A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.

RECRUITING

NCT07029828

PHASE3

Sponsor: Pfizer

Summary

The purpose of this clinical trial is to learn about long-term safety and long-term effects of the study medicine (called ritlecitinib) for the potential treatment of severe alopecia areata, a condition that causes hair loss. This study is seeking participants who have: * previously completed one of Pfizer's pediatric studies for Alopecia Areata (B7981027 or B7981031). * at least 50% scalp hair loss due to alopecia areata (for participants enrolling from the study B7981031). * received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports. All participants in this study will receive the study medicine (ritlecitinib). Participants who received ritlecitinib higher or lower doses in the parent Study B7981027 will continue receiving the same ritlecitinib dose in this trial. Participants who received placebo in the parent Study B7981027 and all participants from parent Study B7981031 will receive either higher or lower dose of ritlecitinib in this trial. The study medicine is a capsule that is taken by mouth. It is taken 1 time each day at home. The study will help see if ritlecitinib is safe and effective. Participants will take part in this study for a duration of up to 3 years (36 months). During this time, they will have 17 study visits at the study clinic. The study team will also call participants once a month over the phone.

Official title: A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031

Key Details

Gender

All

Age Range

6 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-09-10

Completion Date

2030-06-26

Last Updated

2026-04-28

Healthy Volunteers

No

Conditions

Severe Alopecia Areata

Interventions

DRUG

Ritlecitinib higher dose

Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.

DRUG

Ritlecitinib lower dose

Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.

Locations (41)

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Pediatric Skin Research

Miami, Florida, United States

D&H Tamarac Research Center

Tamarac, Florida, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Kindred Hair and Skin Center

Marriottsville, Maryland, United States

Michigan Dermatology Institute

Waterford, Michigan, United States

Ear, Nose & Throat Consultants, LLC

Omaha, Nebraska, United States

Skin Specialists, PC dba Schlessinger MD

Omaha, Nebraska, United States

Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist)

Papillion, Nebraska, United States

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

University of New Mexico-IDS Pharmacy

Albuquerque, New Mexico, United States

Regents of the University of New Mexico

Albuquerque, New Mexico, United States

Equity Medical, LLC

The Bronx, New York, United States

Northwest Dermatology Institute

Portland, Oregon, United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Medical University of South Carolina Department of Dermatology and Dermatologic Surgery

Charleston, South Carolina, United States

3A Research

El Paso, Texas, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Prof. MUDr. Petr Arenberger, DrSc., MBA

Prague, Czechia

Hospices Civils de Lyon - Hopital Femme Mere Enfant

Bron, France

CHU de Dijon Bourgogne

Dijon, France

GHICL - Service d'investigation - Recherche clinique

Lille, France

Hôpital Saint Vincent de Paul

Lille, France

Centre Hospitalier Universitaire de Nice

Nice, France

Hôpitaux Drôme Nord

Romans-sur-Isère, France

Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey

Toulouse, France

Tohoku University Hospital

Sendai, Miyagi, Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Kyorin University Hospital

Mitaka, Tokyo, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Lower Silesian Voivodeship, Poland

DERMEDIC Iwona Zdybska

Lublin, Lublin Voivodeship, Poland

Klinika Osipowicz & Turkowski