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
- Diseases
- Atopic dermatitis (eczema)
- 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
Sites (94)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Box Hill Hospital Coordinator of this site? Confirm its status | Box Hill | Australia | Unknown status |
| Sinclair Dermatology Coordinator of this site? Confirm its status | East Melbourne | Australia | Unknown status |
| Fremantle Dermatology Coordinator of this site? Confirm its status | Fremantle | Australia | Unknown status |
| Australian Clinical Research Network Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| INTERMED Groupe Sante Coordinator of this site? Confirm its status | Chicoutimi | Canada | Unknown status |
| Medicor Research Inc Coordinator of this site? Confirm its status | Greater Sudbury | Canada | Unknown status |
| Sudbury Skin Clinique Coordinator of this site? Confirm its status | Greater Sudbury | Canada | Unknown status |
| Lima's Excellence in Allergy and Dermatology Research Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| DermEdge Research Coordinator of this site? Confirm its status | Mississauga | Canada | Unknown status |
| Centre de Recherche Saint-Louis inc. Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Toronto Research Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Wiseman Dermatology Research Inc. Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Beijing Friendship Hospital Affiliate of Capital University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Chengdu Second People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Dongguan People's Hospital Coordinator of this site? Confirm its status | Dongguan | China | Unknown status |
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Guangdong Province Dermatology Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Hangzhou Third Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| First Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Dermatology Hospital of Jiangxi Province Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Shanghai First People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Hospital of Wuhan Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Thermalsole und Schwefelbad Bentheim GmbH Coordinator of this site? Confirm its status | Bad Bentheim | Germany | Active, not recruiting |
| Magdeburger Company For Medical Studies & Services GmbH Coordinator of this site? Confirm its status | Magdeburg | Germany | Active, not recruiting |
| BAG Dres. med. Quist PartG Coordinator of this site? Confirm its status | Mainz | Germany | Active, not recruiting |
| Nihonbashi Sakura Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Fukuwa Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Osaka Metropolitan University Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Medical Corporation Heishinkai OPHAC Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Naoko Dermatology Clinic Coordinator of this site? Confirm its status | Setagaya-ku | Japan | Unknown status |
| Nomura Dermatology Clinic Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Synexus Polska Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Active, not recruiting |
| Provita Sp z o o Coordinator of this site? Confirm its status | Katowice | Poland | Active, not recruiting |
| Zdybski Med Sp. z o. o. Coordinator of this site? Confirm its status | Ostrowiec Świętokrzyski | Poland | Active, not recruiting |
| NIEPUBLICZNY ZAKLAD OPIEKI ZDROWOTNEJ ZESPOL PORADNI SPECJALISTYCZNYCH "TERMEDICA" Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Synexus Polska Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| AllerVie Clinical Research Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Renaissance Research and Medical Group Coordinator of this site? Confirm its status | Cape Coral | United States | Unknown status |
| Epic Medical Research - Oklahoma Coordinator of this site? Confirm its status | Chickasha | United States | Unknown status |
| Michigan Center for Research Company Coordinator of this site? Confirm its status | Clarkston | United States | Unknown status |
| Florida International Medical Research Coordinator of this site? Confirm its status | Coral Gables | United States | Unknown status |
| Dermatology Treatment and Research Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Revival Research Coordinator of this site? Confirm its status | Doral | United States | Unknown status |
| St. Jude Clinical Research Coordinator of this site? Confirm its status | Doral | United States | Unknown status |
| Empire Dermatology Coordinator of this site? Confirm its status | East Syracuse | United States | Unknown status |
| North Texas Center for Clinical Research Coordinator of this site? Confirm its status | Frisco | United States | Unknown status |
| AboutSkin Research, LLC Coordinator of this site? Confirm its status | Greenwood Village | United States | Unknown status |
| Alpesh D. Desai, DO PLLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Marvel Clinical Research Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| Maryland Laser Skin and Vein Coordinator of this site? Confirm its status | Hunt Valley | United States | Unknown status |
| Dawes Fretzin Clinical Research Group, LLC Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Clinical Partners LLC Coordinator of this site? Confirm its status | Johnston | United States | Unknown status |
| California Allergy and Asthma Medical Group Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Apex Clinical Research Center Coordinator of this site? Confirm its status | Mayfield Heights | United States | Unknown status |
| Velocity Clinical Research, Medford Coordinator of this site? Confirm its status | Medford | United States | Unknown status |
| Clinical Neuroscience Solutions, Inc. Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| SouthCoast Research Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Floridian Research Institute Llc Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Global Health Research Center, Inc. Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Southern Indiana Clinical trials Coordinator of this site? Confirm its status | New Albany | United States | Unknown status |
| University Dermatology Trials, INC. Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Private Practice - Dr. Bobby Buka Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Sadick Research Group Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Virginia Dermatology and Skin Cancer Center Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Ziaderm Research LLC Coordinator of this site? Confirm its status | North Miami Beach | United States | Unknown status |
| Northridge Clinical Trials Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| MI Skin Innovations Coordinator of this site? Confirm its status | Northville | United States | Unknown status |
| Profound Research LLC Coordinator of this site? Confirm its status | Oceanside | United States | Unknown status |
| Unity Clinical Research Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Skin Specialists, PC dba Schlessinger MD Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Clinical Neuroscience Solutions, Inc. Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Onyx Clinical Research - Peoria Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Paddington Testing Co Inc Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Onyx Clinical Research Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| DCT-Stone Oak, LLC dba Discovery Clinical Trials Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| West Dermatology La Jolla Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc. Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Spartanburg Medical Research Coordinator of this site? Confirm its status | Spartanburg | United States | Unknown status |
| GCP Research, Global Clinical professionals Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Complete Dermatology Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| ForCare Clinical Research Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Revival Research Institute, LLC Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
| Banner - University Medicine Dermatology Clinic Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Vital Prospects Clinical Research Institute., PC Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| Sunwise Clinical Research Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.