RecruitingPhase 3NCT07733765

A Study in Young People and Adults to Learn About the Medicine Ritlecitinib for Treatment of Patchy Hair Loss, Known by the Medical Term as Moderate Alopecia Areata

A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH MODERATE ALOPECIA AREATA


Sponsor

Pfizer

Enrollment

336 participants

Start Date

Jul 30, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the potential treatment of moderate alopecia areata (AA). This study is seeking participants who are * 12 years or older (if permitted by the local IRB/EC and local regulatory health authority) * have AA with patchy hair loss. The current episode of hair loss has lasted for 6 months or longer but 10 years or less * do not have any other diseases or conditions affecting hair loss. Participants will have a 2 in 3 chance of receiving ritlecitinib 50 mg and a 1 in 3 chance of receiving placebo. The placebo looks like the study medicine but does not contain any active ingredients. Participants will not know what you have been assigned to receive. They will take ritlecitinib or placebo once daily by mouth at home for 24 weeks (6 months). After 24 weeks, the assigned treatment may stay the same or be changed to ritlecitinib 50 mg or 100 mg. This change will depend on how participants' alopecia areata responds to the treatment. Participants will receive the newly assigned treatment for another 23 weeks. About 4 weeks after the last dose, there will be a follow-up visit. At this visit, the team will check on your health. Participants will take part in this study for about 57 weeks. During this time, they will have study visits at the study clinic. Some study checks will be done by phone. We will compare the experiences of people receiving ritlecitinib to those of people who do not. This will help us determine if ritlecitinib is safe and effective.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo, a drug called Ritlecitinib 100 mg, and others for people with alopecia areata. The study is currently recruiting participants at 17 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRitlecitinib 100 mg

100 mg capsule taken orally once daily

DRUGRitlecitinib 50 mg

50 mg capsule taken orally once daily

OTHERPlacebo

Capsule matching either 50mg or 100 mg ritlecitinib capsule taken orally once daily


Locations(20)

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Skin Research of South Florida

Miami, Florida, United States

Endeavor Health

Skokie, Illinois, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Cutaneous Translational Research Program (CTReP)

Baltimore, Maryland, United States

Johns Hopkins Hospital Investigational Drug Services (IDS) Pharmacy

Baltimore, Maryland, United States

Revival Research Institute, LLC

Troy, Michigan, United States

Clinical and Translational Research Center (CTRC)

Chapel Hill, North Carolina, United States

UNC Dermatology and Skin Cancer Center

Chapel Hill, North Carolina, United States

Bexley Dermatology Research

Bexley, Ohio, United States

NW Dermatology Institute

Portland, Oregon, United States

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, United States

Center for Clinical Studies, LTD. LLP

Houston, Texas, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Dermatology Specialists of Spokane

Spokane, Washington, United States

Principle Research Solutions

Spokane, Washington, United States

Centre de Recherche Saint-Louis (Québec)

Québec, Quebec, Canada

Hospital of the University of Occupational and Environmental Health, Japan

Kitakyushu-shi, Fukuoka, Japan

Niigata University Medical & Dental Hospital

Niigata, Japan

View Full Details on ClinicalTrials.gov

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NCT07733765


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