Recruiting
Phase 2

PF-08049820

Sponsor:

Pfizer

Code:

NCT07216027

Conditions

Atopic Dermatitis

Eczema, Atopic

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

PF-08049820

Placebo

Study Details

Brief 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.

Conditions

Atopic Dermatitis

Eczema, Atopic

Study ID

NCT07216027

Start date

Nov 20, 2025

Status verified date

Sep, 2026

Completion date

Feb 2, 2028

Anticipated

Primary completion date

Feb 2, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

165 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 2

Stages 1 and 2: Tablets taken by mouth daily for 12 weeks

experimental: Arm 3

Stages 1 and 2: Tablets taken by mouth daily for 12 weeks

experimental: Arm 1

Stages 1 and 2: Tablets taken by mouth daily for 12 weeks

placebo comparator: Arm 4

Stages 1 and 2: Tablets taken by mouth daily for 12 weeks

Interventions

PF-08049820

Tablet

Placebo

Tablet

Primary outcome measure

  • Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 12 [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Locations

Marvel Clinical Research

Recruiting

Huntington Beach, California, United States, 92647

Northridge Clinical Trials

Recruiting

Northridge, California, United States, 91325

Gsi Clinical Research

Recruiting

Margate, Florida, United States, 33063

Montefiore - Jacobi Dermatology Clinic

Recruiting

The Bronx, New York, United States, 10461

Montefiore - Clinical Research Center

Recruiting

The Bronx, New York, United States, 10467

Montefiore - Greene Medical Arts Pavillion

Recruiting

The Bronx, New York, United States, 10467

Montefiore - The Dermatology Center

Recruiting

The Bronx, New York, United States, 10467

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Paddington Testing Co, Inc

Recruiting

Philadelphia, Pennsylvania, United States, 19103

UPMC Department of Dermatology

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Centre de Recherche Saint-Louis inc.

Recruiting

Québec, Canada, G1W 4R4

More Information

Sponsor

Pfizer

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Eczema
  • Atopic Dermatitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-09-04.