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

NCT ID: NCT07216027

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-26

Study Completion Date

2027-08-23

Brief Summary

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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 years of age or more;
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.

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, and have a follow-up visit at Week 16. During this time, the participant's health and skin condition will be checked. Participants will have blood and urine tests and must 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 participants receiving placebo. This will help to understand if PF-08049820 is safe and effective.

Detailed Description

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Conditions

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Atopic Dermatitis Eczema, Atopic

Keywords

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Eczema Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Tablets taken by mouth daily for 12 weeks

Group Type EXPERIMENTAL

PF-08049820

Intervention Type DRUG

Tablet

Arm 2

Tablets taken by mouth daily for 12 weeks

Group Type EXPERIMENTAL

PF-08049820

Intervention Type DRUG

Tablet

Arm 3

Tablets taken by mouth daily for 12 weeks

Group Type EXPERIMENTAL

PF-08049820

Intervention Type DRUG

Tablet

Arm 4

Tablets taken by mouth daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet

Arm 5 (Optional)

Tablets taken by mouth daily for 12 weeks

Group Type EXPERIMENTAL

PF-08049820

Intervention Type DRUG

Tablet

Arm 6 (Optional)

Tablets taken by mouth daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet

Interventions

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PF-08049820

Tablet

Intervention Type DRUG

Placebo

Tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Central Contacts

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Pfizer CT.gov Call Center

Role: CONTACT

Phone: 1-800-718-1021

Email: [email protected]

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C6231002

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

Other Identifiers

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2025-522965-31-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

C6231002

Identifier Type: -

Identifier Source: org_study_id