Back to Trials
NCT05995964PHASE2Recruiting

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

Pfizer

Start Date

8/22/2023

Completion Date

3/8/2027

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

PF-07275315

DRUG

PF-07264660

OTHER

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Atopic Dermatitis

Locations

Allervie Clinical Research

Birmingham, Alabama 35209

United States

Onyx Clinical Research - Peoria

Peoria, Arizona 85381

United States

Medical Dermatology Specialists

Phoenix, Arizona 85006

United States

Onyx Clinical Research

Phoenix, Arizona 85050

United States

Banner - University Medicine Dermatology Clinic

Tucson, Arizona 85718

United States

Marvel Clinical Research

Huntington Beach, California 92647

United States

California Allergy and Asthma Medical Group

Los Angeles, California 90025

United States

University Dermatology Trials, INC.

Newport Beach, California 92660

United States

Northridge Clinical Trials

Northridge, California 91325

United States

Profound Research LLC

Oceanside, California 92056

United States

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

San Diego, California 92121

United States

West Dermatology La Jolla

San Diego, California 92121

United States

Sunwise Clinical Research

Walnut Creek, California 94596

United States

AboutSkin Research, LLC

Greenwood Village, Colorado 80111

United States

Renaissance Research and Medical Group

Cape Coral, Florida 33991

United States

Florida International Medical Research

Coral Gables, Florida 33134

United States

Revival Research

Doral, Florida 33122

United States

St. Jude Clinical Research

Doral, Florida 33172

United States

SouthCoast Research Center

Miami, Florida 33136

United States

Floridian Research Institute Llc

Miami, Florida 33179

United States

Global Health Research Center, Inc.

Miami Lakes, Florida 33016

United States

Ziaderm Research LLC

North Miami Beach, Florida 33162

United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida 32801

United States

GCP Research, Global Clinical professionals

St. Petersburg, Florida 33705

United States

ForCare Clinical Research

Tampa, Florida 33613

United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana 46250

United States

Southern Indiana Clinical Trials

New Albany, Indiana 47150

United States

Maryland Laser Skin and Vein

Hunt Valley, Maryland 21030

United States

Michigan Center for Research Company

Clarkston, Michigan 48346

United States

MI Skin Innovations

Northville, Michigan 48167

United States

Revival Research Institute LLC

Troy, Michigan 48084

United States

Skin Specialists, PC dba Schlessinger MD

Omaha, Nebraska 68144

United States

Empire Dermatology

East Syracuse, New York 13057

United States

Private Practice - Dr. Bobby Buka

New York, New York 10012

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Sadick Research Group

New York, New York 10075

United States

Apex Clinical Research Center

Mayfield Heights, Ohio 44124

United States

Epic Medical Research - Oklahoma

Chickasha, Oklahoma 73018

United States

Unity Clinical Research

Oklahoma City, Oklahoma 73118

United States

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma 74136

United States

Velocity Clinical Research, Medford

Medford, Oregon 97504

United States

Paddington Testing Co, Inc

Philadelphia, Pennsylvania 19103

United States

Clinical Partners, LLC

Johnston, Rhode Island 02919

United States

National Allergy and Asthma

North Charleston, South Carolina 29420

United States

Spartanburg Medical Research

Spartanburg, South Carolina 29303

United States

Clinical Neuroscience Solutions Inc.

Memphis, Tennessee 38119

United States

Dermatology Treatment and Research Center

Dallas, Texas 75230

United States

North Texas Center for Clinical Research

Frisco, Texas 75034

United States

Alpesh D. Desai, DO PLLC

Houston, Texas 77008

United States

DCT-Stone Oak, LLC dba Discovery Clinical Trials

San Antonio, Texas 78258

United States

Complete Dermatology

Sugar Land, Texas 77479

United States

Virginia Dermatology and Skin Cancer Center

Norfolk, Virginia 23502

United States

Australian Clinical Research Network

Sydney, New South Wales NSW 2035

Australia

Box Hill Hospital

Box Hill, Victoria 3128

Australia

Sinclair Dermatology

East Melbourne, Victoria 3002

Australia

Fremantle Dermatology

Fremantle, Western Australia 6160

Australia

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba R3M 3Z4

Canada

Medicor Research Inc

Greater Sudbury, Ontario P3C 1X3

Canada

Sudbury Skin Clinique

Greater Sudbury, Ontario P3C 1X8

Canada

Lima's Excellence in Allergy and Dermatology Research

Hamilton, Ontario L8L 3C3

Canada

DermEdge Research

Mississauga, Ontario L4Y 4C5

Canada

Toronto Research Centre

Toronto, Ontario M3H 5Y8

Canada

INTERMED Groupe Sante

Chicoutimi, Quebec G7H 7Y8

Canada

Centre de Recherche Saint-Louis inc.

Québec, G1W 4R4

Canada

Beijing Friendship Hospital Affiliate of Capital University

Beijing, Beijing Municipality 100050

China

The First Affiliated Hospital Of Fujian Medical University

Fuzhou, Fujian 350005

China

Dongguan People's Hospital

Dongguan, Guangdong 523109

China

Guangdong Province Dermatology Hospital

Guangzhou, Guangdong 510091

China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei 050031

China

The Second Xiangya Hospital of Central South University

Changsha, Hu'nan 410011

China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei 430000

China

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu 212001

China

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi 330000

China

The first hospital of jilin university

Changchun, Jilin 130021

China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi 710061

China

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality 200040

China

Chengdu second people's hospital

Chengdu, Sichuan 610017

China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality 300052

China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan 650032

China

Hangzhou Third Hospital

Hangzhou, Zhejiang 310009

China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang 310014

China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang 310016

China

Shanghai First People's Hospital

Shanghai, 201620

China

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony 48455

Germany

BAG Drs. Med. Quist PartG

Mainz, Rhineland-Palatinate 55128

Germany

Magdeburger Company for Medical Studies and Services

Magdeburg, Saxony-Anhalt 39104

Germany

Nomura Dermatology Clinic

Yokohama, Kanagawa 221-0825

Japan

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Osaka 532-0003

Japan

Osaka Metropolitan University Hospital

Osaka, Osaka 545-8586

Japan

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo 103-0025

Japan

Fukuwa Clinic

Chuo-ku, Tokyo 104-0031

Japan

Naoko Dermatology Clinic

Setagaya-ku, Tokyo 158-0097

Japan

Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica"

Poznan, Greater Poland Voivodeship 60-681

Poland

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship 30-727

Poland

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

Wroclaw, Lower Silesian Voivodeship 50-381

Poland

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship 40-611

Poland

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

Katowice, 40-040

Poland

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship 27-400

Poland