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A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Sponsor: Pfizer
Summary
The purpose of this study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the possible treatment of severe alopecia areata. Alopecia areata is a condition that causes hair loss. This study is seeking participants who have: * at least 50% scalp hair loss due to alopecia areata. * received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports. * history of clinical response failure to alopecia areata treatment (for children in EU/UK only). All participants in this study will receive either study medicine (ritlecitinib) or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. One-third of participants will receive ritlecitinib higher dose, one-third participants will receive ritlecitinib lower dose, and one-third participants will receive placebo. The study medicine is a capsule that is taken by mouth. It is taken once each day at home. The study will compare the experiences of participants receiving ritlecitinib to participants receiving placebo. This will help see if ritlecitinib is safe and effective. Participants will take part in this study for 6 months. During this time, they will have 8 study visits at the study clinic. The study team will also call participants about 8 times over the phone.
Official title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RITLECITINIB IN PEDIATRIC PARTICIPANTS 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA
Key Details
Gender
All
Age Range
6 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
225
Start Date
2025-07-31
Completion Date
2027-05-18
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Ritlecitinib higher dose
Study intervention will be provided as oral capsules centrally by the sponsor in high-density polyethylene (HDPE) bottles.
Ritlecitinib lower dose
Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
Placebo
Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
Locations (80)
California Dermatology & Clinical Research Institute
Encinitas, California, United States
University of California - Irvine
Irvine, California, United States
Investigational Drug Service - Rady Children's Hospital-San Diego
San Diego, California, United States
University of California, San Diego/Rady Children's Hospital-San Diego;
San Diego, California, United States
Southern California Clinical Research
Santa Ana, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Pediatric Skin Research
Miami, Florida, United States
D&H Tamarac Research Center
Tamarac, Florida, United States
Endeavor Health Clinical Operations
Skokie, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Equity Medical - Bowling Green
Bowling Green, Kentucky, United States
Kindred Hair and Skin Center
Marriottsville, Maryland, United States
Michigan Dermatology Institute
Waterford, Michigan, United States
University of Minnesota Health Clinical Research Unit (M Health CRU)
Minneapolis, Minnesota, United States
Ear, Nose and 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
New York, 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
Driscoll Children's Hospital
Corpus Christi, Texas, United States
3A Research - West Location
El Paso, Texas, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Laser Rejuvenation Clinics Edmonton D.T. Inc
Edmonton, Alberta, Canada
CaRe Clinic
Red Deer, Alberta, Canada
Medicine Professional Corporation
Peterborough, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
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
The Second Affiliated Hospital Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Hunan Children's Hospital
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Chengdu Women and Children Center Hospital
Chengdu, Sichuan, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Kunming Children's hospital
Kunming, Yunnan, China
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
Hangzhou Third Hospital
Hangzhou, Zhejiang, China
Shanghai Children's Hospital
Shanghai, China
Fakultni Nemocnice Plzen
Pilsen, Czechia
Prof. MUDr. Petr Arenberger, DrSc., MBA
Prague, Czechia
Fakultni nemocnice Bulovka
Prague, Czechia
Hospices Civils de Lyon - CIC - Hopital Louis Pradel
Bron, France
Centre Hospitalier de Dijon Bourgogne - Hôpital François Mitterrand
Dijon, France
GHICL - Service d'investigation - Recherche clinique
Lille, France
GHICL - Hôpital Saint Vincent de Paul
Lille, France
Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2
Nice, France
Hopital Enfants Malades Necker
Paris, France
Hôpitaux Drôme Nord - Romans
Romans-sur-Isère, France
Asst Spedali Civili Di Brescia
Brescia, Italy
Tohoku University Hospital
Sendai, Miyagi, Japan
Niigata University Medical & Dental Hospital
Niigata, Niigata, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Kyorin University Hospital
Mitaka, Tokyo, Japan
Osaka Metropolitan University Hospital
Osaka, 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
Państwowy Instytut Medyczny MSWiA
Warsaw, Masovian Voivodeship, Poland
Provita Poliklinika
Warsaw, Masovian Voivodeship, Poland
Klinika Ambroziak Dermatologia
Warsaw, Masovian Voivodeship, Poland
Royalderm Agnieszka Nawrocka
Warsaw, Masovian Voivodeship, Poland
Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal"
Bialystok, Podlaskie Voivodeship, Poland
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, Poland
Labderm Essence Sp. Z o.o.
Ossy, 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, 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