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

NCT07216027 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: C62310022025-522965-31-00
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 10

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 years of age or more;
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.

Conditions

Atopic Dermatitis; Eczema, Atopic

Keywords

Eczema; Atopic 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 (5)

• 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

Study Arms (6)

Arm 1

EXPERIMENTAL

Tablets taken by mouth daily for 12 weeks

Drug: PF-08049820

Arm 2

EXPERIMENTAL

Tablets taken by mouth daily for 12 weeks

Drug: PF-08049820

Arm 3

EXPERIMENTAL

Tablets taken by mouth daily for 12 weeks

Drug: PF-08049820

Arm 4

PLACEBO COMPARATOR

Tablets taken by mouth daily for 12 weeks

Drug: Placebo

Arm 5 (Optional)

EXPERIMENTAL

Tablets taken by mouth daily for 12 weeks

Drug: PF-08049820

Arm 6 (Optional)

PLACEBO COMPARATOR

Tablets taken by mouth daily for 12 weeks

Drug: Placebo

Interventions

PF-08049820 DRUG

Tablet

Arm 1; Arm 2; Arm 3; Arm 5 (Optional)

Placebo DRUG

Tablet

Arm 4; Arm 6 (Optional)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet the following criteria:
• Are 18 years of age or older
• 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 17.5 to 40 kg/m2 and a total body weight greater than 45 kg (100 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (10)

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Gsi Clinical Research

Margate, Florida, 33063, United States

Location

Skin Research of South Florida

Miami, Florida, 33173, United States

Location

Goodlettsville Dermatology Research

Goodlettsville, Tennessee, 37072, United States

Location

Hattori Dermatology Clinic

Takasaki, Gunma, 370-0071, Japan

Location

Kosugi Dermatology Clinic

Kawasaki-shi, Kanagawa, 211-0063, Japan

Location

Queen's Square Medical Facilities

Yokohama, Kanagawa, 220-6208, Japan

Location

Dermatology and Ophthalmology Kume Clinic

Sakai, Osaka, 593-8324, Japan

Location

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo, 103-0025, Japan

Location

Fukuwa Clinic

Chuo-ku, Tokyo, 104-0031, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

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): August 23, 2027
• Study Completion (Estimated): August 23, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (4); JP (6)