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

Conditions

• Atopic Dermatitis
• Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PF-07038124 ointment 0.01% — DRUG
  Atopic Dermatitis and Plaque Psoriasis
• Vehicle ointment — DRUG
  Atopic Dermatitis and Plaque Psoriasis
• PF-07038124 ointment 0.03% — DRUG
  Atopic Dermatitis and Plaque Psoriasis
• PF-07038124 ointment 0.06% — DRUG
  PF-07038124 ointment 0.06% (Plaque Psoriasis only)

Study Details

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.

Key Dates

First listed

May 17, 2022

Start date

Sep 26, 2022

Status verified

Sep 2024

Primary completion

Jul 31, 2023

Completion

Jul 31, 2023

Study Design

Enrollment

263 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Atopic Dermatitis PF-07038124 0.01% ointment
  Atopic Dermatitis
• Placebo Comparator: Atopic Dermatitis Vehicle ointment
  Atopic Dermatitis
• Experimental: Atopic Dermatitis PF-07038124 0.03% ointment
  Atopic Dermatitis
• Experimental: Plaque Psoriasis PF-07038124 0.01% ointment
  Plaque Psoriasis
• Experimental: Plaque Psoriasis PF-07038124 0.03% ointment
  Plaque Psoriasis
• Experimental: Plaque Psoriasis PF-07038124 0.06% ointment
  Plaque Psoriasis
• Placebo Comparator: Plaque Psoriasis Vehicle ointment
  Plaque Psoriasis

Primary Outcome Measure

Percentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) Only [ Time Frame: Baseline, Week 12 ]

Locations (23)

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