臨床研究等提出・公開システム

A PHASE 2B, 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 (A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema)

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

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Pending

Feb. 04, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Inclusion Criteria:

Participants must meet the following criteria:

1.Are 18 years of age or older
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 17.5 to 40 kg/m2 and a total body weight greater than 45 kg (100 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

Both

*Atopic Dermatitis
*Eczema, Atopic

*Drug: PF-08049820
-Tablet
*Drug: Placebo
-Tablet

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

*Response based on achieving EASI75 (>=75% improvement from baseline) at scheduled time points [Time Frame: Day 1 through Week 16]
*Percent change from baseline in EASI total score at scheduled time points other than Week 12 [Time Frame: Day 1 through Week 16]
*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]
*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]
*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]

Dec. 04, 2025

Yes

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

United States