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

Last updated: June 23, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

2

Condition

Dermatitis, Atopic

Allergy

Allergies & Asthma

Treatment

PF-07264660

PF-07275315

Placebo

Clinical Study ID

NCT05995964
C4531002
2023-505218-68-00
  • Ages > 18
  • All Genders

Study 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. 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 12 weeks.

Stage 1 participants will receive shots at the study clinic on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.

Stage 2 participants will receive shots at the study clinic on Day 1, Week 4, Week 8 and Week 12.

Stage 3 participants will receive shots at the study clinic on Day 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 28.

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 Stage 1 and 2 will be involved in this study for up to 40 weeks (10 months). During this time, Stage 1 participants will have 13 visits at the study clinic, and Stage 2 participants will have 9 visits at the study clinic. Participants in Stage 3 will be involved in this study for up to 52 weeks (13 months); and will have 13 visits at the study clinic.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Must meet the following AD criteria:

  1. Participants aged 18 years or older

  2. Clinical diagnosis of chronic atopic dermatitis:

  3. for at least 6 months prior to Day 1 with diagnosis confirmed by photograph;

  4. Either an inadequate response to treatment with standard of care treatments (excluding systemic immunosuppressant treatments) for at least 4 consecutiveweeks within 6 to 12 months of the first dose of the study intervention; ORdocumented reason why topical treatments are considered medicallyinappropriate;

  5. Moderate to severe AD defined as having an affected BSA ≥10%, vIGA ≥3, and EASI ≥16 at both the screening and baseline visits).

  6. Bio-experienced cohort-partial or non-responder to anti-inflammatory proteins,intolerance or AEs to anti-inflammatory proteins or loss of access toanti-inflammatory proteins. Other Inclusion Criteria:

  7. BMI of 17.5 to 40 kg/m2; and a total body weight >45 kg (100 lbs).

  8. Willing and able to comply with all scheduled visits, treatment plan, laboratorytests and other study procedures.

Exclusion

Exclusion Criteria:

  • Medical Conditions:
  1. Significant allergic or autoimmune diseases, other than AD and well controlled mildto moderate including but not limited to: SLE or other complement disorders; Type 1diabetes; IBD; Multiple Sclerosis.

  2. History of significant allergic reactions, including anaphylaxis and reactions toprotein therapeutics, including hypersensitivity to PF-07275315 or PF-07264660 or tothe excipients of the formulated drug products. Participants with significantreactions to single, identified, avoidable allergens (eg, peanut allergy) may beeligible if avoidance of these allergens during the study is feasible.

  3. Any of the following acute or chronic infections or infection history:

  4. Active infection (including helminth or parasitic) requiring treatment within 2weeks prior to screening;

  5. Infection requiring hospitalization or systemic (parenteral) antimicrobialtherapy within 60 days prior to Day 1;

  6. Active chronic or acute skin infection requiring treatment with systemic [(notIV)] antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungalswithin 2 weeks prior to Day 1, or superficial skin infections (requiring nomore than topical anti-infective treatments) within 1 week prior to Day 1.

  7. Any infection judged to be an opportunistic infection or clinically significantby the investigator, within 6 months prior to Day 1;

  8. History of or current evidence of inflammatory skin conditions (eg, psoriasis,seborrheic dermatitis, lupus) at the time of Day 1 that could interfere withevaluation of AD or response to treatment.

  9. Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may increase therisk of study participation or, in the investigator's judgment, make the participantinappropriate for the study.

  • Prior/Concomitant Therapy:
  1. Current use of any prohibited concomitant medication(s).

  2. Phototherapy narrowband UVB (NB UVB) or broadband phototherapy or regular use (morethan 2 visits per week) of a tanning booth/parlor within 4 weeks prior to Day 1.

  • Prior/Concurrent Clinical Study Experience:
  1. Previous administration with an investigational product (drug or vaccine) within 30days (or as determined by the local requirement) or 5 half lives preceding the firstdose of study intervention used in this study (whichever is longer).

  2. HIV infection, or infection with hepatitis B or hepatitis C viruses according toprotocol-specific testing algorithm.

  3. Evidence of active or latent TB, or inadequately treated infection withMycobacterium TB. A participant who is currently being treated for active or latentTB infection must be excluded from this study.

Study Design

Total Participants: 340
Treatment Group(s): 3
Primary Treatment: PF-07264660
Phase: 2
Study Start date:
August 22, 2023
Estimated Completion Date:
November 14, 2026

Connect with a study center

  • Momentum Darlinghurst

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Australian Clinical Research Network

    Sydney, New South Wales NSW 2035
    Australia

    Site Not Available

  • Box Hill Hospital

    Box Hill, Victoria 3128
    Australia

    Active - Recruiting

  • Dr Rodney Sinclair Pty Ltd

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Fremantle Dermatology

    Fremantle, Western Australia 6160
    Australia

    Active - Recruiting

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Active - Recruiting

  • Lima's Excellence in Allergy and Dermatology Research

    Hamilton, Ontario L8L 3C3
    Canada

    Active - Recruiting

  • DermEdge Research

    Mississauga, Ontario L4Y 4C5
    Canada

    Active - Recruiting

  • Medicor Research Inc

    Sudbury, Ontario P3C 1X3
    Canada

    Active - Recruiting

  • Sudbury Skin Clinique

    Sudbury, Ontario P3C 1X8
    Canada

    Active - Recruiting

  • Toronto Research Centre

    Toronto, Ontario M3H 5Y8
    Canada

    Active - Recruiting

  • INTERMED Groupe Sante

    Chicoutimi, Quebec G7H 7Y8
    Canada

    Active - Recruiting

  • Centre de Recherche Saint-Louis

    Quebec, G1W 4R4
    Canada

    Active - Recruiting

  • Beijing Friendship Hospital Affiliate of Capital University

    Beijing, Beijing 100050
    China

    Active - Recruiting

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Active - Recruiting

  • Guangdong Province Dermatology Hospital

    Guangzhou, Guangdong 510091
    China

    Active - Recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050031
    China

    Active - Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430000
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • Dermatology Hospital of Jiangxi Province

    Nanchang, Jiangxi 330000
    China

    Active - Recruiting

  • The first hospital of jilin university

    Changchun City, Jilin 130021
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Active - Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Active - Recruiting

  • Hangzhou Third Hospital

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310016
    China

    Active - Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 310014
    China

    Site Not Available

  • Chengdu second people's hospital

    Chengdu,
    China

    Site Not Available

  • Shanghai First People's Hospital

    Shanghai, 201620
    China

    Site Not Available

  • Fachklinik Bad Bentheim

    Bad Bentheim, Niedersachsen 48455
    Germany

    Site Not Available

  • Magdeburger Company for Medical Studies and Services

    Magdeburg, Sachsen-anhalt 39104
    Germany

    Site Not Available

  • Nomura Dermatology Clinic

    Yokohama-city, Kanagawa 221-0825
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital

    Osaka-City, Osaka 545-8586
    Japan

    Active - Recruiting

  • Medical Corporation Heishinkai OPHAC Hospital

    Osaka-shi, Osaka 532-0003
    Japan

    Active - Recruiting

  • Fukuwa Clinic

    Chuo-ku, Tokyo 104-0031
    Japan

    Active - Recruiting

  • Nihonbashi Sakura Clinic

    Chuo-ku, Tokyo 103-0025
    Japan

    Active - Recruiting

  • Naoko Dermatology Clinic

    Setagaya-ku, Tokyo 158-0097
    Japan

    Active - Recruiting

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

    Wroclaw, Dolnośląskie 50-381
    Poland

    Site Not Available

  • Pratia MCM Krakow

    Kraków, Małopolskie 30-727
    Poland

    Site Not Available

  • Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica"

    Poznan, Wielkopolskie 60-681
    Poland

    Site Not Available

  • Centrum Medyczne Angelius Provita

    Katowice, Śląskie 40-611
    Poland

    Site Not Available

  • Dermedic Jacek Zdybski

    Ostrowiec Swietokrzyski, Świętokrzyskie 27-400
    Poland

    Site Not Available

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

    Katowice, 40-040
    Poland

    Site Not Available

  • Allervie Clinical Research

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Onyx Clinical Research - Peoria

    Peoria, Arizona 85381
    United States

    Active - Recruiting

  • Medical Dermatology Specialists

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Onyx Clinical Research

    Phoenix, Arizona 85050
    United States

    Active - Recruiting

  • Banner - University Medicine Dermatology Clinic

    Tucson, Arizona 85718
    United States

    Active - Recruiting

  • Marvel Clinical Research

    Huntington Beach, California 92647
    United States

    Active - Recruiting

  • Sunwise Clinical Research

    Lafayette, California 94549
    United States

    Site Not Available

  • California Allergy and Asthma Medical Group

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • University Dermatology Trials, INC.

    Newport Beach, California 92660
    United States

    Active - Recruiting

  • Northridge Clinical Trials

    Northridge, California 91325
    United States

    Active - Recruiting

  • Profound Research LLC

    Oceanside, California 92056
    United States

    Active - Recruiting

  • Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

    San Diego, California 92121
    United States

    Active - Recruiting

  • West Dermatology La Jolla

    San Diego, California 92121
    United States

    Active - Recruiting

  • Wr-McCr, Llc

    San Diego, California 92120
    United States

    Site Not Available

  • Sunwise Clinical Research

    Walnut Creek, California 94596
    United States

    Active - Recruiting

  • AboutSkin Research, LLC

    Greenwood Village, Colorado 80111
    United States

    Terminated

  • Renaissance Research and Medical Group

    Cape Coral, Florida 33991
    United States

    Active - Recruiting

  • Florida Academic Centers Research and Education, LLC

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Florida International Medical Research

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Revival Research

    Doral, Florida 33122
    United States

    Active - Recruiting

  • St. Jude Clinical Research

    Doral, Florida 33172
    United States

    Active - Recruiting

  • Solutions Through Advanced Research

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Floridian Research Institute

    Miami, Florida 33179
    United States

    Active - Recruiting

  • Floridian Research Institute Llc

    Miami, Florida 33179
    United States

    Active - Recruiting

  • SouthCoast Research Center

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Global Health Research Center, Inc.

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Tory Sullivan, Md Pa

    North Miami Beach, Florida 33162
    United States

    Active - Recruiting

  • Ziaderm Research LLC

    North Miami Beach, Florida 33162
    United States

    Active - Recruiting

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida 32801
    United States

    Active - Recruiting

  • GCP Research, Global Clinical professionals

    Saint Petersburg, Florida 33705
    United States

    Active - Recruiting

  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Southern Indiana Clinical Trials

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • Maryland Laser Skin and Vein

    Hunt Valley, Maryland 21030
    United States

    Active - Recruiting

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
    United States

    Site Not Available

  • Michigan Center for Research Company

    Clarkston, Michigan 48346
    United States

    Active - Recruiting

  • MI Skin Innovations

    Northville, Michigan 48167
    United States

    Active - Recruiting

  • Revival Research Institute LLC

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • Revival Research Institute, LLC

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • Skin Specialists, PC

    Omaha, Nebraska 68144
    United States

    Active - Recruiting

  • Empire Dermatology

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Private Practice - Dr. Bobby Buka

    New York, New York 10012
    United States

    Active - Recruiting

  • Sadick Research Group

    New York, New York 10075
    United States

    Active - Recruiting

  • Apex Clinical Research Center

    Mayfield Heights, Ohio 44124
    United States

    Active - Recruiting

  • Epic Medical Research - Oklahoma

    Chickasha, Oklahoma 73018
    United States

    Active - Recruiting

  • Epic Medical Research-Oklahoma

    Chickasha, Oklahoma 73018
    United States

    Active - Recruiting

  • Unity Clinical Research

    Oklahoma City, Oklahoma 73118
    United States

    Active - Recruiting

  • Vital Prospects Clinical Research Institute, PC

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Velocity Clinical Research, Medford

    Medford, Oregon 97504
    United States

    Site Not Available

  • Paddington Testing Co, Inc

    Philadelphia, Pennsylvania 19103
    United States

    Active - Recruiting

  • Paddington Testing Company

    Philadelphia, Pennsylvania 19103
    United States

    Site Not Available

  • Clinical Partners, LLC

    Johnston, Rhode Island 02919
    United States

    Active - Recruiting

  • National Allergy and Asthma

    North Charleston, South Carolina 29420
    United States

    Active - Recruiting

  • Spartanburg Medical Research

    Spartanburg, South Carolina 29303
    United States

    Active - Recruiting

  • Clinical Neuroscience Solutions Inc.

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

  • Dermatology Treatment and Research Center

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • North Texas Center for Clinical Research

    Frisco, Texas 75034
    United States

    Active - Recruiting

  • Alpesh D. Desai, DO PLLC

    Houston, Texas 77008
    United States

    Active - Recruiting

  • DCT-Stone Oak, LLC dba Discovery Clinical Trials

    San Antonio, Texas 78258
    United States

    Active - Recruiting

  • Complete Dermatology

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

  • Virginia Dermatology and Skin Cancer Center

    Norfolk, Virginia 23502
    United States

    Terminated

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