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
2 other identifiers
interventional
340
7 countries
98
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2023
Typical duration for phase_2
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2023
CompletedFirst Posted
Study publicly available on registry
August 16, 2023
CompletedStudy Start
First participant enrolled
August 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 8, 2027
May 4, 2026
April 1, 2026
3.2 years
July 26, 2023
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of participants achieving ≥75% improvement in EAS175 from baseline at week16.
EASI75 (≥75% improvement from baseline) at Week 16
Week 16
Secondary Outcomes (7)
The number and % of participants achieving vIGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at all scheduled time points
Screening through study completion, an average of 36 weeks.
The number and % of participants achieving EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16
All scheduled timepoints other than Week 16, screening through study completion, an average of 36 weeks.
The number and % of participants achieving a Percent change from baseline in EASI total score at scheduled time points
Screening through study completion, an average of 36 weeks.
The number and % of participants with treatment emergent AEs
Screening - Week 36
The number and % of participants with clinically significant changes in vital signs
Screening - Week 36
- +2 more secondary outcomes
Study Arms (14)
Stage 1_PF-07275315
EXPERIMENTALStage 1 PF-07275315 Injections over 12 weeks
Stage 1_PF-07264660
EXPERIMENTALStage 1 PF-07264660 Injections over 12 weeks
Stage 1_Placebo
EXPERIMENTALStage 1 Placebo Injections over 12 weeks
Stage 2_PF-07275315 _Dose A
EXPERIMENTALStage 2 PF-07275315 Injections over 12 weeks.
Stage 2_PF-07275315 _Dose B
EXPERIMENTALStage 2 PF-07275315 Injections over 12 weeks.
Stage 2_PF-07275315 _Dose C
EXPERIMENTALStage 2 PF-07275315 Injections over 12 weeks.
Stage 2_PF-07275315 _Dose D
EXPERIMENTALStage 2 PF-07275315 or PF-07264660 Injections over 12 weeks.
Stage 2_Placebo
EXPERIMENTALStage 2 Placebo Injections over 12 weeks.
Stage 3_Placebo+PF-07275315_Dose A
EXPERIMENTALStage 3 Placebo Injections for 16 weeks followed by PF-07275315 Injections for 16 weeks.
Stage 3_PF-07275315_Dose B
EXPERIMENTALStage 3 PF-07275315 Injections for 32 weeks.
Stage 4_PF-07264660_Dose A
EXPERIMENTALStage 4 PF-07264660 Injections for 12 weeks
Stage 4_PF-07264660_Dose B
EXPERIMENTALStage 4 PF-07264660 Injections for 12 weeks
Stage 4_PF-07264660_Dose C
EXPERIMENTALStage 4 PF-07264660 Injections for 12 weeks
Stage 4_Placebo
EXPERIMENTALStage 2 Placebo Injections for 12 weeks
Interventions
subcutaneous injection
subcutaneous injection
subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- \- 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.
- 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;
- 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.
- 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:
- 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).
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (98)
Allervie Clinical Research
Birmingham, Alabama, 35209, United States
Onyx Clinical Research - Peoria
Peoria, Arizona, 85381, United States
Medical Dermatology Specialists
Phoenix, Arizona, 85006, United States
Onyx Clinical Research
Phoenix, Arizona, 85050, United States
Banner - University Medicine Dermatology Clinic
Tucson, Arizona, 85718, United States
Marvel Clinical Research
Huntington Beach, California, 92647, United States
California Allergy and Asthma Medical Group
Los Angeles, California, 90025, United States
University Dermatology Trials, INC.
Newport Beach, California, 92660, United States
Northridge Clinical Trials
Northridge, California, 91325, United States
Profound Research LLC
Oceanside, California, 92056, United States
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
San Diego, California, 92121, United States
West Dermatology La Jolla
San Diego, California, 92121, United States
Sunwise Clinical Research
Walnut Creek, California, 94596, United States
AboutSkin Research, LLC
Greenwood Village, Colorado, 80111, United States
Renaissance Research and Medical Group
Cape Coral, Florida, 33991, United States
Florida International Medical Research
Coral Gables, Florida, 33134, United States
Revival Research
Doral, Florida, 33122, United States
St. Jude Clinical Research
Doral, Florida, 33172, United States
SouthCoast Research Center
Miami, Florida, 33136, United States
Floridian Research Institute Llc
Miami, Florida, 33179, United States
Global Health Research Center, Inc.
Miami Lakes, Florida, 33016, United States
Ziaderm Research LLC
North Miami Beach, Florida, 33162, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
GCP Research, Global Clinical professionals
St. Petersburg, Florida, 33705, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
Southern Indiana Clinical Trials
New Albany, Indiana, 47150, United States
Maryland Laser Skin and Vein
Hunt Valley, Maryland, 21030, United States
Michigan Center for Research Company
Clarkston, Michigan, 48346, United States
MI Skin Innovations
Northville, Michigan, 48167, United States
Revival Research Institute LLC
Troy, Michigan, 48084, United States
Skin Specialists, PC dba Schlessinger MD
Omaha, Nebraska, 68144, United States
Empire Dermatology
East Syracuse, New York, 13057, United States
Private Practice - Dr. Bobby Buka
New York, New York, 10012, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Sadick Research Group
New York, New York, 10075, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124, United States
Epic Medical Research - Oklahoma
Chickasha, Oklahoma, 73018, United States
Unity Clinical Research
Oklahoma City, Oklahoma, 73118, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136, United States
Velocity Clinical Research, Medford
Medford, Oregon, 97504, United States
Paddington Testing Co, Inc
Philadelphia, Pennsylvania, 19103, United States
Clinical Partners, LLC
Johnston, Rhode Island, 02919, United States
National Allergy and Asthma
North Charleston, South Carolina, 29420, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, 38119, United States
Dermatology Treatment and Research Center
Dallas, Texas, 75230, United States
North Texas Center for Clinical Research
Frisco, Texas, 75034, United States
Alpesh D. Desai, DO PLLC
Houston, Texas, 77008, United States
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78258, United States
Complete Dermatology
Sugar Land, Texas, 77479, United States
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia, 23502, United States
Australian Clinical Research Network
Sydney, New South Wales, NSW 2035, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
Fremantle Dermatology
Fremantle, Western Australia, 6160, Australia
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4, Canada
Medicor Research Inc
Greater Sudbury, Ontario, P3C 1X3, Canada
Sudbury Skin Clinique
Greater Sudbury, Ontario, P3C 1X8, Canada
Lima's Excellence in Allergy and Dermatology Research
Hamilton, Ontario, L8L 3C3, Canada
DermEdge Research
Mississauga, Ontario, L4Y 4C5, Canada
Toronto Research Centre
Toronto, Ontario, M3H 5Y8, Canada
INTERMED Groupe Sante
Chicoutimi, Quebec, G7H 7Y8, Canada
Centre de Recherche Saint-Louis inc.
Québec, G1W 4R4, Canada
Beijing Friendship Hospital Affiliate of Capital University
Beijing, Beijing Municipality, 100050, China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, 350005, China
Dongguan People's Hospital
Dongguan, Guangdong, 523109, China
Guangdong Province Dermatology Hospital
Guangzhou, Guangdong, 510091, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031, China
The Second Xiangya Hospital of Central South University
Changsha, Hu'nan, 410011, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, 330000, China
The first hospital of jilin university
Changchun, Jilin, 130021, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Chengdu second people's hospital
Chengdu, Sichuan, 610017, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Hangzhou Third Hospital
Hangzhou, Zhejiang, 310009, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
Shanghai First People's Hospital
Shanghai, 201620, China
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, 48455, Germany
BAG Drs. Med. Quist PartG
Mainz, Rhineland-Palatinate, 55128, Germany
Magdeburger Company for Medical Studies and Services
Magdeburg, Saxony-Anhalt, 39104, Germany
Nomura Dermatology Clinic
Yokohama, Kanagawa, 221-0825, Japan
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Osaka, 532-0003, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-8586, Japan
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, 103-0025, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031, Japan
Naoko Dermatology Clinic
Setagaya-ku, Tokyo, 158-0097, Japan
Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica"
Poznan, Greater Poland Voivodeship, 60-681, Poland
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, 30-727, Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 50-381, Poland
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, 40-611, Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, 40-040, Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2023
First Posted
August 16, 2023
Study Start
August 22, 2023
Primary Completion (Estimated)
October 19, 2026
Study Completion (Estimated)
March 8, 2027
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.