Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis

NCT04664153 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: C39410022020-003977-23
• Study Type: interventional
• Target: 104
• Locations: 4 countries
• Sites: 29

Brief Summary

This study is being conducted to provide data on efficacy, safety, tolerability and PK of PF-07038124 ointment versus vehicle control in the treatment of mild to moderate AD and mild to moderate plaque psoriasis.

Conditions

Atopic Dermatitis; Plaque Psoriasis

Keywords

atopic dermatitis, plaque psoriasis

Outcome Measures

Primary Outcomes (2)

• Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 for AD Participants

  EASI evaluated severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

  Baseline, Week 6

• Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 6 for Plaque Psoriasis Participants

  Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease, where higher scores = greater severity of psoriasis.

  Baseline, Week 6

Secondary Outcomes (17)

• Percentage of AD 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 6

  Baseline, Week 6

• Percentage of AD Participants Achieving EASI 75 (75% Improvement From Baseline) at Weeks 1, 2, 4, 6 and Follow-up (FUP)/End of Study (EOS)

  Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

• Percentage of AD Participants Having >=4 Points of Reduction in Weekly Averages of Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 4 and 6

  Baseline, Weeks 1, 2, 4 and 6

• Change From Baseline in EASI Total Score at Weeks 1, 2, 4, 6 and FUP/EOS for AD Participants

  Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

• Percentage of AD Participants Achieving IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS

  Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

Study Arms (4)

atopic dermatitis - PF-07038124 ointment

EXPERIMENTAL

Drug: PF-07038124 ointment

atopic dermatitis - vehicle ointment

PLACEBO COMPARATOR

Drug: Vehicle ointment

plaque psoriasis - PF-07038124 ointment

EXPERIMENTAL

Drug: PF-07038124 ointment

plaque psoriasis - vehicle ointment

EXPERIMENTAL

Drug: Vehicle ointment

Interventions

PF-07038124 ointment DRUG

PF-07038124 ointment at 0.01% with QD dosing for 6 weeks

atopic dermatitis - PF-07038124 ointment; plaque psoriasis - PF-07038124 ointment

Vehicle ointment DRUG

Vehicle ointment with QD dosing for 6 weeks

atopic dermatitis - vehicle ointment; plaque psoriasis - vehicle ointment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Atopic Dermatitis (AD): Have been diagnosed with AD for at least 3 months; Have an Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate); Have AD covering 5% to 20% (inclusive) of BSA.
• Plaque psoriasis: Have been diagnosed with plaque psoriasis (psoriasis vulgaris) for at least 6 months; Have a Physician Global Assessment (PGA) score of 2 (mild), or 3 (moderate); Having plaque psoriasis covering 5% to 15% (inclusive) of BSA.

You may not qualify if:

• Presence of skin comorbidities that would interfere with study assessment or response to treatment.
• Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (29)

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Renaissance Research and Medical Group

Cape Coral, Florida, 33991, United States

Location

Olympian Clinical Research

Clearwater, Florida, 33756, United States

Location

Moonshine Research Center, Inc.

Doral, Florida, 33166, United States

Location

Clinical Neuroscience Solutions

Orlando, Florida, 32801, United States

Location

Center for Clinical Studies

Tampa, Florida, 33613, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

Location

Henry Ford Medical Center, New Center One

Detroit, Michigan, 48202, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

studies in Dermatology, LLC

Cypress, Texas, 77433, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

Center for Clinical Studies, LTD. LLP

Webster, Texas, 77598, United States

Location

Australian Clinical Research Network

Maroubra, New South Wales, 2035, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

Dermatrials Research Inc.

Hamilton, Ontario, L8N 1Y2, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

Location

DermEdge Research

Mississauga, Ontario, L5H 1G9, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

Centre de Recherche Dermatologique du Quebec metropolitain

Québec, G1V 4X7, Canada

Location

NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL

Bialystok, 15-453, Poland

Location

Mazowieckie Centrum Badań Klinicznych

Grodzisk Mazowiecki, 05-825, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, 40-611, Poland

Location

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, 90-242, Poland

Location

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Kliniczny Szpital Wojewódzki nr 1 im. F. Chopina w Rzeszowie

Rzeszów, 35-055, Poland

Location

ETG Warszawa

Warsaw, 02-793, Poland

Location

Related Publications (1)

• Eichenfield LF, Tarabar S, Forman S, Garcia-Bello A, Feng G, Fetterly G, Mahling P, Peeva E, Vincent MS, Chandra DE. Efficacy and Safety of PF-07038124 in Patients With Atopic Dermatitis and Plaque Psoriasis: A Randomized Clinical Trial. JAMA Dermatol. 2024 Feb 1;160(2):156-163. doi: 10.1001/jamadermatol.2023.4990.

  PMID: 38117526 DERIVED

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic

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_Inquiries@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: December 6, 2020
• First Posted: December 11, 2020
• Study Start: December 21, 2020
• Primary Completion: August 18, 2021
• Study Completion: August 18, 2021
• Last Updated: August 26, 2022
• Results First Posted: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

US (15); AU (2); PL (7); CA (5)