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RECRUITING
NCT07029711
PHASE3

A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata

Sponsor: Pfizer

View on ClinicalTrials.gov

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

Interventions

DRUG

Ritlecitinib higher dose

Study intervention will be provided as oral capsules centrally by the sponsor in high-density polyethylene (HDPE) bottles.

DRUG

Ritlecitinib lower dose

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

DRUG

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