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NCT05995964Active, not recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
507 (actual)
First submitted
26 Jul 2023
Start date
22 Aug 2023
Primary completion date
12 Nov 2026
Lead sponsor
Pfizer
NCT number
NCT05995964
EU CT number
2023-505218-68-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 507
  • From 22 Aug 2023 to the primary completion date, 12 Nov 2026
  • 94 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any of the following acute or chronic infections or infection history:
    • Active infection (including helminth or parasitic) requiring treatment within 2 weeks prior to screening;
    • Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1;
    • 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.
    • Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1;
  • Current use of any prohibited concomitant medication(s).
  • 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:
  • 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).

Other illness

  • \- Medical Conditions:
  • 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.
  • 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.
  • 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.
  • HIV infection, or infection with hepatitis B or hepatitis C viruses according to protocol-specific testing algorithm.
  • 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.

Lab values

  • 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:

Who the study is looking for

  • Must meet the following AD criteria:
  • Participants aged 18 years or older
  • Clinical diagnosis of chronic atopic dermatitis:
    • for at least 6 months prior to Day 1 with diagnosis confirmed by photograph;
    • 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;
    • Moderate to severe AD defined as having an affected BSA ≥10%, vIGA ≥3, and EASI ≥16 at both the screening and baseline visits).
    • 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:
  • BMI of 17.5 to 40 kg/m2; and a total body weight \>45 kg (100 lbs).
  • Willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (94)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Box Hill Hospital
Coordinator of this site? Confirm its status
Box HillAustraliaUnknown status
Sinclair Dermatology
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East MelbourneAustraliaUnknown status
Fremantle Dermatology
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FremantleAustraliaUnknown status
Australian Clinical Research Network
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SydneyAustraliaUnknown status
INTERMED Groupe Sante
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ChicoutimiCanadaUnknown status
Medicor Research Inc
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Greater SudburyCanadaUnknown status
Sudbury Skin Clinique
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Greater SudburyCanadaUnknown status
Lima's Excellence in Allergy and Dermatology Research
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HamiltonCanadaUnknown status
DermEdge Research
Coordinator of this site? Confirm its status
MississaugaCanadaUnknown status
Centre de Recherche Saint-Louis inc.
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QuébecCanadaUnknown status
Toronto Research Centre
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TorontoCanadaUnknown status
Wiseman Dermatology Research Inc.
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WinnipegCanadaUnknown status
Beijing Friendship Hospital Affiliate of Capital University
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
The Second Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
Chengdu Second People's Hospital
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ChengduChinaUnknown status
Dongguan People's Hospital
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DongguanChinaUnknown status
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaUnknown status
Guangdong Province Dermatology Hospital
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GuangzhouChinaUnknown status
Hangzhou Third Hospital
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HangzhouChinaUnknown status
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
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HangzhouChinaUnknown status
First Affiliated Hospital of Kunming Medical University
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KunmingChinaUnknown status
Dermatology Hospital of Jiangxi Province
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NanchangChinaUnknown status
Shanghai First People's Hospital
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ShanghaiChinaUnknown status
Huashan Hospital, Fudan University
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ShanghaiChinaUnknown status
The First Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
The First Hospital of Wuhan
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WuhanChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaUnknown status
Thermalsole und Schwefelbad Bentheim GmbH
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Bad BentheimGermanyActive, not recruiting
Magdeburger Company For Medical Studies & Services GmbH
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MagdeburgGermanyActive, not recruiting
BAG Dres. med. Quist PartG
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MainzGermanyActive, not recruiting
Nihonbashi Sakura Clinic
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Chuo-kuJapanUnknown status
Fukuwa Clinic
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Chuo-kuJapanUnknown status
Osaka Metropolitan University Hospital
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OsakaJapanUnknown status
Medical Corporation Heishinkai OPHAC Hospital
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OsakaJapanUnknown status
Naoko Dermatology Clinic
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Setagaya-kuJapanUnknown status
Nomura Dermatology Clinic
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YokohamaJapanUnknown status
Synexus Polska Sp. z o.o.
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KatowicePolandActive, not recruiting
Provita Sp z o o
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KatowicePolandActive, not recruiting
Zdybski Med Sp. z o. o.
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Ostrowiec ŚwiętokrzyskiPolandActive, not recruiting
NIEPUBLICZNY ZAKLAD OPIEKI ZDROWOTNEJ ZESPOL PORADNI SPECJALISTYCZNYCH "TERMEDICA"
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PoznanPolandActive, not recruiting
Synexus Polska Sp. z o.o.
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WroclawPolandActive, not recruiting
AllerVie Clinical Research
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BirminghamUnited StatesUnknown status
Renaissance Research and Medical Group
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Cape CoralUnited StatesUnknown status
Epic Medical Research - Oklahoma
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ChickashaUnited StatesUnknown status
Michigan Center for Research Company
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ClarkstonUnited StatesUnknown status
Florida International Medical Research
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Coral GablesUnited StatesUnknown status
Dermatology Treatment and Research Center
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DallasUnited StatesUnknown status
Revival Research
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DoralUnited StatesUnknown status
St. Jude Clinical Research
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DoralUnited StatesUnknown status
Empire Dermatology
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East SyracuseUnited StatesUnknown status
North Texas Center for Clinical Research
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FriscoUnited StatesUnknown status
AboutSkin Research, LLC
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Greenwood VillageUnited StatesUnknown status
Alpesh D. Desai, DO PLLC
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HoustonUnited StatesUnknown status
Marvel Clinical Research
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Huntington BeachUnited StatesUnknown status
Maryland Laser Skin and Vein
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Hunt ValleyUnited StatesUnknown status
Dawes Fretzin Clinical Research Group, LLC
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IndianapolisUnited StatesUnknown status
Clinical Partners LLC
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JohnstonUnited StatesUnknown status
California Allergy and Asthma Medical Group
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Los AngelesUnited StatesUnknown status
Apex Clinical Research Center
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Mayfield HeightsUnited StatesUnknown status
Velocity Clinical Research, Medford
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MedfordUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc.
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MemphisUnited StatesUnknown status
SouthCoast Research Center
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MiamiUnited StatesUnknown status
Floridian Research Institute Llc
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MiamiUnited StatesUnknown status
Global Health Research Center, Inc.
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Miami LakesUnited StatesUnknown status
Southern Indiana Clinical trials
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New AlbanyUnited StatesUnknown status
University Dermatology Trials, INC.
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Newport BeachUnited StatesUnknown status
Private Practice - Dr. Bobby Buka
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New YorkUnited StatesUnknown status
Sadick Research Group
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New YorkUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesUnknown status
Virginia Dermatology and Skin Cancer Center
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NorfolkUnited StatesUnknown status
Ziaderm Research LLC
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North Miami BeachUnited StatesUnknown status
Northridge Clinical Trials
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NorthridgeUnited StatesUnknown status
MI Skin Innovations
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NorthvilleUnited StatesUnknown status
Profound Research LLC
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OceansideUnited StatesUnknown status
Unity Clinical Research
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Oklahoma CityUnited StatesUnknown status
Skin Specialists, PC dba Schlessinger MD
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OmahaUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc.
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OrlandoUnited StatesUnknown status
Onyx Clinical Research - Peoria
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PeoriaUnited StatesUnknown status
Paddington Testing Co Inc
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PhiladelphiaUnited StatesUnknown status
Onyx Clinical Research
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PhoenixUnited StatesUnknown status
DCT-Stone Oak, LLC dba Discovery Clinical Trials
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San AntonioUnited StatesUnknown status
West Dermatology La Jolla
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San DiegoUnited StatesUnknown status
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
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San DiegoUnited StatesUnknown status
Spartanburg Medical Research
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SpartanburgUnited StatesUnknown status
GCP Research, Global Clinical professionals
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St. PetersburgUnited StatesUnknown status
Complete Dermatology
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Sugar LandUnited StatesUnknown status
ForCare Clinical Research
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TampaUnited StatesUnknown status
Revival Research Institute, LLC
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TroyUnited StatesUnknown status
Banner - University Medicine Dermatology Clinic
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TucsonUnited StatesUnknown status
Vital Prospects Clinical Research Institute., PC
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TulsaUnited StatesUnknown status
Sunwise Clinical Research
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Walnut CreekUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.