RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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).

Official Title

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

Quick Facts

Study Start:2023-08-22

Study Completion:2026-12-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05995964

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center

STUDY_DIRECTOR

Pfizer

Study Locations (Sites)

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

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

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

Collaborators and Investigators

Sponsor: Pfizer

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-22

Study Completion Date2026-12-14

Study Record Updates

Study Start Date2023-08-22

Study Completion Date2026-12-14

Terms related to this study

Keywords Provided by Researchers

Eczema

Additional Relevant MeSH Terms

Atopic Dermatitis