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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05375955
Other study ID # C3941005
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 26, 2022
Est. completion date July 31, 2023

Study information

Verified date February 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 264
Est. completion date July 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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 Design


Intervention

Drug:
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)

Locations

Country Name City State
Canada Dermatology Research Institute Calgary Alberta
Canada Lynderm Research Inc. Markham Ontario
Canada DermEdge Research Mississauga Ontario
Canada DermEdge Research Mississauga Ontario
Canada Innovaderm Research Inc. Montréal Quebec
Canada SKiN Centre for Dermatology Peterborough Ontario
Canada Centre de Recherche Dermatologique du Quebec metropolitain Quebec
Canada Wiseman Dermatology Research Inc. Winnipeg Manitoba
Japan Dermatology Shimizu Clinic Kobe Hyogo
Japan Takagi Dermatological Clinic Branch Obihiro Hokkaido
Japan Takagi Dermatology Obihiro Hokkaido
Japan Dermatology and Ophthalmology Kume Clinic Sakai City Osaka
Japan Shirasaki dermatology clinic Takaoka Toyama
United Kingdom Egin Research High Wycombe High Wycombe Buckinghamshire
United Kingdom Accellacare - North London Northwood London, CITY OF
United Kingdom Southampton General Hospital Southampton Hampshire
United States University of Michigan Ann Arbor Michigan
United States Velocity Clinical Research at The Dermatology Clinic, Baton Rouge Baton Rouge Louisiana
United States Renaissance Research and Medical Group Cape Coral Florida
United States Dermatology Treatment and Research Center Dallas Texas
United States Wayne Health Dearborn Michigan
United States California Dermatology & Clinical Research Institute Encinitas California
United States Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana
United States Clinical Neuroscience Solutions, Inc. dba CNS Healthcare Jacksonville Florida
United States Northwell Health Clinical Trials Office Lake Success New York
United States USC/Norris Comprehensive Cancer Center Los Angeles California
United States Skin Care Physicians of Georgia Macon Georgia
United States Velocity Clinical Research, Medford Medford Oregon
United States Clinical Neuroscience Solutions Inc. Memphis Tennessee
United States Clinical Neuroscience Solutions, Inc. dba CNS Healthcare Memphis Tennessee
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 Virginia Clinical Research, Inc. Norfolk Virginia
United States Sneeze, Wheeze & Itch Associates, LLC Normal Illinois
United States Health Concepts Rapid City South Dakota
United States Progressive Clinical Research San Antonio Texas
United States Texas Dermatology and Laser Specialists San Antonio Texas
United States ForCare Clinical Research Tampa Florida
United States Vital Prospects Clinical Research Institute, PC Tulsa Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Japan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants achieving Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of =2 points at Week 12 Atopic Dermatitis population only Week 12
Primary Proportion of participants achieving Patient Global Assessment (PGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of =2 points at Week 12 Plaque Psoriasis population only Week 12
Secondary Proportion of participants achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline Atopic Dermatitis population only Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Secondary Proportion of participants achieving >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline Plaque Psoriasis population only Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Secondary Proportion of participants achieving IGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of =2 points Atopic Dermatitis population only Week 1, 2, 4, 6, 8, 10, and Follow-up
Secondary Proportion of participants achieving PGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of =2 points Plaque Psoriasis population only Week 1, 2, 4, 6, 8, 10, and Follow-up
Secondary Proportion of Participants Achieving IGA Score of Clear (0) or Almost Clear (1) Atopic Dermatitis population only Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Secondary Proportion of Participants Achieving PGA Score of Clear (0) or Almost Clear (1) Plaque Psoriasis population only Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Secondary Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) total score Atopic Dermatitis population only Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Secondary Change From Baseline in Psoriasis Area and Severity Index (PASI) total score Plaque Psoriasis population only Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Secondary Proportion of participants having =4 points of reduction from baseline in weekly averages of PP-NRS Atopic Dermatitis population only Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Secondary Proportion of adult (18-75 years old) participants having =4 points of reduction from baseline in weekly averages of Peak Pruritus Numerical Rating Scale (PP-NRS) Plaque Psoriasis population only Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Secondary Percent CFB in Affected Body Surface Area (BSA) Atopic Dermatitis and Plaque Psoriasis population Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Secondary Incidence of Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Atopic Dermatitis and Plaque Psoriasis population Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Secondary Number of Participants With Clinically Significant Changes in Vital Signs Atopic Dermatitis and Plaque Psoriasis population Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Secondary Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Atopic Dermatitis and Plaque Psoriasis population Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Secondary Number of Participants With Clinically Significant Changes in Laboratory Abnormalities Atopic Dermatitis and Plaque Psoriasis population Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Secondary Incidence of Increase in Local Tolerability Severity Grades Atopic Dermatitis and Plaque Psoriasis population Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
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