Psoriasis Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

264

Study ID:

NCT05375955

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 37 Locations for this study

See Locations Near You

California Dermatology & Clinical Research Institute
Encinitas California, 92024, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Renaissance Research and Medical Group
Cape Coral Florida, 33991, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville Florida, 32256, United States
ForCare Clinical Research
Tampa Florida, 33613, United States
Skin Care Physicians of Georgia
Macon Georgia, 31217, United States
Sneeze, Wheeze & Itch Associates, LLC
Normal Illinois, 61761, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis Indiana, 46250, United States
Velocity Clinical Research at The Dermatology Clinic, Baton Rouge
Baton Rouge Louisiana, 70808, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Wayne Health
Dearborn Michigan, 48124, United States
Northwell Health Clinical Trials Office
Lake Success New York, 11042, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10028, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Vital Prospects Clinical Research Institute, PC
Tulsa Oklahoma, 74136, United States
Velocity Clinical Research, Medford
Medford Oregon, 97504, United States
Health Concepts
Rapid City South Dakota, 57702, United States
Clinical Neuroscience Solutions Inc.
Memphis Tennessee, 38119, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Memphis Tennessee, 38119, United States
Dermatology Treatment and Research Center
Dallas Texas, 75230, United States
Progressive Clinical Research
San Antonio Texas, 78213, United States
Texas Dermatology and Laser Specialists
San Antonio Texas, 78218, United States
Virginia Clinical Research, Inc.
Norfolk Virginia, 23502, United States
Dermatology Research Institute
Calgary Alberta, T2J 7, Canada
Wiseman Dermatology Research Inc.
Winnipeg Manitoba, R3M 3, Canada
Lynderm Research Inc.
Markham Ontario, L3P 1, Canada
DermEdge Research
Mississauga Ontario, L4Y 4, Canada
DermEdge Research
Mississauga Ontario, L5H 1, Canada
SKiN Centre for Dermatology
Peterborough Ontario, K9J 5, Canada
Innovaderm Research Inc.
Montréal Quebec, H2X 2, Canada
Centre de Recherche Dermatologique du Quebec metropolitain
Quebec , G1V 4, Canada
Takagi Dermatological Clinic Branch
Obihiro Hokkaido, 080-0, Japan
Takagi Dermatology
Obihiro Hokkaido, 080-0, Japan
Dermatology Shimizu Clinic
Kobe Hyogo, 657-0, Japan
Dermatology and Ophthalmology Kume Clinic
Sakai City Osaka, 593-8, Japan
Shirasaki dermatology clinic
Takaoka Toyama, 933-0, Japan
Egin Research High Wycombe
High Wycombe Buckinghamshire, HP11 , United Kingdom
Southampton General Hospital
Southampton Hampshire, SO16 , United Kingdom
Accellacare - North London
Northwood London, CITY OF, HA6 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

264

Study ID:

NCT05375955

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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