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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis; Plaque Psoriasis

Treatments: Drug: PF-07038124 ointment 0.03%; Drug: PF-07038124 ointment 0.01%; Drug: PF-07038124 ointment 0.06%; Drug: Vehicle ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT05375955

C3941005

Details and patient eligibility

About

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.

Enrollment: 263 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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263 participants in 7 patient groups, including a placebo group

Atopic Dermatitis PF-07038124 0.01% ointment

Experimental group

Description:

Atopic Dermatitis

Treatment:

Drug: PF-07038124 ointment 0.01%

Atopic Dermatitis Vehicle ointment

Placebo Comparator group

Description:

Atopic Dermatitis

Treatment:

Drug: Vehicle ointment

Atopic Dermatitis PF-07038124 0.03% ointment

Experimental group

Description:

Atopic Dermatitis

Treatment:

Drug: PF-07038124 ointment 0.03%

Plaque Psoriasis PF-07038124 0.01% ointment

Experimental group

Description:

Plaque Psoriasis

Treatment:

Drug: PF-07038124 ointment 0.01%

Plaque Psoriasis PF-07038124 0.03% ointment

Experimental group

Description:

Plaque Psoriasis

Treatment:

Drug: PF-07038124 ointment 0.03%

Plaque Psoriasis PF-07038124 0.06% ointment

Experimental group

Description:

Plaque Psoriasis

Treatment:

Drug: PF-07038124 ointment 0.06%

Plaque Psoriasis Vehicle ointment

Placebo Comparator group

Description:

Plaque Psoriasis

Treatment:

Drug: Vehicle ointment