)Population: SAS included participants who received at least 1 dose of investigational product. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
Bilirubin: greater than (\>) 1.5\* upper limit normal (ULN); aspartate aminotransferase, alanine aminotransferase: \>2.5\*ULN; creatinine, cystatin C: \>1.3\*ULN; creatine kinase: \>2.0\*ULN; glomerular filtration rate (GFR) CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) Equat: less than (\<) 60 milliliter (mL)/minute (min)/1.73 meter(m)\^2, greater than or equal to (\>=) 30% decrease from baseline; GFR: \<60 mL/min/1.73m\^2.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=37 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=49 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=35 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=38 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities Meeting Specified Criteria
|
7 Participants
|
6 Participants
|
11 Participants
|
7 Participants
|
5 Participants
|
12 Participants
|
5 Participants
|
6 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Post-baseline to Week 6, Post-baseline to Week 12Population: SAS included participants who receive at least 1 dose of investigational product
Following were ECG criteria used for categorical summary:1) PR interval: percentage change \>=25/50%, QRS interval: value \>140 msec, and QT interval corrected using the Fridericia's formula (QTcF): 450 msec \< value less than equal to (\<=) 480 and 30 \< change \<=60.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=37 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=49 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=38 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data
Post-baseline to Week 6: PR interval (>=25/50 percent)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data
Post-baseline to Week 6: QRS interval (>=140 msec)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data
Post-baseline to Week 6: QTcF interval (30< Change <=60)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data
Post-baseline to Week 12: PR interval (>=25/50 percent)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data
Post-baseline to Week 12: QRS interval (>=140 msec)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data
Post-baseline to Week 12: QTcF interval (450< Value <=480)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data
Post-baseline to Week 12: QTcF interval (30 < Chg <= 60)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Post-baseline to Week 12Population: SAS included participants who receive at least 1 dose of investigational product. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points.
Following were the vital signs criteria: 1) Pulse rate: value \<40 beats per min (bpm), value \>120 bpm; 2) Sitting diastolic blood pressure (DBP): value \<50 mmHg; change \>=20 mmHg increase; change \>=20 mmHg decrease; 3) Sitting systolic blood pressure (SBP): value \<90 mmHg, change \>=30 mmHg increase, change \>=30 mmHg decrease; 4) Supine DBP: value \<50 mmHg, change \>=20 mmHg increase, change \>=20 mmHg decrease; 5) Supine SBP: value \<90 mmHg, change \>=30 mmHg increase, change \>=30 mmHg decrease.
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=35 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=34 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=33 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=33 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=34 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=47 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=32 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=34 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Pulse rate < 40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Pulse rate >120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Sitting DBP (<50 mmHg)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Sitting DBP (>=20 mmHg increase)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Sitting DBP (>=20 mmHg decrease)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Sitting SBP (<90 mmHg)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Sitting SBP (>= 30 mmHg increase)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Sitting SBP (>=30 mmHg decrease)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Supine DBP (<50 mmHg)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Supine DBP (>= 20mmHg increase)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Supine DBP (>=20 mmHg decrease)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Supine SBP (<90 mmHg)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Supine SBP (>=30 mmHg increase)
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Supine SBP (>= 30 mmHg decrease)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16Population: SAS included participants who receive at least 1 dose of investigational product. Here, "number analyzed" signifies the number of participants evaluable at specified time points.
At the site of study drug application, skin tolerability was assessed for non-lesional skin surrounding the plaques on a scale from 0 to 4. Grade 0= none (no evidence of local intolerance), Grade 1= mild (minimal erythema and/or edema, slight glazed appearance), Grade 2= moderate (definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology), Grade 3= severe, reported as AE (erythema, oedema glazing with fissures, few vesicles or papules: consider removing topical agent \[if still in place\]), Grade 4= very severe, reported as AE (strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent \[if still in place\]).
Outcome measures
| Measure |
Vehicle Once Daily (QD)
n=37 Participants
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=37 Participants
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=49 Participants
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=36 Participants
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=38 Participants
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 16 · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 16 · Very severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 16 · Missing
|
4 Participants
|
7 Participants
|
9 Participants
|
7 Participants
|
4 Participants
|
10 Participants
|
8 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 1 · Mild
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 1 · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 1 · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 2 · Very severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 1 · Very severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 1 · Missing
|
3 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 2 · None
|
33 Participants
|
35 Participants
|
30 Participants
|
34 Participants
|
35 Participants
|
45 Participants
|
34 Participants
|
35 Participants
|
33 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 2 · Mild
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 2 · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 2 · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 2 · Missing
|
1 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 4 · None
|
34 Participants
|
32 Participants
|
29 Participants
|
32 Participants
|
34 Participants
|
44 Participants
|
30 Participants
|
32 Participants
|
30 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 4 · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 4 · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 4 · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 4 · Very severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 4 · Missing
|
0 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 6 · None
|
32 Participants
|
31 Participants
|
26 Participants
|
30 Participants
|
27 Participants
|
37 Participants
|
28 Participants
|
31 Participants
|
30 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 6 · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 6 · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 6 · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 6 · Very severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 6 · Missing
|
1 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 8 · None
|
29 Participants
|
30 Participants
|
27 Participants
|
30 Participants
|
26 Participants
|
34 Participants
|
26 Participants
|
30 Participants
|
28 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 8 · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 8 · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Day1 · None
|
36 Participants
|
37 Participants
|
36 Participants
|
36 Participants
|
36 Participants
|
48 Participants
|
35 Participants
|
36 Participants
|
37 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Day1 · Mild
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Day1 · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Day1 · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Day1 · Very severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Day1 · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 1 · None
|
32 Participants
|
35 Participants
|
32 Participants
|
34 Participants
|
35 Participants
|
44 Participants
|
32 Participants
|
32 Participants
|
35 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 8 · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 8 · Very severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 8 · Missing
|
2 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 10 · None
|
29 Participants
|
30 Participants
|
24 Participants
|
29 Participants
|
27 Participants
|
34 Participants
|
24 Participants
|
27 Participants
|
26 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 10 · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 10 · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 10 · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 10 · Very severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 10 · Missing
|
3 Participants
|
1 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 12 · None
|
33 Participants
|
32 Participants
|
30 Participants
|
31 Participants
|
30 Participants
|
43 Participants
|
30 Participants
|
32 Participants
|
29 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 12 · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 12 · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 12 · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 12 · Very severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 12 · Missing
|
3 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 14 · None
|
31 Participants
|
27 Participants
|
24 Participants
|
29 Participants
|
30 Participants
|
34 Participants
|
26 Participants
|
26 Participants
|
28 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 14 · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 14 · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 14 · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 14 · Very severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 14 · Missing
|
5 Participants
|
7 Participants
|
10 Participants
|
5 Participants
|
4 Participants
|
11 Participants
|
8 Participants
|
9 Participants
|
5 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 16 · None
|
31 Participants
|
28 Participants
|
26 Participants
|
28 Participants
|
28 Participants
|
35 Participants
|
26 Participants
|
28 Participants
|
26 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 16 · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Week 16 · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Vehicle Once Daily (QD)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-06700841 0.1% QD
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-06700841 0.3% QD
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-06700841 1.0% QD
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
PF-06700841 3.0% QD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Pooled Vehicle BID
Serious events: 1 serious events
Other events: 10 other events
Deaths: 1 deaths
PF-06700841 0.3% BID
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-06700841 1.0% BID
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
PF-06700841 3.0% BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vehicle Once Daily (QD)
n=37 participants at risk
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=37 participants at risk
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=37 participants at risk
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=36 participants at risk
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=37 participants at risk
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=49 participants at risk
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=36 participants at risk
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=36 participants at risk
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=38 participants at risk
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.0%
1/49 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/38 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Bacteraemia
|
2.7%
1/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/49 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/38 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Thrombophlebitis septic
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/49 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.8%
1/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/38 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/49 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.8%
1/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/38 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
|
Investigations
Aspiration bursa
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.8%
1/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/49 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/38 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/49 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.8%
1/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/38 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Depression
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/49 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.8%
1/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/38 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/49 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.8%
1/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/38 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
Other adverse events
| Measure |
Vehicle Once Daily (QD)
n=37 participants at risk
During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.1% QD
n=37 participants at risk
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% QD
n=37 participants at risk
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% QD
n=36 participants at risk
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% QD
n=37 participants at risk
During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
Pooled Vehicle BID
n=49 participants at risk
During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 0.3% BID
n=36 participants at risk
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 1.0% BID
n=36 participants at risk
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 3.0% BID
n=38 participants at risk
During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.8%
4/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
8.1%
3/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.7%
1/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
16.7%
6/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
8.1%
3/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
6.1%
3/49 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.8%
1/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
19.4%
7/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/38 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.7%
1/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
5.4%
2/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.0%
1/49 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/38 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
1/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
5.4%
2/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.7%
1/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
5.4%
2/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
4.1%
2/49 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.8%
1/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.6%
1/38 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.7%
1/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
5.6%
2/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.7%
1/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/49 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/38 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Headache
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
5.4%
2/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/49 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.8%
1/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/38 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
1/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
5.4%
2/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.8%
1/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
4.1%
2/49 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
5.6%
2/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
5.6%
2/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/38 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.7%
1/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.7%
1/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.0%
1/49 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
5.6%
2/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.6%
1/38 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Hypertension
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.7%
1/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
5.4%
2/37 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
4.1%
2/49 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
0.00%
0/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
5.6%
2/36 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
2.6%
1/38 • Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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 the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER