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

Last updated: November 21, 2024
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

2

Condition

Skin Infections/disorders

Skin Wounds

Eczema (Atopic Dermatitis - Pediatric)

Treatment

PF-07264660

PF-07275315

Placebo

Clinical Study ID

NCT05995964
C4531002
  • 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.

All participants in the study will receive either PF-07275315 or 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 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.

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 will be involved in this study for up to 40 weeks (20 months). During this time, Stage 1 participants will have 16 visits at the study clinic, and Stage 2 participants will have 12 visits at the study clinic.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Must meet the following AD criteria:

  1. Clinical diagnosis of chronic atopic dermatitis for at least 6 months prior to Day 1;

  2. Either an inadequate response to treatment with standard of care treatments (excluding systemic immunosuppressant treatments) for at least 4 consecutive weekswithin 6 to 12 months of the first dose of the study intervention; OR documentedreason why topical treatments are considered medically inappropriate;

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

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

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:
September 17, 2026

Connect with a study center

  • Box Hill Hospital

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • 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 P3E 5M4
    Canada

    Site Not Available

  • Toronto Research Centre

    Toronto, Ontario M3H 5Y8
    Canada

    Site Not Available

  • INTERMED Groupe Sante

    Chicoutimi, Quebec G7H 7Y8
    Canada

    Active - Recruiting

  • Centre de Recherche Saint-Louis

    Quebec, G1W 4R4
    Canada

    Active - Recruiting

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Site Not Available

  • Guangdong Province Dermatology Hospital

    Guangzhou, Guangdong 510018
    China

    Site Not Available

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai 200040
    China

    Site Not Available

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

    Hangzhou, Zhejiang 310016
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 310014
    China

    Site Not Available

  • Nomura Dermatology Clinic

    Yokohama-city, Kanagawa 221-0825
    Japan

    Site Not Available

  • Medical Corporation Heishinkai OPHAC Hospital

    Osaka-shi, Osaka 532-0003
    Japan

    Site Not Available

  • Fukuwa Clinic

    Chuo-ku, Tokyo 104-0031
    Japan

    Site Not Available

  • Nihonbashi Sakura Clinic

    Chuo-ku, Tokyo 103-0025
    Japan

    Site Not Available

  • Allervie Clinical Research

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Medical Dermatology Specialists

    Phoenix, Arizona 85006
    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

    Active - Recruiting

  • California Allergy and Asthma Medical Group

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • Northridge Clinical Trials

    Northridge, California 91325
    United States

    Active - Recruiting

  • Profound Research LLC

    Oceanside, California 92056
    United States

    Site Not Available

  • 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

    Active - Recruiting

  • 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

  • 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

  • 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

    Site Not Available

  • 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

    Active - Recruiting

  • Paddington Testing Company

    Philadelphia, Pennsylvania 19103
    United States

    Active - Recruiting

  • Clinical Partners, LLC

    Johnston, Rhode Island 02919
    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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