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NCT Number: NCT07216027

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Eczema, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre de Recherche Saint-Louis inc., Québec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants must meet the following criteria:

  • Are 18 to 64 years of age
  • Have clinical diagnosis of AD for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs
  • 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

  • Do not have a suitable prescribed medicine for AD.
  • 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:

  • Have an infection that requires treatment
  • Have other skin conditions other than AD
  • Have severe uncontrolled asthma
  • Regular use (more than 2 visits per week) of a tanning booth or phototherapy for AD within 4 weeks of the screening visit

Treatment and study plan

PF-08049820

Drug

Tablet

Placebo

Drug

Tablet

Primary outcomes

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

    Time frame: Week 12

Secondary outcomes

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

    Time frame: Day 1 through Week 16

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

    Time frame: Day 1 through Week 16

  3. 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

    Time frame: Day 1 through Week 16

  4. 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

    Time frame: Day 1 through Week 16

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

    Time frame: Day 1 through Week 16

  6. Change from baseline in biomarker at scheduled time points

    Time frame: Day 1 through Week 16

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 14, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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