A Study To Learn About The Safety, Efficacy and Tolerability of PF-07038124 Ointment In Participants With Mild-To-Moderate Atopic Dermatitis Or Mild-To-Severe Plaque Psoriasis

• Status: Not yet recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical trial is to learn about how the safety, how well the study medicine works, extent to which side affects 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

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