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RECRUITING

NCT05995964

PHASE2

A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this study is to learn about the safety and effects of 2 study medicines (PF-07275315 and PF-07264660) for the treatment of atopic dermatitis (AD). AD is a long- lasting itchy red rash, caused by a skin reaction. This study is seeking participants who: * are 18 years of age or more. * Were confirmed to have AD at least 6 months ago. * Are not having an effective treatment result from medicines that are applied on skin for AD. * Are considered by their doctors to have moderate to severe AD. In Stage 1 of the study, participants will receive either PF-07275315 or PF-07264660 or placebo. Stage 1 is complete. In Stage 2 of the study participants will receive either PF-07275315 or placebo. In Stage 3 of the study participants who have received anti-inflammatory proteins, will receive either PF-07275315 or placebo. In Stage 4 of the study participants will receive either PF-07264660 or placebo. A placebo does not have any medicine in it but looks just like the medicines being studied. PF-07275315 or PF-07264660 or placebo will be given as multiple shots in the clinic over the course of each Stage. The experiences of people receiving PF-07275315 or PF-07264660 will be compared to people who do not. This will help determine if PF-07275315 and PF-07264660 are safe and effective. Participants in Stages 1, 2 and 4 will be involved in this study for up to 40 weeks (10 months). Participants in Stage 3 will be involved in this study for up to 52 weeks (13 months).

Official title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-07275315 AND PF-07264660 IN ADULT PARTICIPANTS WITH MODERATE-SEVERE ATOPIC DERMATITIS

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

340

Start Date

2023-08-22

Completion Date

2027-03-08

Last Updated

2026-02-13

Healthy Volunteers

Conditions

Atopic Dermatitis

Interventions

DRUG

PF-07275315

subcutaneous injection

DRUG

PF-07264660

subcutaneous injection

OTHER

Placebo

subcutaneous injection

Inclusion Criteria: Must meet the following AD criteria: 1. Participants aged 18 years or older 2. Clinical diagnosis of chronic atopic dermatitis: 1. for at least 6 months prior to Day 1 with diagnosis confirmed by photograph; 2. Either an inadequate response to treatment with standard of care treatments (excluding systemic immunosuppressant treatments) for at least 4 consecutive weeks within 6 to 12 months of the first dose of the study intervention; OR documented reason why topical treatments are considered medically inappropriate; 3. Moderate to severe AD defined as having an affected BSA ≥10%, vIGA ≥3, and EASI ≥16 at both the screening and baseline visits). 4. Bio-experienced cohort-partial or non-responder to anti-inflammatory proteins (also known as biologics), intolerance or AEs to anti-inflammatory proteins or loss of access to anti-inflammatory proteins with ≥12 weeks of treatment within 5 years. Other Inclusion Criteria: 3. BMI of 17.5 to 40 kg/m2; and a total body weight \>45 kg (100 lbs). 4. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures. Exclusion Criteria: \- Medical Conditions: 1. Significant allergic or autoimmune diseases, other than AD and well controlled mild to moderate including but not limited to: SLE or other complement disorders; Type 1 diabetes; IBD; Multiple Sclerosis. 2. History of significant allergic reactions, including anaphylaxis and reactions to protein therapeutics, including hypersensitivity to PF-07275315 or PF-07264660 or to the excipients of the formulated drug products. Participants with significant reactions to single, identified, avoidable allergens (eg, peanut allergy) may be eligible if avoidance of these allergens during the study is feasible. 3. Any of the following acute or chronic infections or infection history: 1. Active infection (including helminth or parasitic) requiring treatment within 2 weeks prior to screening; 2. Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1; 3. Active chronic or acute skin infection requiring treatment with systemic \[(not IV)\] antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to Day 1, or superficial skin infections (requiring no more than topical anti-infective treatments) within 1 week prior to Day 1. 4. Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1; 4. History of or current evidence of inflammatory skin conditions (eg, psoriasis, seborrheic dermatitis, lupus) at the time of Day 1 that could interfere with evaluation of AD or response to treatment. 5. Any 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. \- Prior/Concomitant Therapy: 6. Current use of any prohibited concomitant medication(s). 7. Phototherapy narrowband UVB (NB UVB) or broadband phototherapy or regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks prior to Day 1. \- Prior/Concurrent Clinical Study Experience: 8. Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). 9. HIV infection, or infection with hepatitis B or hepatitis C viruses according to protocol-specific testing algorithm. 10. Evidence of active or latent TB, or inadequately treated infection with Mycobacterium TB. A participant who is currently being treated for active or latent TB infection must be excluded from this study.

Locations (97)

Allervie Clinical Research

Birmingham, Alabama, United States

Onyx Clinical Research - Peoria

Peoria, Arizona, United States

Medical Dermatology Specialists

Phoenix, Arizona, United States

Onyx Clinical Research

Phoenix, Arizona, United States

Banner - University Medicine Dermatology Clinic

Tucson, Arizona, United States

Marvel Clinical Research

Huntington Beach, California, United States

California Allergy and Asthma Medical Group

Los Angeles, California, United States

University Dermatology Trials, INC.

Newport Beach, California, United States

Northridge Clinical Trials

Northridge, California, United States

Profound Research LLC

Oceanside, California, United States

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

San Diego, California, United States

West Dermatology La Jolla

San Diego, California, United States

Sunwise Clinical Research

Walnut Creek, California, United States

AboutSkin Research, LLC

Greenwood Village, Colorado, United States

Renaissance Research and Medical Group

Cape Coral, Florida, United States

Florida International Medical Research

Coral Gables, Florida, United States

Revival Research

Doral, Florida, United States

St. Jude Clinical Research

Doral, Florida, United States

SouthCoast Research Center

Miami, Florida, United States

Floridian Research Institute Llc

Miami, Florida, United States

Global Health Research Center, Inc.

Miami Lakes, Florida, United States

Ziaderm Research LLC

North Miami Beach, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

GCP Research, Global Clinical professionals

St. Petersburg, Florida, United States

ForCare Clinical Research

Tampa, Florida, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Southern Indiana Clinical Trials

New Albany, Indiana, United States

Maryland Laser Skin and Vein

Hunt Valley, Maryland, United States

Michigan Center for Research Company

Clarkston, Michigan, United States

MI Skin Innovations

Northville, Michigan, United States

Revival Research Institute LLC

Troy, Michigan, United States

Skin Specialists, PC dba Schlessinger MD

Omaha, Nebraska, United States

Empire Dermatology

East Syracuse, New York, United States

Private Practice - Dr. Bobby Buka

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Sadick Research Group

New York, New York, United States

Apex Clinical Research Center

Mayfield Heights, Ohio, United States

Epic Medical Research - Oklahoma

Chickasha, Oklahoma, United States

Unity Clinical Research

Oklahoma City, Oklahoma, United States

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, United States

Velocity Clinical Research, Medford

Medford, Oregon, United States

Paddington Testing Co, Inc

Philadelphia, Pennsylvania, United States

Clinical Partners, LLC

Johnston, Rhode Island, United States

National Allergy and Asthma

North Charleston, South Carolina, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Clinical Neuroscience Solutions Inc.

Memphis, Tennessee, United States

Dermatology Treatment and Research Center

Dallas, Texas, United States

North Texas Center for Clinical Research

Frisco, Texas, United States

Alpesh D. Desai, DO PLLC

Houston, Texas, United States

DCT-Stone Oak, LLC dba Discovery Clinical Trials

San Antonio, Texas, United States

Complete Dermatology

Sugar Land, Texas, United States

Virginia Dermatology and Skin Cancer Center

Norfolk, Virginia, United States

Australian Clinical Research Network

Sydney, New South Wales, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Dr Rodney Sinclair Pty Ltd

East Melbourne, Victoria, Australia

Fremantle Dermatology

Fremantle, Western Australia, Australia

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

Medicor Research Inc

Greater Sudbury, Ontario, Canada

Sudbury Skin Clinique

Greater Sudbury, Ontario, Canada

Lima's Excellence in Allergy and Dermatology Research

Hamilton, Ontario, Canada

DermEdge Research

Mississauga, Ontario, Canada

Toronto Research Centre

Toronto, Ontario, Canada

INTERMED Groupe Sante

Chicoutimi, Quebec, Canada

Centre de Recherche Saint-Louis inc.

Québec, Canada

Beijing Friendship Hospital Affiliate of Capital University

Beijing, Beijing Municipality, China

The First Affiliated Hospital Of Fujian Medical University

Fuzhou, Fujian, China

Dongguan People's Hospital

Dongguan, Guangdong, China

Guangdong Province Dermatology Hospital

Guangzhou, Guangdong, China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The Second Xiangya Hospital of Central South University

Changsha, Hu'nan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, China

The first hospital of jilin university

Changchun, Jilin, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Chengdu second people's hospital

Chengdu, Sichuan, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Hangzhou Third Hospital

Hangzhou, Zhejiang, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Shanghai First People's Hospital

Shanghai, China

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, Germany

BAG Drs. Med. Quist PartG

Mainz, Rhineland-Palatinate, Germany

Magdeburger Company for Medical Studies and Services

Magdeburg, Saxony-Anhalt, Germany

Nomura Dermatology Clinic

Yokohama, Kanagawa, Japan

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Osaka, Japan

Osaka Metropolitan University Hospital

Osaka, Osaka, Japan

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo, Japan

Fukuwa Clinic

Chuo-ku, Tokyo, Japan

Naoko Dermatology Clinic

Setagaya-ku, Tokyo, Japan

Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica"

Poznan, Greater Poland Voivodeship, Poland

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship, Poland

Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

Wroclaw, Lower Silesian Voivodeship, Poland

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, Poland

Synexus Polska Sp. z o.o. Oddzial w Katowicach

Katowice, Poland

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland

Clinical Research Directory

A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (97)