Trial Outcomes & Findings for A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. (NCT NCT05375955)
NCT ID: NCT05375955
Last Updated: 2024-10-02
Results Overview
IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting.95 percentage (%)confidence interval was based on Blyth-Still-Casella method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
263 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2024-10-02
Participant Flow
A total of 263 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
Atopic Dermatitis: Vehicle Ointment
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 Vehicle Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Treatment (12 Weeks)
STARTED
|
44
|
42
|
42
|
34
|
33
|
35
|
33
|
|
Treatment (12 Weeks)
Treated
|
44
|
42
|
42
|
34
|
33
|
35
|
33
|
|
Treatment (12 Weeks)
COMPLETED
|
32
|
34
|
29
|
25
|
28
|
30
|
29
|
|
Treatment (12 Weeks)
NOT COMPLETED
|
12
|
8
|
13
|
9
|
5
|
5
|
4
|
|
Follow-up (up to 5 Weeks)
STARTED
|
36
|
36
|
36
|
25
|
28
|
31
|
31
|
|
Follow-up (up to 5 Weeks)
COMPLETED
|
32
|
35
|
31
|
25
|
27
|
29
|
29
|
|
Follow-up (up to 5 Weeks)
NOT COMPLETED
|
4
|
1
|
5
|
0
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
Atopic Dermatitis: Vehicle Ointment
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 Vehicle Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Treatment (12 Weeks)
Lost to Follow-up
|
0
|
2
|
2
|
1
|
1
|
1
|
0
|
|
Treatment (12 Weeks)
Physician Decision
|
4
|
1
|
3
|
0
|
0
|
1
|
0
|
|
Treatment (12 Weeks)
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment (12 Weeks)
Withdrawal by parent/guardian
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment (12 Weeks)
Withdrawal by Subject
|
8
|
4
|
7
|
8
|
4
|
3
|
3
|
|
Treatment (12 Weeks)
Pregnancy
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Follow-up (up to 5 Weeks)
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Follow-up (up to 5 Weeks)
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Follow-up (up to 5 Weeks)
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up (up to 5 Weeks)
Physician's decision
|
2
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Follow-up (up to 5 Weeks)
Lost to Follow-up
|
1
|
0
|
1
|
0
|
1
|
1
|
2
|
Baseline Characteristics
A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
Baseline characteristics by cohort
| Measure |
Atopic Dermatitis: Vehicle Ointment
n=44 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 Vehicle Ointment
n=34 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
n=35 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.8 Years
STANDARD_DEVIATION 18.55 • n=5 Participants
|
44.1 Years
STANDARD_DEVIATION 15.31 • n=7 Participants
|
40.0 Years
STANDARD_DEVIATION 16.28 • n=5 Participants
|
52.6 Years
STANDARD_DEVIATION 12.28 • n=4 Participants
|
47.8 Years
STANDARD_DEVIATION 13.37 • n=21 Participants
|
55.7 Years
STANDARD_DEVIATION 15.11 • n=8 Participants
|
50.0 Years
STANDARD_DEVIATION 17.33 • n=8 Participants
|
51.6 Years
STANDARD_DEVIATION 14.77 • n=24 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
127 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
136 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
66 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
187 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
60 Participants
n=24 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
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
39 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
157 Participants
n=24 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat (ITT) analysis set included all participants randomly assigned to study intervention. For this outcome measure (OM), data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment.
IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting.95 percentage (%)confidence interval was based on Blyth-Still-Casella method.
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=44 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) Only
|
—
|
—
|
—
|
11.4 Percentage of participants
Interval 4.6 to 24.4
|
23.8 Percentage of participants
Interval 12.1 to 38.7
|
21.4 Percentage of participants
Interval 11.4 to 36.4
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: ITT analysis set included all participants randomly assigned to study intervention. For this OM, data collection was not planned for the 3 arms of AD Vehicle QD, AD PF-07038124 0.01% QD and AD PF-07038124 0.03% QD.
The 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 (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). In this OM, percentages of participants with a PGA score of 0 or 1 and an improvement of \>=2 from Baseline in PGA score were reported. 95% confidence interval (CI) was based on Blyth-Still-Casella method.
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=34 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=33 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=35 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Week 12: Participants With Plaque Psoriasis Only
|
45.5 Percentage of participants
Interval 28.1 to 62.2
|
—
|
—
|
8.8 Percentage of participants
Interval 2.4 to 22.2
|
15.2 Percentage of participants
Interval 6.2 to 30.8
|
37.1 Percentage of participants
Interval 21.5 to 55.1
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 10 and 12Population: ITT analysis set included all participants randomly assigned to study intervention. For this OM, data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment.
EASI quantified severity of AD based on severity of lesion clinical signs and % of body surface area(BSA)affected.Severity of clinical signs of AD lesions (erythema \[E\], induration/papulation\[I\],excoriation\[Ex\] and lichenification\[L\]) were scored separately for each of 4 body regions(head and neck, upper limbs, trunk \[including axillae and groin)\], lower limbs \[including buttocks\]) on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe.EASI area score was based on % BSA with AD in body region: 0(0%), 1(\>0 to \<10%),2 (10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%) and 6(90 to 100%).Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu)+0.3\*At\*(Et+It+Ext+Lt)+0.4\*Al\*(El+Il+Exl+Ll);A= EASI area score;h= head and neck;u= upper limbs;t= trunk;l= lower limbs.Total EASI score=0.0 to 72.0, higher scores indicate greater severity of AD.EASI 75 response was defined as at least a 75% reduction in EASI relative to Baseline.95% CI was based on Blyth-Still-Casella method.
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=44 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis Only
Week 6
|
—
|
—
|
—
|
13.6 Percentage of participants
Interval 6.1 to 26.3
|
21.4 Percentage of participants
Interval 11.4 to 36.4
|
16.7 Percentage of participants
Interval 7.5 to 30.0
|
—
|
|
Percentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis Only
Week 8
|
—
|
—
|
—
|
15.9 Percentage of participants
Interval 7.2 to 29.0
|
19.0 Percentage of participants
Interval 8.9 to 33.5
|
14.3 Percentage of participants
Interval 6.4 to 27.7
|
—
|
|
Percentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis Only
Week 12
|
—
|
—
|
—
|
13.6 Percentage of participants
Interval 6.1 to 26.3
|
26.2 Percentage of participants
Interval 14.9 to 41.0
|
28.6 Percentage of participants
Interval 15.7 to 43.3
|
—
|
|
Percentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis Only
Week 1
|
—
|
—
|
—
|
2.3 Percentage of participants
Interval 0.1 to 11.5
|
2.4 Percentage of participants
Interval 0.1 to 12.1
|
4.8 Percentage of participants
Interval 0.9 to 15.7
|
—
|
|
Percentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis Only
Week 2
|
—
|
—
|
—
|
2.3 Percentage of participants
Interval 0.1 to 11.5
|
11.9 Percentage of participants
Interval 4.8 to 25.3
|
7.1 Percentage of participants
Interval 2.0 to 18.7
|
—
|
|
Percentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis Only
Week 4
|
—
|
—
|
—
|
11.4 Percentage of participants
Interval 4.6 to 24.4
|
11.9 Percentage of participants
Interval 4.8 to 25.3
|
16.7 Percentage of participants
Interval 7.5 to 30.0
|
—
|
|
Percentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis Only
Week 10
|
—
|
—
|
—
|
13.6 Percentage of participants
Interval 6.1 to 26.3
|
21.4 Percentage of participants
Interval 11.4 to 36.4
|
19.0 Percentage of participants
Interval 8.9 to 33.5
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 10 and 12Population: ITT analysis set included all participants randomly assigned to study intervention. For this OM, data collection was not planned for the 3 arms of AD Vehicle QD, AD PF-07038124 0.01% QD and AD PF-07038124 0.03% QD.
The PASI quantified the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score could vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI score =0.1Ah(Eh+Ih+Sh) + 0.2Au(Eu+Iu+Su) + 0.3At(Et+It+St) + 0.4Al(El+Il+Sl) (A= PASI area score,S=scaling)PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. 95% confidence interval was based on Blyth-Still-Casella method.
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=34 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=33 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=35 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis Only
Week 1
|
9.1 Percentage of participants
Interval 2.5 to 22.9
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 9.0
|
3.0 Percentage of participants
Interval 0.2 to 15.6
|
0 Percentage of participants
Interval 0.0 to 8.7
|
—
|
|
Percentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis Only
Week 2
|
15.2 Percentage of participants
Interval 6.2 to 30.8
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 9.0
|
9.1 Percentage of participants
Interval 2.5 to 22.9
|
2.9 Percentage of participants
Interval 0.1 to 14.6
|
—
|
|
Percentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis Only
Week 6
|
33.3 Percentage of participants
Interval 19.2 to 51.8
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 9.0
|
21.2 Percentage of participants
Interval 9.2 to 37.8
|
22.9 Percentage of participants
Interval 11.0 to 39.4
|
—
|
|
Percentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis Only
Week 8
|
33.3 Percentage of participants
Interval 19.2 to 51.8
|
—
|
—
|
2.9 Percentage of participants
Interval 0.2 to 15.1
|
18.2 Percentage of participants
Interval 8.2 to 33.8
|
25.7 Percentage of participants
Interval 13.8 to 42.1
|
—
|
|
Percentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis Only
Week 10
|
48.5 Percentage of participants
Interval 30.8 to 66.2
|
—
|
—
|
8.8 Percentage of participants
Interval 2.4 to 22.2
|
30.3 Percentage of participants
Interval 15.6 to 48.2
|
28.6 Percentage of participants
Interval 14.6 to 44.9
|
—
|
|
Percentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis Only
Week 4
|
21.2 Percentage of participants
Interval 9.2 to 37.8
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 9.0
|
15.2 Percentage of participants
Interval 6.2 to 30.8
|
14.3 Percentage of participants
Interval 5.8 to 28.8
|
—
|
|
Percentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis Only
Week 12
|
51.5 Percentage of participants
Interval 33.8 to 69.2
|
—
|
—
|
14.7 Percentage of participants
Interval 6.0 to 29.8
|
27.3 Percentage of participants
Interval 14.7 to 45.1
|
25.7 Percentage of participants
Interval 13.8 to 42.1
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, and 10Population: ITT analysis set included all participants randomly assigned to study intervention. For this outcome measure (OM), data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment.
IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting.95%confidence interval was based on Blyth-Still-Casella method.
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=44 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis Only
Week 1
|
—
|
—
|
—
|
2.3 Percentage of participants
Interval 0.1 to 11.5
|
4.8 Percentage of participants
Interval 0.9 to 15.7
|
4.8 Percentage of participants
Interval 0.9 to 15.7
|
—
|
|
Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis Only
Week 10
|
—
|
—
|
—
|
11.4 Percentage of participants
Interval 4.6 to 24.4
|
19.0 Percentage of participants
Interval 8.9 to 33.5
|
14.3 Percentage of participants
Interval 6.4 to 27.7
|
—
|
|
Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis Only
Week 2
|
—
|
—
|
—
|
2.3 Percentage of participants
Interval 0.1 to 11.5
|
7.1 Percentage of participants
Interval 2.0 to 18.7
|
9.5 Percentage of participants
Interval 3.3 to 21.6
|
—
|
|
Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis Only
Week 4
|
—
|
—
|
—
|
9.1 Percentage of participants
Interval 3.2 to 20.5
|
14.3 Percentage of participants
Interval 6.4 to 27.7
|
11.9 Percentage of participants
Interval 4.8 to 25.3
|
—
|
|
Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis Only
Week 6
|
—
|
—
|
—
|
6.8 Percentage of participants
Interval 1.9 to 18.6
|
14.3 Percentage of participants
Interval 6.4 to 27.7
|
14.3 Percentage of participants
Interval 6.4 to 27.7
|
—
|
|
Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis Only
Week 8
|
—
|
—
|
—
|
6.8 Percentage of participants
Interval 1.9 to 18.6
|
16.7 Percentage of participants
Interval 7.5 to 30.0
|
9.5 Percentage of participants
Interval 3.3 to 21.6
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, and 10Population: ITT analysis set included all participants randomly assigned to study intervention. For this OM, data collection was not planned for the 3 arms of AD Vehicle QD, AD PF-07038124 0.01% QD and AD PF-07038124 0.03% QD.
The 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 (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). In this OM, percentages of participants with a PGA score of 0 or 1 and an improvement of \>=2 from Baseline in PGA score were reported. 95% confidence interval was based on Blyth-Still-Casella method.
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=34 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=33 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=35 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis Only
Week 1
|
3.0 Percentage of participants
Interval 0.2 to 15.6
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 9.0
|
0 Percentage of participants
Interval 0.0 to 9.2
|
0 Percentage of participants
Interval 0.0 to 8.7
|
—
|
|
Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis Only
Week 6
|
24.2 Percentage of participants
Interval 11.7 to 42.1
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 9.0
|
15.2 Percentage of participants
Interval 6.2 to 30.8
|
17.1 Percentage of participants
Interval 7.7 to 32.5
|
—
|
|
Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis Only
Week 2
|
9.1 Percentage of participants
Interval 2.5 to 22.9
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 9.0
|
6.1 Percentage of participants
Interval 1.1 to 19.2
|
5.7 Percentage of participants
Interval 1.0 to 18.8
|
—
|
|
Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis Only
Week 4
|
15.2 Percentage of participants
Interval 6.2 to 30.8
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 9.0
|
6.1 Percentage of participants
Interval 1.1 to 19.2
|
17.1 Percentage of participants
Interval 7.7 to 32.5
|
—
|
|
Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis Only
Week 8
|
27.3 Percentage of participants
Interval 14.7 to 45.1
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 9.0
|
9.1 Percentage of participants
Interval 2.5 to 22.9
|
28.6 Percentage of participants
Interval 14.6 to 44.9
|
—
|
|
Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis Only
Week 10
|
39.4 Percentage of participants
Interval 22.9 to 57.9
|
—
|
—
|
5.9 Percentage of participants
Interval 1.1 to 18.8
|
15.2 Percentage of participants
Interval 6.2 to 30.8
|
31.4 Percentage of participants
Interval 18.2 to 47.8
|
—
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 6, 8, 10 and 12Population: ITT analysis set included all participants randomly assigned to study intervention. For this outcome measure (OM), data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment.
IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting. 95% confidence interval was based on Blyth-Still-Casella method.
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=44 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 1
|
—
|
—
|
—
|
2.3 Percentage of participants
Interval 0.1 to 11.5
|
4.8 Percentage of participants
Interval 0.9 to 15.7
|
4.8 Percentage of participants
Interval 0.9 to 15.7
|
—
|
|
Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 2
|
—
|
—
|
—
|
4.5 Percentage of participants
Interval 0.8 to 15.0
|
7.1 Percentage of participants
Interval 2.0 to 18.7
|
11.9 Percentage of participants
Interval 4.8 to 25.3
|
—
|
|
Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 4
|
—
|
—
|
—
|
11.4 Percentage of participants
Interval 4.6 to 24.4
|
16.7 Percentage of participants
Interval 7.5 to 30.0
|
19.0 Percentage of participants
Interval 8.9 to 33.5
|
—
|
|
Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 6
|
—
|
—
|
—
|
9.1 Percentage of participants
Interval 3.2 to 20.5
|
14.3 Percentage of participants
Interval 6.4 to 27.7
|
21.4 Percentage of participants
Interval 11.4 to 36.4
|
—
|
|
Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 8
|
—
|
—
|
—
|
11.4 Percentage of participants
Interval 4.6 to 24.4
|
16.7 Percentage of participants
Interval 7.5 to 30.0
|
16.7 Percentage of participants
Interval 7.5 to 30.0
|
—
|
|
Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 10
|
—
|
—
|
—
|
15.9 Percentage of participants
Interval 7.2 to 29.0
|
19.0 Percentage of participants
Interval 8.9 to 33.5
|
19.0 Percentage of participants
Interval 8.9 to 33.5
|
—
|
|
Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 12
|
—
|
—
|
—
|
15.9 Percentage of participants
Interval 7.2 to 29.0
|
23.8 Percentage of participants
Interval 12.1 to 38.7
|
28.6 Percentage of participants
Interval 15.7 to 43.3
|
—
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 6, 8, 10 and 12Population: ITT analysis set included all participants randomly assigned to study intervention. For this OM, data collection was not planned for the 3 arms of AD Vehicle QD, AD PF-07038124 0.01% QD and AD PF-07038124 0.03% QD.
The 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 (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). 95% confidence interval was based on Blyth-Still-Casella method.
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=34 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=33 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=35 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 4
|
15.2 Percentage of participants
Interval 6.2 to 30.8
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 9.0
|
6.1 Percentage of participants
Interval 1.1 to 19.2
|
17.1 Percentage of participants
Interval 7.7 to 32.5
|
—
|
|
Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 1
|
3.0 Percentage of participants
Interval 0.2 to 15.6
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 9.0
|
0 Percentage of participants
Interval 0.0 to 9.2
|
2.9 Percentage of participants
Interval 0.1 to 14.6
|
—
|
|
Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 2
|
9.1 Percentage of participants
Interval 2.5 to 22.9
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 9.0
|
6.1 Percentage of participants
Interval 1.1 to 19.2
|
5.7 Percentage of participants
Interval 1.0 to 18.8
|
—
|
|
Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 6
|
24.2 Percentage of participants
Interval 11.7 to 42.1
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 9.0
|
15.2 Percentage of participants
Interval 6.2 to 30.8
|
17.1 Percentage of participants
Interval 7.7 to 32.5
|
—
|
|
Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 8
|
27.3 Percentage of participants
Interval 14.7 to 45.1
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 9.0
|
9.1 Percentage of participants
Interval 2.5 to 22.9
|
28.6 Percentage of participants
Interval 14.6 to 44.9
|
—
|
|
Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 10
|
39.4 Percentage of participants
Interval 22.9 to 57.9
|
—
|
—
|
8.8 Percentage of participants
Interval 2.4 to 22.2
|
15.2 Percentage of participants
Interval 6.2 to 30.8
|
34.3 Percentage of participants
Interval 19.1 to 52.2
|
—
|
|
Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 12
|
45.5 Percentage of participants
Interval 28.1 to 62.2
|
—
|
—
|
11.8 Percentage of participants
Interval 4.1 to 27.2
|
15.2 Percentage of participants
Interval 6.2 to 30.8
|
40.0 Percentage of participants
Interval 25.0 to 57.9
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 10 and 12Population: ITT analysis set included all participants randomly assigned to study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified rows. For this OM, data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment.
EASI quantified severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\] and lichenification \[L\]) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score=0.0 to 72.0, higher scores indicate greater severity of AD. 95% confidence interval was based on Blyth-Still-Casella method.
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=44 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 1
|
—
|
—
|
—
|
-10.07 Percent change
Standard Deviation 35.340
|
-24.58 Percent change
Standard Deviation 26.168
|
-21.07 Percent change
Standard Deviation 27.609
|
—
|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 2
|
—
|
—
|
—
|
-20.10 Percent change
Standard Deviation 35.277
|
-35.91 Percent change
Standard Deviation 28.570
|
-35.35 Percent change
Standard Deviation 30.467
|
—
|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 4
|
—
|
—
|
—
|
-31.06 Percent change
Standard Deviation 37.602
|
-47.23 Percent change
Standard Deviation 28.432
|
-46.43 Percent change
Standard Deviation 29.199
|
—
|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 6
|
—
|
—
|
—
|
-33.89 Percent change
Standard Deviation 41.636
|
-47.89 Percent change
Standard Deviation 34.117
|
-51.96 Percent change
Standard Deviation 32.322
|
—
|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 8
|
—
|
—
|
—
|
-33.85 Percent change
Standard Deviation 41.950
|
-53.67 Percent change
Standard Deviation 30.285
|
-53.44 Percent change
Standard Deviation 29.639
|
—
|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 10
|
—
|
—
|
—
|
-41.88 Percent change
Standard Deviation 39.244
|
55.70 Percent change
Standard Deviation 29.250
|
-53.34 Percent change
Standard Deviation 35.171
|
—
|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 12
|
—
|
—
|
—
|
-36.05 Percent change
Standard Deviation 50.080
|
-58.40 Percent change
Standard Deviation 29.835
|
-53.29 Percent change
Standard Deviation 38.096
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 10 and 12Population: ITT analysis set included all participants randomly assigned to study intervention. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows. For this OM, data collection was not planned for the 3 arms of AD Vehicle QD, AD PF-07038124 0.01% QD and AD PF-07038124 0.03% QD.
The PASI quantified the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score could vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI =0.1Ah(Eh+Ih+Sh) + 0.2Au(Eu+Iu+Su) + 0.3At(Et+It+St) + 0.4Al(El+Il+Sl) (A= PASI area score,S=scaling)PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. 95% confidence interval was based on Blyth-Still-Casella method.
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=34 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=33 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=35 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 10
|
-5.74 Units on a scale
Standard Deviation 3.973
|
—
|
—
|
-3.93 Units on a scale
Standard Deviation 3.398
|
-4.45 Units on a scale
Standard Deviation 3.486
|
-4.87 Units on a scale
Standard Deviation 3.369
|
—
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 12
|
-6.07 Units on a scale
Standard Deviation 4.058
|
—
|
—
|
-3.57 Units on a scale
Standard Deviation 3.946
|
-4.53 Units on a scale
Standard Deviation 3.556
|
-4.84 Units on a scale
Standard Deviation 3.530
|
—
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 1
|
-2.66 Units on a scale
Standard Deviation 2.064
|
—
|
—
|
-0.60 Units on a scale
Standard Deviation 1.796
|
-1.74 Units on a scale
Standard Deviation 1.529
|
-1.69 Units on a scale
Standard Deviation 2.053
|
—
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 2
|
-3.84 Units on a scale
Standard Deviation 3.357
|
—
|
—
|
-1.53 Units on a scale
Standard Deviation 2.192
|
-2.75 Units on a scale
Standard Deviation 2.315
|
-2.41 Units on a scale
Standard Deviation 2.496
|
—
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 4
|
-4.77 Units on a scale
Standard Deviation 3.694
|
—
|
—
|
-1.70 Units on a scale
Standard Deviation 3.245
|
-3.09 Units on a scale
Standard Deviation 2.332
|
-3.50 Units on a scale
Standard Deviation 2.861
|
—
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 6
|
-5.39 Units on a scale
Standard Deviation 3.797
|
—
|
—
|
-2.13 Units on a scale
Standard Deviation 3.451
|
-3.65 Units on a scale
Standard Deviation 2.639
|
-4.54 Units on a scale
Standard Deviation 3.143
|
—
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 8
|
-6.51 Units on a scale
Standard Deviation 4.002
|
—
|
—
|
-3.23 Units on a scale
Standard Deviation 3.584
|
-3.70 Units on a scale
Standard Deviation 3.059
|
-4.73 Units on a scale
Standard Deviation 3.383
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 10 and 12Population: ITT analysis set included all participants randomly assigned to study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. For this outcome measure (OM), data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment.
The PP-NRS was a daily participant reported assessment of intensity of pruritus on an 11-point numerical rating scale ranging from 0 ('No Itch) to 10 ('Worst Itch Imaginable'), with a 24-hour recall period. 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. For the PP-NRS score, baseline was defined as the average of all values recorded between Day -7 (7 days prior to dosing) and Day -1 (1 day prior to dosing). In this OM, percentages of AD participants with \>=4 points of reduction in weekly averages of PP-NRS from baseline are reported (percentage based on number of participants with baseline \>=4).
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=40 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=38 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=34 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 2
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 7.8
|
18.4 Percentage of participants
Interval 8.1 to 33.4
|
14.7 Percentage of participants
Interval 6.0 to 29.8
|
—
|
|
Percentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 6
|
—
|
—
|
—
|
17.5 Percentage of participants
Interval 7.8 to 31.5
|
21.1 Percentage of participants
Interval 10.0 to 35.8
|
26.5 Percentage of participants
Interval 14.3 to 43.6
|
—
|
|
Percentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 1
|
—
|
—
|
—
|
2.5 Percentage of participants
Interval 0.1 to 12.7
|
5.3 Percentage of participants
Interval 0.9 to 17.5
|
0 Percentage of participants
Interval 0.0 to 9.0
|
—
|
|
Percentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 4
|
—
|
—
|
—
|
10.0 Percentage of participants
Interval 3.5 to 22.7
|
23.7 Percentage of participants
Interval 12.7 to 38.9
|
29.4 Percentage of participants
Interval 15.1 to 46.5
|
—
|
|
Percentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 8
|
—
|
—
|
—
|
17.5 Percentage of participants
Interval 7.8 to 31.5
|
21.1 Percentage of participants
Interval 10.0 to 35.8
|
29.4 Percentage of participants
Interval 15.1 to 46.5
|
—
|
|
Percentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 10
|
—
|
—
|
—
|
17.5 Percentage of participants
Interval 7.8 to 31.5
|
23.7 Percentage of participants
Interval 12.7 to 38.9
|
26.5 Percentage of participants
Interval 14.3 to 43.6
|
—
|
|
Percentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
Week 12
|
—
|
—
|
—
|
15.0 Percentage of participants
Interval 6.7 to 29.3
|
26.3 Percentage of participants
Interval 13.4 to 42.1
|
35.3 Percentage of participants
Interval 20.0 to 53.5
|
—
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 6, 8, 10 and 12Population: ITT analysis set included all participants randomly assigned to study intervention.Here,'Overall Number of Participants Analyzed'=participants evaluable for this OM,all participants reported under'Overall Number of Participants Analyzed'contributed data to table but may not have evaluable data for every row.Here,'Number Analyzed'=participants evaluable for specified rows.For this OM,data collection was not planned for 3 arms:AD Vehicle QD, PF-07038124 0.01% QD,AD PF-07038124 0.03% QD ointment.
The PP-NRS was a daily participant reported assessment of intensity of pruritus on an 11-point numerical rating scale ranging from 0 ('No Itch) to 10 ('Worst Itch Imaginable'), with a 24-hour recall period. 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. For the PP-NRS score, baseline was defined as the average of all values recorded between Day -7 (7 days prior to dosing) and Day -1 (1 day prior to dosing). In this OM, percentages of plaque psoriasis participants (18-75 years old) with \>=4 points of reduction in weekly averages of PP-NRS from baseline are reported (percentage based on number of participants with baseline \>=4).
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
n=31 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=33 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=33 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=31 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 1
|
5.3 Percentage of participants
Interval 0.3 to 24.4
|
—
|
—
|
4.3 Percentage of participants
Interval 0.2 to 19.8
|
0 Percentage of participants
Interval 0.0 to 13.9
|
12.5 Percentage of participants
Interval 3.5 to 30.8
|
—
|
|
Percentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 2
|
21.1 Percentage of participants
Interval 7.5 to 43.4
|
—
|
—
|
4.3 Percentage of participants
Interval 0.2 to 19.8
|
13.6 Percentage of participants
Interval 3.8 to 32.6
|
20.8 Percentage of participants
Interval 8.6 to 40.6
|
—
|
|
Percentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 4
|
26.3 Percentage of participants
Interval 11.0 to 50.0
|
—
|
—
|
8.7 Percentage of participants
Interval 1.6 to 26.8
|
22.7 Percentage of participants
Interval 9.4 to 45.1
|
25.0 Percentage of participants
Interval 11.5 to 44.7
|
—
|
|
Percentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 6
|
42.1 Percentage of participants
Interval 22.2 to 65.5
|
—
|
—
|
4.3 Percentage of participants
Interval 0.2 to 19.8
|
31.8 Percentage of participants
Interval 13.9 to 54.9
|
25.0 Percentage of participants
Interval 11.5 to 44.7
|
—
|
|
Percentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 8
|
52.6 Percentage of participants
Interval 31.2 to 75.6
|
—
|
—
|
17.4 Percentage of participants
Interval 6.2 to 38.5
|
40.9 Percentage of participants
Interval 20.7 to 61.7
|
25.0 Percentage of participants
Interval 11.5 to 44.7
|
—
|
|
Percentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 10
|
47.4 Percentage of participants
Interval 24.4 to 68.8
|
—
|
—
|
17.4 Percentage of participants
Interval 6.2 to 38.5
|
36.4 Percentage of participants
Interval 18.7 to 58.2
|
29.2 Percentage of participants
Interval 12.6 to 50.0
|
—
|
|
Percentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
Week 12
|
47.4 Percentage of participants
Interval 24.4 to 68.8
|
—
|
—
|
17.4 Percentage of participants
Interval 6.2 to 38.5
|
40.9 Percentage of participants
Interval 20.7 to 61.7
|
33.3 Percentage of participants
Interval 16.9 to 55.3
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 10 and 12Population: ITT analysis set included all participants randomly assigned to study intervention. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall percentage (%) BSA for individuals with AD ranged from 5-40 % BSA and for individuals with Psoriasis ranged from 2-20 % BSA. Higher % BSA = greater area affected.
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
n=34 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
n=35 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=44 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque Psoriasis
Week 1
|
-0.57 Percent change
Standard Deviation 3.095
|
-11.80 Percent change
Standard Deviation 22.429
|
-4.08 Percent change
Standard Deviation 24.592
|
-5.70 Percent change
Standard Deviation 21.189
|
-7.97 Percent change
Standard Deviation 20.319
|
-11.34 Percent change
Standard Deviation 27.214
|
-11.24 Percent change
Standard Deviation 23.946
|
|
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque Psoriasis
Week 2
|
-0.09 Percent change
Standard Deviation 19.604
|
-20.88 Percent change
Standard Deviation 30.731
|
-9.60 Percent change
Standard Deviation 31.828
|
-7.71 Percent change
Standard Deviation 38.699
|
-19.19 Percent change
Standard Deviation 26.809
|
-25.17 Percent change
Standard Deviation 33.618
|
-20.62 Percent change
Standard Deviation 26.613
|
|
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque Psoriasis
Week 4
|
3.14 Percent change
Standard Deviation 27.814
|
-24.40 Percent change
Standard Deviation 33.837
|
-23.27 Percent change
Standard Deviation 33.581
|
-23.51 Percent change
Standard Deviation 42.066
|
-30.05 Percent change
Standard Deviation 32.224
|
-36.52 Percent change
Standard Deviation 36.063
|
-33.16 Percent change
Standard Deviation 32.929
|
|
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque Psoriasis
Week 6
|
1.19 Percent change
Standard Deviation 23.562
|
-36.37 Percent change
Standard Deviation 37.798
|
-30.76 Percent change
Standard Deviation 33.598
|
-20.81 Percent change
Standard Deviation 38.584
|
-33.20 Percent change
Standard Deviation 37.302
|
-41.40 Percent change
Standard Deviation 39.631
|
-44.91 Percent change
Standard Deviation 38.196
|
|
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque Psoriasis
Week 8
|
0.75 Percent change
Standard Deviation 30.196
|
-31.98 Percent change
Standard Deviation 47.562
|
-34.04 Percent change
Standard Deviation 38.481
|
-21.12 Percent change
Standard Deviation 49.459
|
-35.81 Percent change
Standard Deviation 34.333
|
-43.59 Percent change
Standard Deviation 39.783
|
-51.30 Percent change
Standard Deviation 39.210
|
|
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque Psoriasis
Week 10
|
-3.77 Percent change
Standard Deviation 26.271
|
-42.72 Percent change
Standard Deviation 47.305
|
36.35 Percent change
Standard Deviation 38.176
|
-27.68 Percent change
Standard Deviation 44.681
|
-36.84 Percent change
Standard Deviation 36.966
|
-36.38 Percent change
Standard Deviation 50.533
|
-49.14 Percent change
Standard Deviation 38.319
|
|
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque Psoriasis
Week 12
|
-7.61 Percent change
Standard Deviation 42.825
|
-38.16 Percent change
Standard Deviation 48.923
|
-36.13 Percent change
Standard Deviation 39.779
|
-19.45 Percent change
Standard Deviation 48.697
|
-40.87 Percent change
Standard Deviation 41.005
|
-46.53 Percent change
Standard Deviation 44.420
|
-60.83 Percent change
Standard Deviation 39.223
|
SECONDARY outcome
Timeframe: From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)Population: Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered TEAE if the event occurred on or after the first dosing date but before the last dose plus the lag time (35 days).
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
n=34 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
n=35 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=44 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis
|
9 Participants
|
13 Participants
|
11 Participants
|
20 Participants
|
28 Participants
|
19 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)Population: Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention.
An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other important medical events.
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
n=34 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
n=35 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=44 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment (Day 1) up to Week 12Population: Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention.
Temperature, pulse rate, and blood pressure were assessed in vital sign examination. Body temperature was collected using oral, tympanic, axillary or temporal methods. Blood pressure and pulse rate measurements were assessed with the participant in a supine or seated position using a completely automated device after at least 5 minutes of rest for the participant. Clinically significant changes were determined by the investigator.
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
n=34 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
n=35 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=44 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment (Day 1) up to Week 12Population: Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention.
A standard 12-lead ECG utilizing limb leads was collected using ECG machine that automatically calculated the heart rate and measured pulse rate, QT, and QTc intervals and QRS complex. Clinically significant findings (including, but not limited to, changes from baseline in QTcF after enrollment) were determined by the investigator or qualified designee.
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
n=34 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
n=35 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=44 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment (Day 1) up to Week 12Population: Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention.
Laboratory assessments included hematology, clinical chemistry and urinalysis. Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
n=34 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
n=35 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=44 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis
|
14 Participants
|
14 Participants
|
13 Participants
|
18 Participants
|
27 Participants
|
18 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment (Day 1) up to Week 12Population: Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention.
The investigator or designee assessed tolerability at the site of study intervention application, immediately post-application of the study intervention. Skin Tolerability Grading System for non-lesional skin included grade 0 (No evidence of local intolerance), grade 1 (Mild-Minimal erythema and/or edema, slight glazed appearance), grade 2 (Moderate-Definite erythema and/or edema with peeling and/or cracking but needs no adaptation of posology), grade 3 (Severe-Erythema, edema glazing with fissures, few vesicles or papules: consider removing topical agent \[if still in place\], grade 4 (very severe- Strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent \[if still in place\].
Outcome measures
| Measure |
Psoriasis: PF-07038124 Vehicle Ointment
n=34 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
n=35 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: Vehicle Ointment
n=44 Participants
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=42 Participants
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
n=33 Participants
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis
Grade 2 (Moderate)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis
Grade 0 (None)
|
32 Participants
|
32 Participants
|
34 Participants
|
44 Participants
|
42 Participants
|
42 Participants
|
33 Participants
|
|
Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis
Grade 1 (Mild)
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis
Grade 3 (Severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis
Grade 4 (Very severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis
Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Atopic Dermatitis: Vehicle Ointment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Atopic Dermatitis: PF-07038124 0.01% Ointment
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Atopic Dermatitis: PF-07038124 0.03% Ointment
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Psoriasis: PF-07038124 Vehicle Ointment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Psoriasis: PF-07038124 0.01% Ointment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Psoriasis: PF-07038124 0.03% Ointment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Psoriasis: PF-07038124 0.06% Ointment
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atopic Dermatitis: Vehicle Ointment
n=44 participants at risk
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=42 participants at risk
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=42 participants at risk
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 Vehicle Ointment
n=34 participants at risk
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
n=33 participants at risk
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
n=35 participants at risk
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
n=33 participants at risk
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/44 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/34 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/33 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/33 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/44 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/34 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/33 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.0%
1/33 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/44 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/34 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/33 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/33 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Atopic Dermatitis: Vehicle Ointment
n=44 participants at risk
Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.01% Ointment
n=42 participants at risk
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Atopic Dermatitis: PF-07038124 0.03% Ointment
n=42 participants at risk
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 Vehicle Ointment
n=34 participants at risk
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.01% Ointment
n=33 participants at risk
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.03% Ointment
n=35 participants at risk
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks.
|
Psoriasis: PF-07038124 0.06% Ointment
n=33 participants at risk
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/44 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/34 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.1%
2/33 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.7%
2/35 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
3/33 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/44 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
11.9%
5/42 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
4.8%
2/42 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.9%
1/34 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.0%
1/33 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.1%
2/33 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/44 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/34 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.1%
2/33 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/33 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/44 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/34 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/33 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.1%
2/33 • From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
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 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