NCT07216027

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. 1.Are 18 to 64 years of age;
  2. 2.Were confirmed to have AD at least 6 months ago;
  3. 3.Do not have a suitable prescribed medicine for AD;
  4. 4.Are considered by their doctors to have moderate to severe AD.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for phase_2

Timeline
18mo left

Started Nov 2025

Geographic Reach
4 countries

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Nov 2025Feb 2028

First Submitted

Initial submission to the registry

October 9, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 14, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

November 20, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2028

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

2.2 years

First QC Date

October 9, 2025

Last Update Submit

July 27, 2026

Conditions

Eczema, AtopicAtopic Dermatitis

Keywords

EczemaAtopic Dermatitis

Outcome Measures

Primary Outcomes (1)

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

    Week 12

Secondary Outcomes (6)

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

    Day 1 through Week 16

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

    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

    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

    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

    Day 1 through Week 16

  • +1 more secondary outcomes

Study Arms (4)

Arm 2

EXPERIMENTAL

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

Drug: PF-08049820

Arm 3

EXPERIMENTAL

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

Drug: PF-08049820

Arm 1

EXPERIMENTAL

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

Drug: PF-08049820

Arm 4

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

PF-08049820DRUG

Tablet

Arm 1Arm 2Arm 3
PlaceboDRUG

Tablet

Arm 4

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Marvel Clinical Research

Huntington Beach, California, 92647, United States

RECRUITING

Metropolis Dermatology - DTLA

Los Angeles, California, 90017, United States

NOT YET RECRUITING

Northridge Clinical Trials

Northridge, California, 91325, United States

RECRUITING

Clinical Science Institute

Santa Monica, California, 90403, United States

ACTIVE NOT RECRUITING

Gsi Clinical Research

Margate, Florida, 33063, United States

RECRUITING

Skin Research of South Florida

Miami, Florida, 33173, United States

ACTIVE NOT RECRUITING

Montefiore - Jacobi Dermatology Clinic

The Bronx, New York, 10461, United States

RECRUITING

Montefiore - Clinical Research Center

The Bronx, New York, 10467, United States

RECRUITING

Montefiore - Greene Medical Arts Pavillion

The Bronx, New York, 10467, United States

RECRUITING

Montefiore - The Dermatology Center

The Bronx, New York, 10467, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Centre de Recherche Saint-Louis inc.

Québec, G1W 4R4, Canada

NOT YET RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Hattori Dermatology Clinic

Takasaki, Gunma, 370-0071, Japan

RECRUITING

Kosugi Dermatology Clinic

Kawasaki-shi, Kanagawa, 211-0063, Japan

RECRUITING

Queen's square Medical Facilities Queen's square Dermatology and Allergology

Yokohama, Kanagawa, 220-6208, Japan

RECRUITING

Dermatology and Ophthalmology Kume Clinic

Sakai, Osaka, 593-8324, Japan

RECRUITING

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo, 103-0025, Japan

RECRUITING

Fukuwa Clinic

Chuo-ku, Tokyo, 104-0031, Japan

RECRUITING

Related Links

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2025

First Posted

October 14, 2025

Study Start

November 20, 2025

Primary Completion (Estimated)

February 2, 2028

Study Completion (Estimated)

February 2, 2028

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

More information

Locations

CA(1)CN(1)US(12)JP(6)