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A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.
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
2026-10-15
Healthy Volunteers
No
Conditions
Interventions
Ritlecitinib higher dose
Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
Ritlecitinib lower dose
Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
Locations (67)
University of California~ Irvine
Irvine, California, United States
Southern California Clinical Research
Santa Ana, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
Pediatric Skin Research
Miami, Florida, United States
Endeavor Health Clinical Operations
Skokie, Illinois, 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
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
University of New Mexico-IDS Pharmacy
Albuquerque, New Mexico, 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 - South Carolina Translational Research Nexus Clinic
Charleston, South Carolina, United States
Dell Children's Medical Center
Austin, Texas, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
3A Research
El Paso, Texas, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Children's Wisconsin
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Beijing Children's hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tongren Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tongren Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Hunan Children's Hospital
Changsha, Hunan, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Chengdu Women and Children Center Hospital
Chengdu, Sichuan, China
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
Hangzhou Third Hospital
Hangzhou, Zhejiang, China
Fakultní Nemocnice Brno
Brno, Czechia
Fakultni Nemocnice Plzen
Pilsen, Czechia
Prof. MUDr. Petr Arenberger, DrSc., MBA
Prague, Czechia
Fakultni nemocnice Bulovka
Praha 8 - Libeň, Czechia
Hospices Civils de Lyon - CIC - Hopital Louis Pradel
Bron, France
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
Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey
Toulouse, France
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico S: Orsola
Bologna, BOLOGNA, Italy
Asst Spedali Civili Di Brescia
Brescia, BRESCIA, Italy
Tohoku University Hospital
Sendai, Miyagi, Japan
Niigata University Medical & Dental Hospital
Niigata, Niigata, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Kyorin University Hospital
Mitaka, Tokyo, Japan
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski s.c.
Krakow, Lesser Poland Voivodeship, Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
Wroclaw, Lower Silesian Voivodeship, Poland
DERMEDIC Iwona Zdybska
Lublin, Lublin Voivodeship, Poland
Klinika Osipowicz & Turkowski
Warsaw, Masovian Voivodeship, Poland
Provita Poliklinika
Warsaw, Masovian Voivodeship, Poland
Klinika Ambroziak Dermatologia
Warsaw, Masovian Voivodeship, Poland
Royalderm Agnieszka Nawrocka
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, Poland
Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie
Rzeszów, Poland
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Łódź Voivodeship, Poland
Hospital Universitario Miguel Servet
Zaragoza, Aragon, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, BARCELONA, Spain
Royal Alexandra Children's Hospital
Brighton, EAST SUSSEX, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, GREATER LONDON, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, GREATER LONDON, United Kingdom
University Hospitals Sussex NHS Foundation Trust (UHSussex)
Brighton, United Kingdom