RECRUITING

A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis

Description

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. 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 12 weeks. Stage 1 participants will receive shots at the study clinic on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12. Stage 2 participants will receive shots at the study clinic on Day 1, Week 4, Week 8 and Week 12. Stage 3 participants will receive shots at the study clinic on Day 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 28. 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 Stage 1 and 2 will be involved in this study for up to 40 weeks (10 months). During this time, Stage 1 participants will have 13 visits at the study clinic, and Stage 2 participants will have 9 visits at the study clinic. Participants in Stage 3 will be involved in this study for up to 52 weeks (13 months); and will have 13 visits at the study clinic.

Study Overview

Study Details

Study overview

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. 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 12 weeks. Stage 1 participants will receive shots at the study clinic on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12. Stage 2 participants will receive shots at the study clinic on Day 1, Week 4, Week 8 and Week 12. Stage 3 participants will receive shots at the study clinic on Day 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 28. 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 Stage 1 and 2 will be involved in this study for up to 40 weeks (10 months). During this time, Stage 1 participants will have 13 visits at the study clinic, and Stage 2 participants will have 9 visits at the study clinic. Participants in Stage 3 will be involved in this study for up to 52 weeks (13 months); and will have 13 visits at the study clinic.

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

A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis

Condition
Atopic Dermatitis
Intervention / Treatment

-

Contacts and Locations

Birmingham

Allervie Clinical Research, Birmingham, Alabama, United States, 35209

Peoria

Onyx Clinical Research - Peoria, Peoria, Arizona, United States, 85381

Phoenix

Medical Dermatology Specialists, Phoenix, Arizona, United States, 85006

Phoenix

Onyx Clinical Research, Phoenix, Arizona, United States, 85050

Tucson

Banner - University Medicine Dermatology Clinic, Tucson, Arizona, United States, 85718

Huntington Beach

Marvel Clinical Research, Huntington Beach, California, United States, 92647

Los Angeles

California Allergy and Asthma Medical Group, Los Angeles, California, United States, 90025

Newport Beach

University Dermatology Trials, INC., Newport Beach, California, United States, 92660

Northridge

Northridge Clinical Trials, Northridge, California, United States, 91325

Oceanside

Profound Research LLC, Oceanside, California, United States, 92056

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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, intolerance or AEs to anti-inflammatory proteins or loss of access to anti-inflammatory proteins.
  • 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.
  • 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2026-11-14