A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
NCT ID: NCT05375955
Last Updated: 2024-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
263 participants
INTERVENTIONAL
2022-09-26
2023-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Atopic Dermatitis PF-07038124 0.01% ointment
Atopic Dermatitis
PF-07038124 ointment 0.01%
Atopic Dermatitis and Plaque Psoriasis
Atopic Dermatitis Vehicle ointment
Atopic Dermatitis
Vehicle ointment
Atopic Dermatitis and Plaque Psoriasis
Atopic Dermatitis PF-07038124 0.03% ointment
Atopic Dermatitis
PF-07038124 ointment 0.03%
Atopic Dermatitis and Plaque Psoriasis
Plaque Psoriasis PF-07038124 0.01% ointment
Plaque Psoriasis
PF-07038124 ointment 0.01%
Atopic Dermatitis and Plaque Psoriasis
Plaque Psoriasis PF-07038124 0.03% ointment
Plaque Psoriasis
PF-07038124 ointment 0.03%
Atopic Dermatitis and Plaque Psoriasis
Plaque Psoriasis PF-07038124 0.06% ointment
Plaque Psoriasis
PF-07038124 ointment 0.06%
PF-07038124 ointment 0.06% (Plaque Psoriasis only)
Plaque Psoriasis Vehicle ointment
Plaque Psoriasis
Vehicle ointment
Atopic Dermatitis and Plaque Psoriasis
Interventions
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PF-07038124 ointment 0.01%
Atopic Dermatitis and Plaque Psoriasis
Vehicle ointment
Atopic Dermatitis and Plaque Psoriasis
PF-07038124 ointment 0.03%
Atopic Dermatitis and Plaque Psoriasis
PF-07038124 ointment 0.06%
PF-07038124 ointment 0.06% (Plaque Psoriasis only)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
12 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Lynderm Research Inc.
Markham, Ontario, Canada
DermEdge Research
Mississauga, Ontario, Canada
DermEdge Research
Mississauga, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Centre de Recherche Dermatologique du Quebec metropolitain
Québec, , Canada
Takagi Dermatological Clinic Branch
Obihiro, Hokkaido, Japan
Takagi Dermatology
Obihiro, Hokkaido, Japan
Dermatology Shimizu Clinic
Kobe, Hyōgo, Japan
Dermatology and Ophthalmology Kume Clinic
Sakai, Osaka, Japan
Shirasaki dermatology clinic
Takaoka, Toyama, Japan
Egin Research High Wycombe
High Wycombe, Buckinghamshire, United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom
Accellacare - North London
Northwood, London, CITY of, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C3941005
Identifier Type: -
Identifier Source: org_study_id
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