A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.

Study Overview
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Brief Summary
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The purpose of this clinical trial is to learn about the safety, how well the study medicine works, extent to which side effects can be tolerated, and how the study medicine is changed and eliminated from your body after you apply it on your skin. The study medicine is in ointment form. This study is seeking participants who If they have Atopic Dermatitis (AD): Have a diagnosis for at least 3 months Have a diagnosis of mild or moderate disease assessed using Investigator's Global Assessment (IGA) Have percent Body Surface Area (%BSA) covering 5% up to 40% A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2 during the screening period If they have plaque psoriasis (PsO): Have a diagnosis for at least 6 months Have a diagnosis of mild, moderate, or severe disease assessed using Physician's Global Assessment (PGA) Have percent Body Surface Area (%BSA) covering 2% up to 20% All participants in this study will receive either 0.01% PF-07038124, 0.03% PF-07038124, or a vehicle ointment. In addition, some participants with PsO will receive 0.06% PF- PF-07038124. Participants will not know which dose level they have received. The participants will be randomly assigned to each dose group. PF-07038124 ointment will be applied topically to affected areas once daily. We will compare the experiences of people receiving the different dose levels of the ointment to those who receive the vehicle ointment. This will help us determine if PF-07038124 ointment is safe and effective. Participants will take part in this study for approximately 21 weeks. Participants will apply the study medicine once daily for 12 weeks followed by a safety follow-up period of 4-5 weeks from last application of study medicine to last visit.

Official Title
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A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MULTIPLE DOSE LEVELS OF PF-07038124 OINTMENT FOR 12 WEEKS IN PARTICIPANTS 12 YEARS AND OLDER AND WITH MILD-TO-MODERATE ATOPIC DERMATITIS OR MILD-TO-SEVERE PLAQUE PSORIASIS

Conditions
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Plaque Psoriasis, Atopic Dermatitis

Intervention / Treatment
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* Drug: PF-07038124 ointment 0.01%
* Drug: Vehicle ointment
* Drug: PF-07038124 ointment 0.03%
* Drug: PF-07038124 ointment 0.06%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for AD population: Diagnosis of Atopic Dermatitis (AD) for at least 3 months Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate) AD covering 5% and up to 40% of Body Surface Area (BSA) A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2 Inclusion Criteria for Plaque Psoriasis Diagnosis of Plaque Psoriasis (PsO) for at least 6 months Physician Global Assessment (PGA) score of 2 (mild), 3 (moderate), or 4 (severe) PsO covering 2% to 20% (inclusive) of BSA Exclusion Criteria: Presence of skin comorbidities that would interfere with study assessment or response to treatment Psychiatric condition including recent or active suicidal ideation or behavior Current or recent history of severe, progressive, or uncontrolled disease A history of systemic, chronic or acute skin infection requiring hospitalization, parenteral antimicrobial therapy, or is judged clinically significant. Recent, significant trauma or major surgery History of cancer or have undergone treatment for any type of cancer, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ with no evidence of recurrence. History of angioedema or anaphylaxis to topical products or known sensitivity to any of the components of the investigational products. Use of any prohibited concomitant medication(s) Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participants with an estimated glomerular filtration rate (eGFR) of <40 mL/min/1.73m2 calculated using the serum creatinine-based Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula for adults and serum creatinine >1.5 x upper limit of normal (ULN) in adolescents (12-18 years old) Participants with total bilirubin ≥2x ULN (≥3 x ULN for Gilbert's disease), aspartate aminotransferase (AST) ≥2.5 x ULN, ALT ≥2.5 x ULN. Clinically relevant abnormal baseline standard 12-lead electrocardiogram (ECG) including, but not limited to QTC corrected using Fridericia's Formula (QTcF) interval >450 msec and QRS > 120 msec A recent history of alcohol or substance abuse

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atopic Dermatitis PF-07038124 0.01% ointment<br>Atopic Dermatitis | Drug: PF-07038124 ointment 0.01%<br>* Atopic Dermatitis and Plaque Psoriasis<br>|
| Placebo Comparator: Atopic Dermatitis Vehicle ointment<br>Atopic Dermatitis | Drug: Vehicle ointment<br>* Atopic Dermatitis and Plaque Psoriasis<br>|
| Experimental: Atopic Dermatitis PF-07038124 0.03% ointment<br>Atopic Dermatitis | Drug: PF-07038124 ointment 0.03%<br>* Atopic Dermatitis and Plaque Psoriasis<br>|
| Experimental: Plaque Psoriasis PF-07038124 0.01% ointment<br>Plaque Psoriasis | Drug: PF-07038124 ointment 0.01%<br>* Atopic Dermatitis and Plaque Psoriasis<br>|
| Experimental: Plaque Psoriasis PF-07038124 0.03% ointment<br>Plaque Psoriasis | Drug: PF-07038124 ointment 0.03%<br>* Atopic Dermatitis and Plaque Psoriasis<br>|
| Experimental: Plaque Psoriasis PF-07038124 0.06% ointment<br>Plaque Psoriasis | Drug: PF-07038124 ointment 0.06%<br>* PF-07038124 ointment 0.06% (Plaque Psoriasis only)<br>|
| Placebo Comparator: Plaque Psoriasis Vehicle ointment<br>Plaque Psoriasis | Drug: Vehicle ointment<br>* Atopic Dermatitis and Plaque Psoriasis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of 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 12 | Atopic Dermatitis population only | Week 12 | 
| Proportion of participants achieving Patient Global Assessment (PGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at Week 12 | Plaque Psoriasis population only | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline | Atopic Dermatitis population only | Week 1, 2, 4, 6, 8, 10, 12, and Follow-up | 
| Proportion of participants achieving >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline | Plaque Psoriasis population only | Week 1, 2, 4, 6, 8, 10, 12, and Follow-up | 
| Proportion of participants achieving IGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points | Atopic Dermatitis population only | Week 1, 2, 4, 6, 8, 10, and Follow-up | 
| Proportion of participants achieving PGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points | Plaque Psoriasis population only | Week 1, 2, 4, 6, 8, 10, and Follow-up | 
| Proportion of Participants Achieving IGA Score of Clear (0) or Almost Clear (1) | Atopic Dermatitis population only | Week 1, 2, 4, 6, 8, 10, 12, and Follow-up | 
| Proportion of Participants Achieving PGA Score of Clear (0) or Almost Clear (1) | Plaque Psoriasis population only | Week 1, 2, 4, 6, 8, 10, 12, and Follow-up | 
| Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) total score | Atopic Dermatitis population only | Week 1, 2, 4, 6, 8, 10, 12, and Follow-up | 
| Change From Baseline in Psoriasis Area and Severity Index (PASI) total score | Plaque Psoriasis population only | Week 1, 2, 4, 6, 8, 10, 12, and Follow-up | 
| Proportion of participants having ≥4 points of reduction from baseline in weekly averages of PP-NRS | Atopic Dermatitis population only | Week 1, 2, 4, 6, 8, 10, 12, and Follow-up | 
| Proportion of adult (18-75 years old) participants having ≥4 points of reduction from baseline in weekly averages of Peak Pruritus Numerical Rating Scale (PP-NRS) | Plaque Psoriasis population only | Week 1, 2, 4, 6, 8, 10, 12, and Follow-up | 
| Percent CFB in Affected Body Surface Area (BSA) | Atopic Dermatitis and Plaque Psoriasis population | Week 1, 2, 4, 6, 8, 10, 12, and Follow-up | 
| Incidence of Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Atopic Dermatitis and Plaque Psoriasis population | Week 1, 2, 4, 6, 8, 10, 12, and Follow-up | 
| Number of Participants With Clinically Significant Changes in Vital Signs | Atopic Dermatitis and Plaque Psoriasis population | Week 1, 2, 4, 6, 8, 10, 12, and Follow-up | 
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | Atopic Dermatitis and Plaque Psoriasis population | Week 1, 2, 4, 6, 8, 10, 12, and Follow-up | 
| Number of Participants With Clinically Significant Changes in Laboratory Abnormalities | Atopic Dermatitis and Plaque Psoriasis population | Week 1, 2, 4, 6, 8, 10, 12, and Follow-up | 
| Incidence of Increase in Local Tolerability Severity Grades | Atopic Dermatitis and Plaque Psoriasis population | Week 1, 2, 4, 6, 8, 10, 12, and Follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eczema, topical