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

Completed · Phase 2

Conditions studied: Atopic Dermatitis, Plaque Psoriasis

In brief

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 facts

Study ID

NCT05375955

Run by

Pfizer

People needed

263

Starts

2022-09-26

Expected to finish

2023-07-31

Last updated by the study team

2024-10-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Renaissance Research and Medical Group — Cape Coral, Florida, United States
• Clinical Neuroscience Solutions, Inc. dba CNS Healthcare — Jacksonville, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• Skin Care Physicians of Georgia — Macon, Georgia, United States
• Sneeze, Wheeze & Itch Associates, LLC — Normal, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Velocity Clinical Research at The Dermatology Clinic, Baton Rouge — Baton Rouge, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Wayne Health — Dearborn, Michigan, United States
• Northwell Health Clinical Trials Office — Lake Success, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Vital Prospects Clinical Research Institute, PC — Tulsa, Oklahoma, United States
• Velocity Clinical Research, Medford — Medford, Oregon, United States
• Health Concepts — Rapid City, South Dakota, United States
• Clinical Neuroscience Solutions Inc. — Memphis, Tennessee, United States
• Clinical Neuroscience Solutions, Inc. dba CNS Healthcare — Memphis, Tennessee, United States
• Dermatology Treatment and Research Center — Dallas, Texas, United States
• Progressive Clinical Research — San Antonio, Texas, United States
• Texas Dermatology and Laser Specialists — San Antonio, Texas, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States
• Dermatology Research Institute — Calgary, Alberta, Canada
• Wiseman Dermatology Research Inc. — Winnipeg, Manitoba, Canada

Full record on ClinicalTrials.gov

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