A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis
NCT ID: NCT05995964
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
340 participants
INTERVENTIONAL
2023-08-22
2026-12-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis
NCT02780167
A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
NCT05375955
Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
NCT03627767
Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis
NCT03915496
Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
NCT03349060
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stage 1_PF-07275315
Stage 1 PF-07275315 Injections over 12 weeks
PF-07275315
subcutaneous injection
Stage 1_PF-07264660
Stage 1 PF-07264660 Injections over 12 weeks
PF-07264660
subcutaneous injection
Stage 1_Placebo
Stage 1 Placebo Injections over 12 weeks
Placebo
subcutaneous injection
Stage 2_PF-07275315 _Dose A
Stage 2 PF-07275315 Injections over 12 weeks.
PF-07275315
subcutaneous injection
Stage 2_PF-07275315 _Dose B
Stage 2 PF-07275315 Injections over 12 weeks.
PF-07275315
subcutaneous injection
Stage 2_PF-07275315 _Dose C
Stage 2 PF-07275315 Injections over 12 weeks.
PF-07275315
subcutaneous injection
Stage 2_PF-07275315 _Dose D
Stage 2 PF-07275315 or PF-07264660 Injections over 12 weeks.
PF-07275315
subcutaneous injection
PF-07264660
subcutaneous injection
Stage 2_Placebo
Stage 2 Placebo Injections over 12 weeks.
Placebo
subcutaneous injection
Stage 3_Placebo+PF-07275315_Dose A
Stage 3 Placebo Injections for 16 weeks followed by PF-07275315 Injections for 16 weeks.
PF-07275315
subcutaneous injection
Placebo
subcutaneous injection
Stage 3_PF-07275315_Dose B
Stage 3 PF-07275315 Injections for 32 weeks.
PF-07275315
subcutaneous injection
Stage 4_PF-07264660_Dose A
Stage 4 PF-07264660 Injections for 12 weeks
PF-07264660
subcutaneous injection
Stage 4_PF-07264660_Dose B
Stage 4 PF-07264660 Injections for 12 weeks
PF-07264660
subcutaneous injection
Stage 4_PF-07264660_Dose C
Stage 4 PF-07264660 Injections for 12 weeks
PF-07264660
subcutaneous injection
Stage 4_Placebo
Stage 2 Placebo Injections for 12 weeks
Placebo
subcutaneous injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PF-07275315
subcutaneous injection
PF-07264660
subcutaneous injection
Placebo
subcutaneous injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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.
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Allervie Clinical Research
Birmingham, Alabama, United States
Onyx Clinical Research - Peoria
Peoria, Arizona, United States
Medical Dermatology Specialists
Phoenix, Arizona, United States
Onyx Clinical Research
Phoenix, Arizona, United States
Banner - University Medicine Dermatology Clinic
Tucson, Arizona, United States
Marvel Clinical Research
Huntington Beach, California, United States
California Allergy and Asthma Medical Group
Los Angeles, California, United States
University Dermatology Trials, INC.
Newport Beach, California, United States
Northridge Clinical Trials
Northridge, California, United States
Profound Research LLC
Oceanside, California, United States
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
San Diego, California, United States
Sunwise Clinical Research
Walnut Creek, California, United States
AboutSkin Research, LLC
Greenwood Village, Colorado, United States
Renaissance Research and Medical Group
Cape Coral, Florida, United States
Florida International Medical Research
Coral Gables, Florida, United States
Revival Research
Doral, Florida, United States
St. Jude Clinical Research
Doral, Florida, United States
SouthCoast Research Center
Miami, Florida, United States
Floridian Research Institute Llc
Miami, Florida, United States
Global Health Research Center, Inc.
Miami Lakes, Florida, United States
Ziaderm Research LLC
North Miami Beach, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
GCP Research, Global Clinical professionals
St. Petersburg, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Southern Indiana Clinical Trials
New Albany, Indiana, United States
Maryland Laser Skin and Vein
Hunt Valley, Maryland, United States
Michigan Center for Research Company
Clarkston, Michigan, United States
MI Skin Innovations
Northville, Michigan, United States
Revival Research Institute LLC
Troy, Michigan, United States
Revival Research Institute, LLC
Troy, Michigan, United States
Skin Specialists, PC dba Schlessinger MD
Omaha, Nebraska, United States
Empire Dermatology
East Syracuse, New York, United States
Private Practice - Dr. Bobby Buka
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Sadick Research Group
New York, New York, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, United States
Epic Medical Research - Oklahoma
Chickasha, Oklahoma, United States
Unity Clinical Research
Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, United States
Velocity Clinical Research, Medford
Medford, Oregon, United States
Paddington Testing Co, Inc
Philadelphia, Pennsylvania, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
National Allergy and Asthma
North Charleston, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
North Texas Center for Clinical Research
Frisco, Texas, United States
Alpesh D. Desai, DO PLLC
Houston, Texas, United States
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, United States
Complete Dermatology
Sugar Land, Texas, United States
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia, United States
Australian Clinical Research Network
Sydney, New South Wales, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Dr Rodney Sinclair Pty Ltd
East Melbourne, Victoria, Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
Medicor Research Inc
Greater Sudbury, Ontario, Canada
Sudbury Skin Clinique
Greater Sudbury, Ontario, Canada
Lima's Excellence in Allergy and Dermatology Research
Hamilton, Ontario, Canada
DermEdge Research
Mississauga, Ontario, Canada
Toronto Research Centre
Toronto, Ontario, Canada
INTERMED Groupe Sante
Chicoutimi, Quebec, Canada
Centre de Recherche Saint-Louis inc.
Québec, , Canada
Beijing Friendship Hospital Affiliate of Capital University
Beijing, Beijing Municipality, China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, China
Guangdong Province Dermatology Hospital
Guangzhou, Guangdong, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Xiangya Hospital of Central South University
Changsha, Hu'nan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, China
The first hospital of jilin university
Changchun, Jilin, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Hangzhou Third Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Chengdu second people's hospital
Chengdu, , China
Shanghai First People's Hospital
Shanghai, , China
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, Germany
BAG Drs. Med. Quist PartG
Mainz, Rhineland-Palatinate, Germany
Magdeburger Company for Medical Studies and Services
Magdeburg, Saxony-Anhalt, Germany
Nomura Dermatology Clinic
Yokohama, Kanagawa, Japan
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Osaka, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, Japan
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, Japan
Naoko Dermatology Clinic
Setagaya-ku, Tokyo, Japan
Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica"
Poznan, Greater Poland Voivodeship, Poland
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, , Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-505218-68-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4531002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.