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

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.

Brief Title

Categories

Immune System

Skin/Dermatology

Central Contacts

Central Contact Role

Contact

Central Contact Phone

1-800-718-1021

Central Contact Email

ClinicalTrials.gov_Inquiries@pfizer.com

Completion Date

2028-02-02

Completion Date Type

Estimated

Conditions

ATOPIC DERMATITIS

ECZEMA, ATOPIC

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

Inclusion 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)

Gender

All

Gender Based

false

Keywords

Eczema

Atopic Dermatitis

Healthy Volunteers

No

Last Update Post Date

Mon, 08/17/2026 - 12:00

Last Update Post Date Type

Actual

Last Update Submit Date

Fri, 08/14/2026 - 12:00

Maximum Age

64 Years

Minimum Age

18 Years

NCT Id

NCT07216027

Org Class

Industry

Org Full Name

Pfizer

Org Study Id

C6231002

Overall Status

Recruiting

Phases

Phase 2

Primary Completion Date

Wed, 02/02/2028 - 12:00

Primary Completion Date Type

Estimated

Official Title

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08049820 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

Primary Outcomes

Outcome Measure

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

Outcome Time Frame

Week 12

Secondary Ids

Secondary Id

2025-522965-31-00

Secondary Id

2025

Secondary Outcomes

Outcome Time Frame

Day 1 through Week 16

Outcome Measure

Response based on achieving EASI75 (≥75% improvement from baseline) at scheduled time points

Outcome Time Frame

Day 1 through Week 16

Outcome Measure

Percent change from baseline in EASI total score at scheduled time points other than Week 12

Outcome Time Frame

Day 1 through Week 16

Outcome Measure

Response based on achieving Validated Investigator's Global Assessment (vIGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of >2 points at scheduled time points

Outcome Time Frame

Day 1 through Week 16

Outcome Measure

Response based on achieving ≥4 points of reduction from baseline in weekly averages of Peak Pruritus-Numerical Rating Scale (PP-NRS4) at scheduled time points

Outcome Time Frame

Day 1 through Week 16

Outcome Measure

Incidence of treatment emergent adverse events (AEs) and serious adverse events (SAEs), and clinically significant changes in laboratory tests, vital signs and ECGs

Outcome Time Frame

Day 1 through Week 16

Outcome Measure

Change from baseline in biomarker at scheduled time points