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

Atopic Dermatitis Clinical Trial

Official title:

A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MULTIPLE DOSE LEVELS OF PF-07038124 OINTMENT FOR 12 WEEKS IN PARTICIPANTS 12 YEARS AND OLDER AND WITH MILD-TO-MODERATE ATOPIC DERMATITIS OR MILD-TO-SEVERE PLAQUE PSORIASIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05375955
• Other study ID #: C3941005
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Plaque Psoriasis
• Psoriasis

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

External Links

•   To obtain contact information for a study center near you, click here.