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

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).

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: PF-07275315; Drug: PF-07264660; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 340
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, NSW 2035
      • Recruiting
      • Australian Clinical Research Network
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Recruiting
      • Box Hill Hospital
    • East Melbourne, Victoria, Australia, 3002
      • Recruiting
      • Sinclair Dermatology
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Recruiting
      • Fremantle Dermatology
• Canada
  • Québec, Canada, G1W 4R4
    • Recruiting
    • Centre de Recherche Saint-Louis inc.
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Recruiting
      • Wiseman Dermatology Research Inc.
  • Ontario
    • Greater Sudbury, Ontario, Canada, P3C 1X8
      • Recruiting
      • Sudbury Skin Clinique
    • Greater Sudbury, Ontario, Canada, P3C 1X3
      • Recruiting
      • Medicor Research Inc
    • Hamilton, Ontario, Canada, L8L 3C3
      • Recruiting
      • Lima's Excellence in Allergy and Dermatology Research
    • Mississauga, Ontario, Canada, L4Y 4C5
      • Recruiting
      • DermEdge Research
    • Toronto, Ontario, Canada, M3H 5Y8
      • Recruiting
      • Toronto Research Centre
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7Y8
      • Recruiting
      • INTERMED groupe santé
• China
  • Shanghai, China, 201620
    • Recruiting
    • Shanghai First People's Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100050
      • Recruiting
      • Beijing Friendship Hospital Affiliate of Capital University
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • Recruiting
      • The First Affiliated Hospital of Fujian Medical University
  • Guangdong
    • Dongguan, Guangdong, China, 523109
      • Not yet recruiting
      • Dongguan People's Hospital
    • Guangzhou, Guangdong, China, 510091
      • Recruiting
      • Guangdong Province Dermatology Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050031
      • Recruiting
      • The First Hospital of Hebei Medical University
  • Hu'nan
    • Changsha, Hu'nan, China, 410011
      • Recruiting
      • The Second Xiangya Hospital of Central South University
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Jiangsu
    • Zhenjiang, Jiangsu, China, 212001
      • Not yet recruiting
      • Affiliated Hospital of Jiangsu University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Recruiting
      • Dermatology Hospital of Jiangxi Province
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Recruiting
      • Huashan Hospital, Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610017
      • Recruiting
      • Chengdu Second People's Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Not yet recruiting
      • Tianjin Medical University General Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • Recruiting
      • First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Not yet recruiting
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China, 310016
      • Recruiting
      • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Hangzhou Third Hospital
• Germany
  • Lower Saxony
    • Bad Bentheim, Lower Saxony, Germany, 48455
      • Recruiting
      • Fachklinik Bad Bentheim
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55128
      • Recruiting
      • BAG Drs. Med. Quist PartG
  • Saxony-Anhalt
    • Magdeburg, Saxony-Anhalt, Germany, 39104
      • Recruiting
      • Magdeburger Company for Medical Studies and Services
• Japan
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 221-0825
      • Recruiting
      • Nomura Dermatology Clinic
  • Osaka
    • Osaka, Osaka, Japan, 545-8586
      • Recruiting
      • Osaka Metropolitan University Hospital
    • Osaka, Osaka, Japan, 532-0003
      • Active, not recruiting
      • Medical Corporation Heishinkai OPHAC Hospital
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Recruiting
      • Fukuwa Clinic
    • Chuo-ku, Tokyo, Japan, 103-0025
      • Recruiting
      • Nihonbashi Sakura Clinic
    • Setagaya-ku, Tokyo, Japan, 158-0097
      • Recruiting
      • Naoko Dermatology Clinic
• Poland
  • Katowice, Poland, 40-040
    • Recruiting
    • Synexus Polska Sp. Z O.O. Oddzial W Katowicach
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-681
      • Recruiting
      • Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica"
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-727
      • Recruiting
      • PRATIA MCM Kraków
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-381
      • Recruiting
      • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-611
      • Recruiting
      • Centrum Medyczne Angelius Provita
  • Świętokrzyskie Voivodeship
    • Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400
      • Recruiting
      • Dermedic Jacek Zdybski
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Recruiting
      • AllerVie Clinical Research
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Recruiting
      • Onyx Clinical Research - Peoria
    • Phoenix, Arizona, United States, 85006
      • Recruiting
      • Medical Dermatology Specialists
    • Phoenix, Arizona, United States, 85050
      • Recruiting
      • Onyx Clinical Research
    • Tucson, Arizona, United States, 85718
      • Recruiting
      • Banner - University Medicine Dermatology Clinic
  • California
    • Huntington Beach, California, United States, 92647
      • Recruiting
      • Marvel Clinical Research
    • Los Angeles, California, United States, 90025
      • Recruiting
      • California Allergy and Asthma Medical Group
    • Newport Beach, California, United States, 92660
      • Recruiting
      • University Dermatology Trials, INC.
    • Northridge, California, United States, 91325
      • Recruiting
      • Northridge Clinical Trials
    • Oceanside, California, United States, 92056
      • Recruiting
      • Profound Research LLC
    • San Diego, California, United States, 92121
      • Recruiting
      • Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
    • San Diego, California, United States, 92121
      • Recruiting
      • West Dermatology La Jolla
    • Walnut Creek, California, United States, 94596
      • Terminated
      • Sunwise Clinical Research
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Terminated
      • AboutSkin Research, LLC
  • Florida
    • Cape Coral, Florida, United States, 33991
      • Active, not recruiting
      • Renaissance Research and Medical Group
    • Coral Gables, Florida, United States, 33134
      • Terminated
      • Florida International Medical Research
    • Doral, Florida, United States, 33122
      • Recruiting
      • Revival Research
    • Doral, Florida, United States, 33172
      • Terminated
      • St. Jude Clinical Research
    • Miami, Florida, United States, 33179
      • Recruiting
      • Floridian Research Institute Llc
    • Miami, Florida, United States, 33136
      • Terminated
      • SouthCoast Research Center
    • Miami Lakes, Florida, United States, 33016
      • Recruiting
      • Global Health Research Center, Inc.
    • North Miami Beach, Florida, United States, 33162
      • Recruiting
      • Ziaderm Research LLC
    • Orlando, Florida, United States, 32801
      • Recruiting
      • Clinical Neuroscience Solutions, Inc.
    • St. Petersburg, Florida, United States, 33705
      • Recruiting
      • GCP Research, Global Clinical professionals
    • Tampa, Florida, United States, 33613
      • Recruiting
      • ForCare Clinical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Recruiting
      • Dawes Fretzin Clinical Research Group, LLC
    • New Albany, Indiana, United States, 47150
      • Recruiting
      • Southern Indiana Clinical trials
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
      • Recruiting
      • Maryland Laser Skin and Vein
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Recruiting
      • Michigan Center for Research Company
    • Northville, Michigan, United States, 48167
      • Recruiting
      • MI Skin Innovations
    • Troy, Michigan, United States, 48084
      • Recruiting
      • Revival Research Institute LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Recruiting
      • Skin Specialists, PC dba Schlessinger MD
  • New York
    • East Syracuse, New York, United States, 13057
      • Recruiting
      • Empire Dermatology
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10075
      • Recruiting
      • Sadick Research Group
    • New York, New York, United States, 10012
      • Recruiting
      • Private Practice - Dr. Bobby Buka
  • Ohio
    • Mayfield Heights, Ohio, United States, 44124
      • Recruiting
      • Apex Clinical Research Center
  • Oklahoma
    • Chickasha, Oklahoma, United States, 73018
      • Recruiting
      • Epic Medical Research - Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Recruiting
      • Unity Clinical Research
    • Tulsa, Oklahoma, United States, 74136
      • Recruiting
      • Vital Prospects Clinical Research Institute, PC
  • Oregon
    • Medford, Oregon, United States, 97504
      • Active, not recruiting
      • Velocity Clinical Research, Medford
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Recruiting
      • Paddington Testing Co, Inc
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Recruiting
      • Clinical Partners, LLC
  • South Carolina
    • North Charleston, South Carolina, United States, 29420
      • Recruiting
      • National Allergy and Asthma
    • Spartanburg, South Carolina, United States, 29303
      • Recruiting
      • Spartanburg Medical Research
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Recruiting
      • Clinical Neuroscience Solutions Inc.
  • Texas
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Dermatology Treatment and Research Center
    • Frisco, Texas, United States, 75034
      • Recruiting
      • North Texas Center for Clinical Research
    • Houston, Texas, United States, 77008
      • Active, not recruiting
      • Alpesh D. Desai, DO PLLC
    • San Antonio, Texas, United States, 78258
      • Recruiting
      • DCT-Stone Oak, LLC dba Discovery Clinical Trials
    • Sugar Land, Texas, United States, 77479
      • Recruiting
      • Complete Dermatology
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Terminated
      • Virginia Dermatology and Skin Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Must meet the following AD 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.

   Other Inclusion Criteria:

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:

- Medical Conditions:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

14

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1_PF-07275315; Stage 1 PF-07275315 Injections over 12 weeks	Drug: PF-07275315; subcutaneous injection
Experimental: Stage 1_PF-07264660; Stage 1 PF-07264660 Injections over 12 weeks	Drug: PF-07264660; subcutaneous injection
Experimental: Stage 1_Placebo; Stage 1 Placebo Injections over 12 weeks	Other: Placebo; subcutaneous injection
Experimental: Stage 2_PF-07275315 _Dose A; Stage 2 PF-07275315 Injections over 12 weeks.	Drug: PF-07275315; subcutaneous injection
Experimental: Stage 2_PF-07275315 _Dose B; Stage 2 PF-07275315 Injections over 12 weeks.	Drug: PF-07275315; subcutaneous injection
Experimental: Stage 2_PF-07275315 _Dose C; Stage 2 PF-07275315 Injections over 12 weeks.	Drug: PF-07275315; subcutaneous injection
Experimental: Stage 2_PF-07275315 _Dose D; Stage 2 PF-07275315 or PF-07264660 Injections over 12 weeks.	Drug: PF-07275315; subcutaneous injection; Drug: PF-07264660; subcutaneous injection
Experimental: Stage 2_Placebo; Stage 2 Placebo Injections over 12 weeks.	Other: Placebo; subcutaneous injection
Experimental: Stage 3_Placebo+PF-07275315_Dose A; Stage 3 Placebo Injections for 16 weeks followed by PF-07275315 Injections for 16 weeks.	Drug: PF-07275315; subcutaneous injection; Other: Placebo; subcutaneous injection
Experimental: Stage 3_PF-07275315_Dose B; Stage 3 PF-07275315 Injections for 32 weeks.	Drug: PF-07275315; subcutaneous injection
Experimental: Stage 4_PF-07264660_Dose A; Stage 4 PF-07264660 Injections for 12 weeks	Drug: PF-07264660; subcutaneous injection
Experimental: Stage 4_PF-07264660_Dose B; Stage 4 PF-07264660 Injections for 12 weeks	Drug: PF-07264660; subcutaneous injection
Experimental: Stage 4_PF-07264660_Dose C; Stage 4 PF-07264660 Injections for 12 weeks	Drug: PF-07264660; subcutaneous injection
Experimental: Stage 4_Placebo; Stage 2 Placebo Injections for 12 weeks	Other: Placebo; subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants achieving ≥75% improvement in EAS175 from baseline at week16.	EASI75 (≥75% improvement from baseline) at Week 16	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	Incidence of treatment emergent AEs	Screening - Week 36
The number and % of participants with clinically significant changes in vital signs	Incidence of clinically significant changes in vital signs	Screening - Week 36
The number and % of participants with clinically significant changes in ECG	Incidence of clinically significant changes in ECG	Screening - Week 36
The number and % of participants with clinically significant changes in laboratory tests	Incidence of clinically significant changes in laboratory tests	Screening - Week 36

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2023
• Primary Completion (Estimated): October 19, 2026
• Study Completion (Estimated): March 8, 2027

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Eczema
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Eczema
• Other Study ID Numbers: C4531002; 2023-505218-68-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No