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

NCT05375955 | Completed Phase 2 Results FDA Drug

• 1 other identifier: C3941005
• Study Type: interventional
• Target: 263
• Locations: 4 countries
• Sites: 39

Brief 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.

Conditions

Atopic Dermatitis; Plaque Psoriasis

Keywords

Eczema; topical

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) Only

  IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting.95 percentage (%)confidence interval was based on Blyth-Still-Casella method.

  Baseline, Week 12

• Percentage of Participants With Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Week 12: Participants With Plaque Psoriasis Only

  The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). In this OM, percentages of participants with a PGA score of 0 or 1 and an improvement of \>=2 from Baseline in PGA score were reported. 95% confidence interval (CI) was based on Blyth-Still-Casella method.

  Baseline, Week 12

Secondary Outcomes (17)

• Percentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis Only

  Baseline, Week 1, 2, 4, 6, 8, 10 and 12

• Percentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis Only

  Baseline, Week 1, 2, 4, 6, 8, 10 and 12

• Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis Only

  Baseline, Week 1, 2, 4, 6, 8, and 10

• Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis Only

  Baseline, Week 1, 2, 4, 6, 8, and 10

• Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only

  Week 1, 2, 4, 6, 8, 10 and 12

Study Arms (7)

Atopic Dermatitis PF-07038124 0.01% ointment

EXPERIMENTAL

Atopic Dermatitis

Drug: PF-07038124 ointment 0.01%

Atopic Dermatitis Vehicle ointment

PLACEBO COMPARATOR

Atopic Dermatitis

Drug: Vehicle ointment

Atopic Dermatitis PF-07038124 0.03% ointment

EXPERIMENTAL

Atopic Dermatitis

Drug: PF-07038124 ointment 0.03%

Plaque Psoriasis PF-07038124 0.01% ointment

EXPERIMENTAL

Plaque Psoriasis

Drug: PF-07038124 ointment 0.01%

Plaque Psoriasis PF-07038124 0.03% ointment

EXPERIMENTAL

Plaque Psoriasis

Drug: PF-07038124 ointment 0.03%

Plaque Psoriasis PF-07038124 0.06% ointment

EXPERIMENTAL

Plaque Psoriasis

Drug: PF-07038124 ointment 0.06%

Plaque Psoriasis Vehicle ointment

PLACEBO COMPARATOR

Plaque Psoriasis

Drug: Vehicle ointment

Interventions

PF-07038124 ointment 0.01% DRUG

Atopic Dermatitis and Plaque Psoriasis

Atopic Dermatitis PF-07038124 0.01% ointment; Plaque Psoriasis PF-07038124 0.01% ointment

Vehicle ointment DRUG

Atopic Dermatitis and Plaque Psoriasis

Atopic Dermatitis Vehicle ointment; Plaque Psoriasis Vehicle ointment

PF-07038124 ointment 0.03% DRUG

Atopic Dermatitis and Plaque Psoriasis

Atopic Dermatitis PF-07038124 0.03% ointment; Plaque Psoriasis PF-07038124 0.03% ointment

PF-07038124 ointment 0.06% DRUG

PF-07038124 ointment 0.06% (Plaque Psoriasis only)

Plaque Psoriasis PF-07038124 0.06% ointment

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (39)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Renaissance Research and Medical Group

Cape Coral, Florida, 33991, United States

Location

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, 32256, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Skin Care Physicians of Georgia

Macon, Georgia, 31217, United States

Location

Sneeze, Wheeze & Itch Associates, LLC

Normal, Illinois, 61761, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Velocity Clinical Research at The Dermatology Clinic, Baton Rouge

Baton Rouge, Louisiana, 70808, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Wayne Health

Dearborn, Michigan, 48124, United States

Location

Northwell Health Clinical Trials Office

Lake Success, New York, 11042, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10028, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, 74136, United States

Location

Velocity Clinical Research, Medford

Medford, Oregon, 97504, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Clinical Neuroscience Solutions Inc.

Memphis, Tennessee, 38119, United States

Location

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

Dermatology Research Institute

Calgary, Alberta, T2J 7E1, Canada

Location

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

Location

DermEdge Research

Mississauga, Ontario, L4Y 4C5, Canada

Location

DermEdge Research

Mississauga, Ontario, L5H 1G9, Canada

Location

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

Centre de Recherche Dermatologique du Quebec metropolitain

Québec, G1V 4X7, Canada

Location

Takagi Dermatological Clinic Branch

Obihiro, Hokkaido, 080-0013, Japan

Location

Takagi Dermatology

Obihiro, Hokkaido, 080-0013, Japan

Location

Dermatology Shimizu Clinic

Kobe, Hyōgo, 657-0846, Japan

Location

Dermatology and Ophthalmology Kume Clinic

Sakai, Osaka, 593-8324, Japan

Location

Shirasaki dermatology clinic

Takaoka, Toyama, 933-0871, Japan

Location

Egin Research High Wycombe

High Wycombe, Buckinghamshire, HP11 2QW, United Kingdom

Location

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Accellacare - North London

Northwood, London, CITY of, HA6 2RN, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquires@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: September 26, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: October 2, 2024
• Results First Posted: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (23); GB (3); JP (5); CA (8)