Recruiting
Phase 2

PF-07275315 & PF-07264660

Sponsor:

Pfizer

Code:

NCT05995964

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-07275315

PF-07264660

Placebo

Study Details

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).

Conditions

Atopic Dermatitis

Study ID

NCT05995964

Start date

Aug 22, 2023

Status verified date

Apr, 2026

Completion date

Mar 8, 2027

Anticipated

Primary completion date

Oct 19, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

340 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stage 1 PF-07275315

Stage 1 PF-07275315 Injections over 12 weeks

experimental: Stage 1 PF-07264660

Stage 1 PF-07264660 Injections over 12 weeks

experimental: Stage 1 Placebo

Stage 1 Placebo Injections over 12 weeks

experimental: Stage 2 PF-07275315 Dose A

Stage 2 PF-07275315 Injections over 12 weeks.

experimental: Stage 2 PF-07275315 Dose B

Stage 2 PF-07275315 Injections over 12 weeks.

experimental: Stage 2 PF-07275315 Dose C

Stage 2 PF-07275315 Injections over 12 weeks.

experimental: Stage 2 PF-07275315 Dose D

Stage 2 PF-07275315 or PF-07264660 Injections over 12 weeks.

experimental: Stage 2 Placebo

Stage 2 Placebo Injections over 12 weeks.

experimental: Stage 3 Placebo+PF-07275315 Dose A

Stage 3 Placebo Injections for 16 weeks followed by PF-07275315 Injections for 16 weeks.

experimental: Stage 3 PF-07275315 Dose B

Stage 3 PF-07275315 Injections for 32 weeks.

experimental: Stage 4 PF-07264660 Dose A

Stage 4 PF-07264660 Injections for 12 weeks

experimental: Stage 4 PF-07264660 Dose B

Stage 4 PF-07264660 Injections for 12 weeks

experimental: Stage 4 PF-07264660 Dose C

Stage 4 PF-07264660 Injections for 12 weeks

experimental: Stage 4 Placebo

Stage 2 Placebo Injections for 12 weeks

Interventions

PF-07275315

subcutaneous injection

PF-07264660

subcutaneous injection

Placebo

subcutaneous injection

Primary outcome measure

  • The number of participants achieving ≥75% improvement in EAS175 from baseline at week16. [ Time Frame: Week 16 ]

Central Contacts and Locations

Central contacts

Locations

Allervie Clinical Research

Recruiting

Birmingham, Alabama, United States, 35209

Onyx Clinical Research - Peoria

Recruiting

Peoria, Arizona, United States, 85381

Medical Dermatology Specialists

Recruiting

Phoenix, Arizona, United States, 85006

Onyx Clinical Research

Recruiting

Phoenix, Arizona, United States, 85050

Banner - University Medicine Dermatology Clinic

Recruiting

Tucson, Arizona, United States, 85718

Marvel Clinical Research

Recruiting

Huntington Beach, California, United States, 92647

California Allergy and Asthma Medical Group

Recruiting

Los Angeles, California, United States, 90025

University Dermatology Trials, INC.

Recruiting

Newport Beach, California, United States, 92660

Northridge Clinical Trials

Recruiting

Northridge, California, United States, 91325

Profound Research LLC

Recruiting

Oceanside, California, United States, 92056

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

Recruiting

San Diego, California, United States, 92121

West Dermatology La Jolla

Recruiting

San Diego, California, United States, 92121

Revival Research

Recruiting

Doral, Florida, United States, 33122

Floridian Research Institute Llc

Recruiting

Miami, Florida, United States, 33179

Global Health Research Center, Inc.

Recruiting

Miami Lakes, Florida, United States, 33016

Ziaderm Research LLC

Recruiting

North Miami Beach, Florida, United States, 33162

Clinical Neuroscience Solutions, Inc.

Recruiting

Orlando, Florida, United States, 32801

GCP Research, Global Clinical professionals

Recruiting

St. Petersburg, Florida, United States, 33705

ForCare Clinical Research

Recruiting

Tampa, Florida, United States, 33613

Dawes Fretzin Clinical Research Group, LLC

Recruiting

Indianapolis, Indiana, United States, 46250

Southern Indiana Clinical Trials

Recruiting

New Albany, Indiana, United States, 47150

Maryland Laser Skin and Vein

Recruiting

Hunt Valley, Maryland, United States, 21030

Michigan Center for Research Company

Recruiting

Clarkston, Michigan, United States, 48346

MI Skin Innovations

Recruiting

Northville, Michigan, United States, 48167

Revival Research Institute LLC

Recruiting

Troy, Michigan, United States, 48084

Skin Specialists, PC dba Schlessinger MD

Recruiting

Omaha, Nebraska, United States, 68144

Empire Dermatology

Recruiting

East Syracuse, New York, United States, 13057

Private Practice - Dr. Bobby Buka

Recruiting

New York, New York, United States, 10012

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Sadick Research Group

Recruiting

New York, New York, United States, 10075

Apex Clinical Research Center

Recruiting

Mayfield Heights, Ohio, United States, 44124

Epic Medical Research - Oklahoma

Recruiting

Chickasha, Oklahoma, United States, 73018

Unity Clinical Research

Recruiting

Oklahoma City, Oklahoma, United States, 73118

Vital Prospects Clinical Research Institute, PC

Recruiting

Tulsa, Oklahoma, United States, 74136

Paddington Testing Co, Inc

Recruiting

Philadelphia, Pennsylvania, United States, 19103

Clinical Partners, LLC

Recruiting

Johnston, Rhode Island, United States, 02919

National Allergy and Asthma

Recruiting

North Charleston, South Carolina, United States, 29420

Spartanburg Medical Research

Recruiting

Spartanburg, South Carolina, United States, 29303

Clinical Neuroscience Solutions Inc.

Recruiting

Memphis, Tennessee, United States, 38119

Dermatology Treatment and Research Center

Recruiting

Dallas, Texas, United States, 75230

North Texas Center for Clinical Research

Recruiting

Frisco, Texas, United States, 75034

DCT-Stone Oak, LLC dba Discovery Clinical Trials

Recruiting

San Antonio, Texas, United States, 78258

Complete Dermatology

Recruiting

Sugar Land, Texas, United States, 77479

Wiseman Dermatology Research Inc.

Recruiting

Winnipeg, Manitoba, Canada, R3M 3Z4

Medicor Research Inc

Recruiting

Greater Sudbury, Ontario, Canada, P3C 1X3

Sudbury Skin Clinique

Recruiting

Greater Sudbury, Ontario, Canada, P3C 1X8

Lima's Excellence in Allergy and Dermatology Research

Recruiting

Hamilton, Ontario, Canada, L8L 3C3

DermEdge Research

Recruiting

Mississauga, Ontario, Canada, L4Y 4C5

Toronto Research Centre

Recruiting

Toronto, Ontario, Canada, M3H 5Y8

INTERMED Groupe Sante

Recruiting

Chicoutimi, Quebec, Canada, G7H 7Y8

Centre de Recherche Saint-Louis inc.

Recruiting

Québec, Canada, G1W 4R4

More Information

Sponsor

Pfizer

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • Eczema

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Pfizer on 2026-05-04.