Trial Outcomes & Findings for Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis (NCT NCT04664153)

Last Updated: 2022-08-26

Results Overview

EASI evaluated severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % 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; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

104 participants

Primary outcome timeframe

Baseline, Week 6

Results posted on

2022-08-26

Participant Flow

A total of 152 participants were screened for this study and 104 participants were assigned to study treatment (70 for atopic dermatitis \[AD\] group and 34 for plaque psoriasis group).

Participant milestones

Participant milestones
Measure	AD Vehicle Once Daily (QD) Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Overall Study STARTED	34	36	17	17
Overall Study COMPLETED	27	33	13	15
Overall Study NOT COMPLETED	7	3	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	AD Vehicle Once Daily (QD) Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Overall Study Lack of Efficacy	0	0	1	0
Overall Study Physician Decision	0	0	1	0
Overall Study Withdrawal by Subject	3	2	1	2
Overall Study Other	0	1	0	0
Overall Study Adverse Event	4	0	1	0

Baseline Characteristics

Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AD Vehicle Once Daily (QD) n=34 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=36 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD n=17 Participants Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD n=17 Participants Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Total n=104 Participants Total of all reporting groups
Age, Continuous Mean	36.1 Years STANDARD_DEVIATION 13.93 • n=5 Participants	41.4 Years STANDARD_DEVIATION 16.61 • n=7 Participants	51.2 Years STANDARD_DEVIATION 10.83 • n=5 Participants	51.8 Years STANDARD_DEVIATION 12.32 • n=4 Participants	43.0 Years STANDARD_DEVIATION 15.44 • n=21 Participants
Age, Customized 18-44 years	25 Participants n=5 Participants	23 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	56 Participants n=21 Participants
Age, Customized 45-64 years	9 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	10 Participants n=4 Participants	39 Participants n=21 Participants
Age, Customized >=65 years	0 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	55 Participants n=21 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	16 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	49 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	31 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	25 Participants n=7 Participants	10 Participants n=5 Participants	12 Participants n=4 Participants	73 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized White	25 Participants n=5 Participants	29 Participants n=7 Participants	17 Participants n=5 Participants	16 Participants n=4 Participants	87 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	13 Participants n=21 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 6

Population: Analysis population included all participants who received at least 1 dose of study treatment. For this outcome measure (OM), data collection was not planned for the 2 arms of Psoriasis Vehicle QD and Psoriasis PF-07038124 0.01% QD.

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=34 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=36 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 for AD Participants	-35.5 Percent Change Interval -48.95 to -22.03	-74.9 Percent Change Interval -88.81 to -61.06	—	—

PRIMARY outcome

Timeframe: Baseline, Week 6

Population: Analysis population included all participants who received at least 1 dose of study treatment. For this OM, data collection was not planned for the 2 arms of AD Vehicle QD and AD PF-07038124 0.01% QD.

Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease, where higher scores = greater severity of psoriasis.

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=17 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=17 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 6 for Plaque Psoriasis Participants	0.1 Units on a Scale Interval -1.47 to 1.68	-4.8 Units on a Scale Interval -6.21 to -3.37	—	—

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: Analysis population included all participants who received at least 1 dose of study treatment. For this OM, data collection was not planned for the 2 arms of Psoriasis Vehicle QD and Psoriasis PF-07038124 0.01% QD.

IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared-light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. In this OM, percentages of participants with an IGA score of 0 or 1 and a reduction of \>=2 from Baseline in IGA score are reported.

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=34 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=36 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Percentage of AD Participants Achieving Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) (on a 5-Point Scale) and a Reduction From Baseline of >=2 Points at Week 6	8.8 Percentage of Participants Interval 3.3 to 19.7	44.4 Percentage of Participants Interval 30.2 to 59.1	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

EASI evaluated severity of participants' AD based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % 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; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. EASI 75 response was defined as at least a 75 percent (%) reduction in EASI relative to Baseline.

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=34 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=36 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Percentage of AD Participants Achieving EASI 75 (75% Improvement From Baseline) at Weeks 1, 2, 4, 6 and Follow-up (FUP)/End of Study (EOS) Week 1	0 Percentage of Participants Interval 0.0 to 8.0	8.3 Percentage of Participants Interval 3.1 to 18.9	—	—
Percentage of AD Participants Achieving EASI 75 (75% Improvement From Baseline) at Weeks 1, 2, 4, 6 and Follow-up (FUP)/End of Study (EOS) Week 2	0 Percentage of Participants Interval 0.0 to 8.2	27.8 Percentage of Participants Interval 15.9 to 40.9	—	—
Percentage of AD Participants Achieving EASI 75 (75% Improvement From Baseline) at Weeks 1, 2, 4, 6 and Follow-up (FUP)/End of Study (EOS) Week 4	11.8 Percentage of Participants Interval 5.2 to 24.3	33.3 Percentage of Participants Interval 21.3 to 47.0	—	—
Percentage of AD Participants Achieving EASI 75 (75% Improvement From Baseline) at Weeks 1, 2, 4, 6 and Follow-up (FUP)/End of Study (EOS) Week 6	20.6 Percentage of Participants Interval 11.3 to 34.9	61.1 Percentage of Participants Interval 47.0 to 74.6	—	—
Percentage of AD Participants Achieving EASI 75 (75% Improvement From Baseline) at Weeks 1, 2, 4, 6 and Follow-up (FUP)/End of Study (EOS) FUP/EOS	8.8 Percentage of Participants Interval 3.3 to 19.7	44.4 Percentage of Participants Interval 30.2 to 59.1	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4 and 6

Population: Analysis population included all participants who received at least 1 dose of study treatment with PP-NRS baseline \>=4. For this OM, data collection was not planned for the 2 arms of Psoriasis Vehicle QD and Psoriasis PF-07038124 0.01% QD.

The PP-NRS was a daily patient-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. For the PP-NRS score, baseline was defined as the average of all values recorded between Day -7 and Day -1. 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

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=34 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=36 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Percentage of AD Participants Having >=4 Points of Reduction in Weekly Averages of Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 4 and 6 Week 6	13.8 Percentage of Participants Interval 6.2 to 27.9	41.2 Percentage of Participants Interval 26.9 to 56.7	—	—
Percentage of AD Participants Having >=4 Points of Reduction in Weekly Averages of Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 4 and 6 Week 1	0 Percentage of Participants Interval 0.0 to 9.4	8.8 Percentage of Participants Interval 3.3 to 19.7	—	—
Percentage of AD Participants Having >=4 Points of Reduction in Weekly Averages of Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 4 and 6 Week 2	3.4 Percentage of Participants Interval 0.4 to 14.5	23.5 Percentage of Participants Interval 12.3 to 37.7	—	—
Percentage of AD Participants Having >=4 Points of Reduction in Weekly Averages of Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 4 and 6 Week 4	6.9 Percentage of Participants Interval 1.8 to 20.0	41.2 Percentage of Participants Interval 26.9 to 56.7	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

EASI evaluated severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % 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; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=34 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=36 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Change From Baseline in EASI Total Score at Weeks 1, 2, 4, 6 and FUP/EOS for AD Participants Week 4	-2.5 Units on a Scale Interval -3.63 to -1.31	-7.0 Units on a Scale Interval -8.06 to -5.9	—	—
Change From Baseline in EASI Total Score at Weeks 1, 2, 4, 6 and FUP/EOS for AD Participants Week 6	-3.3 Units on a Scale Interval -4.59 to -1.93	-8.2 Units on a Scale Interval -9.39 to -6.94	—	—
Change From Baseline in EASI Total Score at Weeks 1, 2, 4, 6 and FUP/EOS for AD Participants FUP/EOS	-2.8 Units on a Scale Interval -4.26 to -1.39	-6.9 Units on a Scale Interval -8.19 to -5.54	—	—
Change From Baseline in EASI Total Score at Weeks 1, 2, 4, 6 and FUP/EOS for AD Participants Week 1	-1.7 Units on a Scale Interval -2.59 to -0.85	-3.4 Units on a Scale Interval -4.28 to -2.59	—	—
Change From Baseline in EASI Total Score at Weeks 1, 2, 4, 6 and FUP/EOS for AD Participants Week 2	-2.4 Units on a Scale Interval -3.42 to -1.45	-5.6 Units on a Scale Interval -6.51 to -4.66	—	—

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. In this OM, percentages of participants with an IGA score of 0 or 1 are reported.

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=34 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=36 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Percentage of AD Participants Achieving IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS Week 1	2.9 Percentage of Participants Interval 0.3 to 12.3	11.1 Percentage of Participants Interval 4.9 to 22.9	—	—
Percentage of AD Participants Achieving IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS Week 2	9.1 Percentage of Participants Interval 3.4 to 20.2	36.1 Percentage of Participants Interval 22.9 to 50.0	—	—
Percentage of AD Participants Achieving IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS Week 4	14.7 Percentage of Participants Interval 7.3 to 26.9	44.4 Percentage of Participants Interval 30.2 to 59.1	—	—
Percentage of AD Participants Achieving IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS Week 6	17.6 Percentage of Participants Interval 8.0 to 30.7	52.8 Percentage of Participants Interval 38.0 to 67.2	—	—
Percentage of AD Participants Achieving IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS FUP/EOS	5.9 Percentage of Participants Interval 1.6 to 16.9	38.9 Percentage of Participants Interval 25.4 to 53.0	—	—

SECONDARY outcome

Timeframe: Baseline, Week 6

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 are reported.

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=17 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=17 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Percentage of Psoriasis Participants With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) (on a 5-Point Scale) and >=2 Points Improvement From Baseline at Week 6	5.9 Percentage of Participants Interval 0.6 to 22.5	17.6 Percentage of Participants Interval 6.7 to 36.4	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

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 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=17 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=17 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Percentage of Psoriasis Participants Achieving PASI 75 (75% or Greater Improvement From Baseline) at Weeks 1, 2, 4, 6 and FUP/EOS Week 1	0 Percentage of Participants Interval 0.0 to 14.0	5.9 Percentage of Participants Interval 0.6 to 22.5	—	—
Percentage of Psoriasis Participants Achieving PASI 75 (75% or Greater Improvement From Baseline) at Weeks 1, 2, 4, 6 and FUP/EOS Week 2	0 Percentage of Participants Interval 0.0 to 14.0	5.9 Percentage of Participants Interval 0.6 to 22.5	—	—
Percentage of Psoriasis Participants Achieving PASI 75 (75% or Greater Improvement From Baseline) at Weeks 1, 2, 4, 6 and FUP/EOS Week 4	0 Percentage of Participants Interval 0.0 to 14.0	17.6 Percentage of Participants Interval 6.7 to 36.4	—	—
Percentage of Psoriasis Participants Achieving PASI 75 (75% or Greater Improvement From Baseline) at Weeks 1, 2, 4, 6 and FUP/EOS Week 6	5.9 Percentage of Participants Interval 0.6 to 22.5	35.3 Percentage of Participants Interval 17.5 to 56.8	—	—
Percentage of Psoriasis Participants Achieving PASI 75 (75% or Greater Improvement From Baseline) at Weeks 1, 2, 4, 6 and FUP/EOS FUP/EOS	0 Percentage of Participants Interval 0.0 to 14.0	23.5 Percentage of Participants Interval 10.7 to 43.2	—	—

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

PSI was a self-administered 8 item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure included concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Participants were asked to respond to each item using a 5 point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. In this OM, percentages of participants with a PSI score of 0 or 1 on every item at weeks 1, 2, 4, 6 and FUP/EOS are reported.

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=17 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=17 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Percentage of Psoriasis Participants Who Achieved a Psoriasis Symptoms Inventory (PSI) Score of 0 (Not at All) or 1 (Mild) on Every Item at Weeks 1, 2, 4, 6 and FUP/EOS Week 4	23.5 Percentage of Participants Interval 10.7 to 43.2	43.8 Percentage of Participants Interval 23.5 to 66.7	—	—
Percentage of Psoriasis Participants Who Achieved a Psoriasis Symptoms Inventory (PSI) Score of 0 (Not at All) or 1 (Mild) on Every Item at Weeks 1, 2, 4, 6 and FUP/EOS Week 1	0 Percentage of Participants Interval 0.0 to 14.0	11.8 Percentage of Participants Interval 3.2 to 31.1	—	—
Percentage of Psoriasis Participants Who Achieved a Psoriasis Symptoms Inventory (PSI) Score of 0 (Not at All) or 1 (Mild) on Every Item at Weeks 1, 2, 4, 6 and FUP/EOS Week 2	5.9 Percentage of Participants Interval 0.6 to 22.5	18.8 Percentage of Participants Interval 7.1 to 39.1	—	—
Percentage of Psoriasis Participants Who Achieved a Psoriasis Symptoms Inventory (PSI) Score of 0 (Not at All) or 1 (Mild) on Every Item at Weeks 1, 2, 4, 6 and FUP/EOS Week 6	29.4 Percentage of Participants Interval 14.0 to 50.0	58.8 Percentage of Participants Interval 36.4 to 77.5	—	—
Percentage of Psoriasis Participants Who Achieved a Psoriasis Symptoms Inventory (PSI) Score of 0 (Not at All) or 1 (Mild) on Every Item at Weeks 1, 2, 4, 6 and FUP/EOS FUP/EOS	41.2 Percentage of Participants Interval 22.5 to 63.6	41.2 Percentage of Participants Interval 22.5 to 63.6	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4 and FUP/EOS (28-35 days post-last dose)

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=17 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=17 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Change From Baseline in PASI Scores at Weeks 1, 2, 4 and FUP/EOS Week 1	-0.6 Units on a Scale Interval -1.23 to 0.03	-1.9 Units on a Scale Interval -2.5 to -1.24	—	—
Change From Baseline in PASI Scores at Weeks 1, 2, 4 and FUP/EOS Week 2	-0.7 Units on a Scale Interval -1.51 to 0.11	-3.2 Units on a Scale Interval -3.97 to -2.35	—	—
Change From Baseline in PASI Scores at Weeks 1, 2, 4 and FUP/EOS Week 4	-0.1 Units on a Scale Interval -1.49 to 1.19	-4.1 Units on a Scale Interval -5.44 to -2.8	—	—
Change From Baseline in PASI Scores at Weeks 1, 2, 4 and FUP/EOS FUP/EOS	0.2 Units on a Scale Interval -1.59 to 1.97	-3.7 Units on a Scale Interval -5.35 to -2.0	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=17 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=17 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6 and FUP/EOS Week 1	-6.8 Percent Change Interval -15.28 to 1.78	-25.6 Percent Change Interval -34.11 to -17.04	—	—
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6 and FUP/EOS Week 2	-9.0 Percent Change Interval -19.14 to 1.09	-37.8 Percent Change Interval -47.92 to -27.68	—	—
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6 and FUP/EOS Week 4	-9.0 Percent Change Interval -22.73 to 4.73	-49.4 Percent Change Interval -62.93 to -35.79	—	—
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6 and FUP/EOS Week 6	-5.4 Percent Change Interval -21.35 to 10.65	-58.1 Percent Change Interval -73.52 to -42.7	—	—
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6 and FUP/EOS FUP/EOS	-8.4 Percent Change Interval -27.02 to 10.25	-45.6 Percent Change Interval -63.02 to -28.1	—	—

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=17 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=17 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Percentage of Psoriasis Participants With PGA Score Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS FUP/EOS	11.8 Percentage of Participants Interval 3.2 to 31.1	17.6 Percentage of Participants Interval 6.7 to 36.4	—	—
Percentage of Psoriasis Participants With PGA Score Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS Week 1	0 Percentage of Participants Interval 0.0 to 14.0	11.8 Percentage of Participants Interval 3.2 to 31.1	—	—
Percentage of Psoriasis Participants With PGA Score Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS Week 2	0 Percentage of Participants Interval 0.0 to 14.0	17.6 Percentage of Participants Interval 6.7 to 36.4	—	—
Percentage of Psoriasis Participants With PGA Score Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS Week 4	0 Percentage of Participants Interval 0.0 to 14.0	23.5 Percentage of Participants Interval 10.7 to 43.2	—	—
Percentage of Psoriasis Participants With PGA Score Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS Week 6	5.9 Percentage of Participants Interval 0.6 to 22.5	23.5 Percentage of Participants Interval 10.7 to 43.2	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

Population: Analysis population included all participants who received at least 1 dose of study treatment.

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 % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=34 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=36 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD n=17 Participants Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD n=17 Participants Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6 and FUP/EOS Week 1	-6.6 Percent Change Interval -13.56 to 0.44	-20.2 Percent Change Interval -27.01 to -13.44	2.5 Percent Change Interval -5.5 to 10.49	-14.5 Percent Change Interval -22.46 to -6.56
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6 and FUP/EOS Week 2	-10.5 Percent Change Interval -19.71 to -1.27	-32.2 Percent Change Interval -40.83 to -23.62	7.2 Percent Change Interval -2.68 to 17.17	-13.8 Percent Change Interval -23.7 to -3.91
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6 and FUP/EOS Week 4	-2.9 Percent Change Interval -15.8 to 9.94	-43.9 Percent Change Interval -55.73 to -32.0	19.8 Percent Change Interval 3.8 to 35.79	-24.7 Percent Change Interval -40.52 to -8.89
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6 and FUP/EOS Week 6	-4.9 Percent Change Interval -23.07 to 13.28	-61.2 Percent Change Interval -78.01 to -44.42	29.0 Percent Change Interval 4.46 to 53.46	-32.6 Percent Change Interval -56.32 to -8.84
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6 and FUP/EOS FUP/EOS	-5.1 Percent Change Interval -20.7 to 10.56	-48.7 Percent Change Interval -63.05 to -34.27	15.8 Percent Change Interval -12.26 to 43.76	-31.9 Percent Change Interval -58.6 to -5.21

SECONDARY outcome

Timeframe: Day 1 through Week 6

Population: Analysis population included all participants who received at least 1 dose of study treatment.

An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=34 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=36 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD n=17 Participants Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD n=17 Participants Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Participants With All-Causality TEAEs	9 Participants	9 Participants	6 Participants	3 Participants
Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Participants With All-Causality SAEs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 through Week 6

Population: Analysis population included all participants evaluated against criteria.

Abnormality in vital signs: increase and decrease of change of supine diastolic blood pressure from baseline \>=20 mmHg, supine systolic blood pressure \<90 mmHg, and increase in change of supine systolic blood pressure from baseline \>=30 mmHg.

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=34 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=36 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD n=17 Participants Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD n=16 Participants Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria Change of Supine Diastolic Blood Pressure >=20 mmHg Increase	2 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria Change of Supine Diastolic Blood Pressure >=20 mmHg Decrease	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria Value of Supine Systolic Blood Pressure <90 mmHg	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria Change of Supine Systolic Blood Pressure >=30 mmHg Increase	1 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 through Week 6

Population: Analysis population included all participants evaluated against criteria.

ECG abnormalities criteria included: value of PR interval \>=300 msec, percent change of PR interval \>=25/50% and change of corrected QT interval using Fridericia's Formula (QTcF) \>=30 msec and \<60 msec.

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=27 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=33 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD n=13 Participants Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD n=15 Participants Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria Value of PR Interval >=300 msec	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria Percent Change of PR Interval >=25/50%	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria Change of Corrected QT Interval Using Fridericia's Formula (QTcF) >=30 msec and <60 msec	3 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1 through Week 6

Population: Analysis population included participants with at least 1 observation of the given laboratory test while on study treatment or during lag time.

Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test \[for all female participants\]) and urine (urine pregnancy test \[for all female participants\]).

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=34 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=36 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD n=17 Participants Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD n=17 Participants Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Number of Participants With Laboratory Test Abnormalities Hemoglobin <0.8 × LLN	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Lymphocytes >1.2 × ULN	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities URINE Erythrocytes (/HPF) >=20	2 Participants	1 Participants	0 Participants	3 Participants
Number of Participants With Laboratory Test Abnormalities Hyaline Casts (/LPF) >1	0 Participants	3 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Ery. Mean Corpuscular Volume <0.9 × LLN	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Ery. Mean Corpuscular Hemoglobin <0.9 × LLN	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Leukocytes >1.5 × ULN	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities Lymphocytes <0.8 × LLN	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Lymphocytes/Leukocytes <0.8 × LLN	3 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities Lymphocytes/Leukocytes >1.2 × ULN	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Neutrophils <0.8 × LLN	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Neutrophils >1.2 × ULN	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities Neutrophils/Leukocytes <0.8 × LLN	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Basophils/Leukocytes >1.2 × ULN	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities Eosinophils >1.2 × ULN	2 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities Eosinophils/Leukocytes >1.2 × ULN	3 Participants	4 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities Monocytes >1.2 × ULN	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Monocytes/Leukocytes >1.2 × ULN	0 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities Potassium >1.1 × ULN	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities Bicarbonate <0.9 × LLN	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Glucose >1.5 × ULN	2 Participants	3 Participants	4 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities Fibrinogen >1.25 × ULN	3 Participants	11 Participants	4 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities URINE Glucose >=1	2 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Ketones >=1	0 Participants	2 Participants	1 Participants	3 Participants
Number of Participants With Laboratory Test Abnormalities URINE Protein >=1	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities URINE Hemoglobin >=1	4 Participants	4 Participants	2 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities URINE Bilirubin >=1	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Nitrite >=1	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Leukocyte Esterase >=1	3 Participants	9 Participants	5 Participants	3 Participants
Number of Participants With Laboratory Test Abnormalities URINE Leukocytes (/HPF) >=20	0 Participants	1 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1, Weeks 1, 2, 4, 6, ET and FUP (28-35 days post-last dose)

Population: Analysis population included all participants who received at least 1 dose of study treatment.

The investigator or designee assessed tolerability at the site of investigational product application (pre-dose and immediately post-dose). This assessment focused on the treated non-lesional skin using the scale: none = no evidence of local intolerance; mild = minimal erythema and/or oedema, slight glazed appearance; moderate = definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology; severe (to be reported as an AE) = erythema, oedema glazing with fissures, few vesicles or papules: consider removing topical agent (if still in place); very severe (to be reported as an AE) = strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent (if still in place).

Outcome measures

Outcome measures
Measure	AD Vehicle Once Daily (QD) n=34 Participants Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=36 Participants Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD n=17 Participants Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD n=17 Participants Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 4 Very Severe	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 6 None	24 Participants	33 Participants	11 Participants	14 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 6 Mild	3 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 6 Moderate	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 6 Severe	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 6 Very Severe	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP ET None	3 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Day 1 Mild	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Day 1 Severe	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 1 None	25 Participants	33 Participants	17 Participants	16 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 1 Severe	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 2 None	26 Participants	34 Participants	15 Participants	16 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 2 Mild	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 2 Moderate	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 2 Severe	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 4 Mild	4 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 4 Moderate	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP ET Severe	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 4 Severe	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP ET Mild	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP ET Moderate	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP ET Very Severe	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP FUP None	25 Participants	29 Participants	12 Participants	15 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP FUP Mild	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP FUP Moderate	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP FUP Severe	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP FUP Very Severe	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Day 1 None	33 Participants	35 Participants	17 Participants	17 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Day 1 Moderate	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Day 1 Very Severe	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 1 Mild	4 Participants	3 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 1 Moderate	2 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 1 Very Severe	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 2 Very Severe	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP Week 4 None	22 Participants	32 Participants	13 Participants	16 Participants

Adverse Events

AD Vehicle Once Daily (QD)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

AD PF-07038124 0.01% QD

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Psoriasis Vehicle QD

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Psoriasis PF-07038124 0.01% QD

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

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

Other adverse events
Measure	AD Vehicle Once Daily (QD) n=34 participants at risk Participants in AD group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	AD PF-07038124 0.01% QD n=36 participants at risk Participants in AD group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis Vehicle QD n=17 participants at risk Participants in plaque psoriasis group received vehicle ointment in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.	Psoriasis PF-07038124 0.01% QD n=17 participants at risk Participants in plaque psoriasis group received PF-07038124 ointment at 0.01% in 60 g tube with QD dosing beginning on Day 1 through the final dose at Week 6 visit.
General disorders Application site pruritus	5.9% 2/34 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/36 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Dermatitis atopic	8.8% 3/34 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	2.8% 1/36 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Pruritus	2.9% 1/34 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/36 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 1/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/34 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/36 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	11.8% 2/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Herpes zoster	0.00% 0/34 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/36 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 1/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Urinary tract infection	0.00% 0/34 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/36 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 1/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/34 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/36 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 1/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Blood glucose increased	0.00% 0/34 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/36 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 1/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations SARS-CoV-2 test positive	2.9% 1/34 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/36 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 1/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/34 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/36 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 1/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/34 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/36 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 1/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/34 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/36 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 1/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/34 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/36 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 1/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Psychiatric disorders Suicidal ideation	0.00% 0/34 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/36 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 1/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/34 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/36 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 1/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Vascular disorders Hypertension	0.00% 0/34 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/36 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 1/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/17 • Day 1 through Week 6 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.