RECRUITING Phase 2 ClinicalTrials.gov

A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07216027

Registry updated: 2026-10-13

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Description

The purpose of this study is to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as eczema, or atopic eczema. People with this condition may have severe itching and rashes on the skin. The study is seeking participants who: 1. Are 18 to 64 years of age; 2. Were confirmed to have AD at least 6 months ago; 3. Do not have a suitable prescribed medicine for AD; 4. Are considered by their doctors to have moderate to severe AD. The study has two stages (Stage 1 and Stage 2). In both stages, eligible participants will take either PF-08049820 or placebo as tablets by mouth daily for 12 weeks. A placebo does not have any medicine in it but looks just like the medicine being studied. Participants will visit the clinic on Day 1, Weeks 1, 2, 4, 6, 8 and 12. They will have a follow-up visit at Week 16. During this time, the participant's health and skin condition will be checked. They will have blood and urine tests. They will also have to answer questions about their health, skin condition, and how much their skin condition affects their lives. The experiences of participants receiving the study medicine will be compared to those receiving placebo. This will help to understand if PF-08049820 is safe and effective.

Interventions

PF-08049820 (Drug)
Tablet
Placebo (Drug)
Tablet

Eligibility criteria

Inclusion Criteria: Participants must meet the following criteria: 1. Are 18 to 64 years of age 2. Have clinical diagnosis of AD for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs 3. Have moderate to severe AD as defined by the following at screening and baseline visits: * Affected body surface area (BSA) greater than or equal to 10% and up to 60%; * Validated Investigator's Global Assessment (vIGA) greater than or equal to 3; * Eczema Area and Severity Index (EASI) greater than or equal to 16; AND -Peak Pruritis Numeric Rating Scale (PP-NRS) greater than or equal to 4 at screening and a weekly average of greater than or equal to 4 at baseline visit 4. Do not have a suitable prescribed medicine for AD. 5. Body Mass Index (BMI) of 18 to 38 kg/m2 and a total body weight greater than 48 kg (106 lbs) Exclusion Criteria: Participants must not meet the following criteria: 1. Have an infection that requires treatment 2. Have other skin conditions other than AD 3. Have severe uncontrolled asthma 4. Regular use (more than 2 visits per week) of a tanning booth or phototherapy for AD within 4 weeks of the screening visit

Conditions

Atopic Dermatitis Eczema, Atopic

Locations

Mayo Clinic Hospital — Phoenix, Arizona, United States
Mayo Clinic Specialty Building — Phoenix, Arizona, United States
Mayo Clinic — Scottsdale, Arizona, United States
Marvel Clinical Research — Huntington Beach, California, United States
Metropolis Dermatology - DTLA — Los Angeles, California, United States
Northridge Clinical Trials — Northridge, California, United States
Clinical Science Institute — Santa Monica, California, United States
Gsi Clinical Research — Margate, Florida, United States
Skin Research of South Florida — Miami, Florida, United States
Montefiore - Jacobi Dermatology Clinic — The Bronx, New York, United States
Montefiore - Clinical Research Center — The Bronx, New York, United States
Montefiore - Greene Medical Arts Pavillion — The Bronx, New York, United States
Montefiore - The Dermatology Center — The Bronx, New York, United States
Montefiore Medical Center — The Bronx, New York, United States
Apex Clinical Research Center, LLC. — Mayfield Heights, Ohio, United States
Paddington Testing Co, Inc — Philadelphia, Pennsylvania, United States
UPMC Department of Dermatology — Pittsburgh, Pennsylvania, United States
ASMC - IPSMC - skin and venereal diseases — Sofia, Sofia (stolitsa), Bulgaria
Toronto Research Centre — Toronto, Ontario, Canada
Centre de Recherche Saint-Louis inc. — Québec, Canada
The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China
Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China
Peking University People's Hospital — Beijing, China
DERMAMEDICA s.r.o. — Náchod, Czechia
CCR Ostrava, s.r.o. — Ostrava, Czechia
Pratia Czech s.r.o. — Pardubice, Czechia
Pratia Czech s.r.o. — Prague, Czechia
Hopital Saint Louis — Paris, France
Hopital Charles Nicolle — Rouen, France
Hopital Larrey — Toulouse, France
Hattori Dermatology Clinic — Takasaki, Gunma, Japan
Kosugi Dermatology Clinic — Kawasaki-shi, Kanagawa, Japan
Queen's square Medical Facilities Queen's square Dermatology and Allergology — Yokohama, Kanagawa, Japan
Dermatology and Ophthalmology Kume Clinic — Sakai, Osaka, Japan
Nihonbashi Sakura Clinic — Chuo-ku, Tokyo, Japan
Fukuwa Clinic — Chuo-ku, Tokyo, Japan
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o. — Krakow, Lesser Poland Voivodeship, Poland
Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki — Szczecin, West Pomeranian Voivodeship, Poland
Centrum Medyczne Angelius Provita — Katowice, Poland
Centrum Nowoczesnych Terapii Dobry Lekarz spółka z ograniczoną odpowiedzialnością — Krakow, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne — Szczecin, Poland

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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