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

NCT07216027 · tracked via the Priya Life Science USA tracker

Sponsor

Pfizer

Phase

Phase 2

Started

2025-11-20

Last updated

2026-09-04

Condition(s) studied

Atopic DermatitisEczema, Atopic

Investigational drug(s) / intervention(s)

PF-08049820 →Placebo

PF-08049820: Tablet

Placebo: Tablet

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

64 Years

Healthy volunteers

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

Primary outcome measure(s)

Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 12 — Week 12

Trial sites (23)

Facility	City	Region	Status
Mayo Clinic in Arizona - Scottsdale	Scottsdale	Arizona	Not Yet Recruiting
Marvel Clinical Research	Huntington Beach	California	Recruiting
Metropolis Dermatology - DTLA	Los Angeles	California	Not Yet Recruiting
Northridge Clinical Trials	Northridge	California	Recruiting
Clinical Science Institute	Santa Monica	California	Active Not Recruiting
Gsi Clinical Research	Margate	Florida	Recruiting
Skin Research of South Florida	Miami	Florida	Active Not Recruiting
Montefiore - Jacobi Dermatology Clinic	The Bronx	New York	Recruiting
Montefiore - Clinical Research Center	The Bronx	New York	Recruiting
Montefiore - Greene Medical Arts Pavillion	The Bronx	New York	Recruiting
Montefiore - The Dermatology Center	The Bronx	New York	Recruiting
Montefiore Medical Center	The Bronx	New York	Recruiting
Paddington Testing Co, Inc	Philadelphia	Pennsylvania	Recruiting
UPMC Department of Dermatology	Pittsburgh	Pennsylvania	Recruiting
Centre de Recherche Saint-Louis inc.	Québec	Canada	Recruiting
Huashan Hospital, Fudan University	Shanghai	Shanghai Municipality	Recruiting
Peking University People's Hospital	Beijing	China	Not Yet Recruiting
Hattori Dermatology Clinic	Takasaki	Gunma	Recruiting
Kosugi Dermatology Clinic	Kawasaki-shi	Kanagawa	Recruiting
Queen's square Medical Facilities Queen's square Dermatology and Allergology	Yokohama	Kanagawa	Recruiting
Dermatology and Ophthalmology Kume Clinic	Sakai	Osaka	Recruiting
Nihonbashi Sakura Clinic	Chuo-ku	Tokyo	Recruiting
Fukuwa Clinic	Chuo-ku	Tokyo	Recruiting

More Pfizer trials in the USA

A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors Active, not recruiting

FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients Recruiting

Study to Evaluate the Safety and Efficacy of PF-06939926 for the Treatment of Duchenne Muscular Dystrophy Active, not recruiting

A Study in Young People and Adults to Learn About the Medicine Ritlecitinib for Treatment of Patchy Hair Loss, Known by the Medical Term as Moderate Alopecia Areata Recruiting

Effectiveness of ABRYSVO® Maternal Respiratory Syncytial Virus (RSV) Vaccine Against RSV in Infants in Western Pennsylvania Active, not recruiting

Other trials for the same condition

Real-world Experience Using Nemolizumab in the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents & Adults Recruiting

Phase 2a Study to Assess the Efficacy,Safety and Tolerability of GIA632 in Adult Participants With Moderate to Severe Atopic Dermatitis Active, not recruiting

FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients Recruiting

Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis Recruiting

Evaluate Efficacy and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07216027 on ClinicalTrials.gov ↗ ← All trials in the USA