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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

Status: Recruiting
Location: See all (77) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 11
Healthy Volunteers: f
View:

• A diagnosis of AA (including alopecia totalis (AT) and alopecia universalis (AU)) with at least 50% scalp hair loss due to AA (ie, SALT score of ≥50) at both screening and baseline visits, without evidence of terminal hair regrowth within the previous 12 months.

• For study participants in the EU/UK only: History of clinical response failure to AA treatment (such as topical, off-label pharmacologic, or hairpiece prosthetics)

• Documented evidence of having received varicella vaccination (2 doses), OR evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, a positive VZV Immunoglobulin G (IgG) antibody (Ab) result) at screening.

Locations
United States
California
California Dermatology & Clinical Research Institute
RECRUITING
Encinitas
University of California - Irvine
RECRUITING
Irvine
Investigational Drug Service - Rady Children's Hospital-San Diego
RECRUITING
San Diego
University of California, San Diego/Rady Children's Hospital-San Diego;
RECRUITING
San Diego
Southern California Clinical Research
RECRUITING
Santa Ana
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Washington, D.c.
Children's National Medical Center
RECRUITING
Washington D.c.
Florida
Pediatric Skin Research
RECRUITING
Miami
D&H Tamarac Research Center
RECRUITING
Tamarac
Illinois
Endeavor Health Clinical Operations
RECRUITING
Skokie
Indiana
Dawes Fretzin Clinical Research Group, LLC
RECRUITING
Indianapolis
Kentucky
Equity Medical - Bowling Green
RECRUITING
Bowling Green
Maryland
Kindred Hair and Skin Center
RECRUITING
Marriottsville
Michigan
Michigan Dermatology Institute
RECRUITING
Waterford
Minnesota
University of Minnesota Health Clinical Research Unit (M Health CRU)
RECRUITING
Minneapolis
Nebraska
Ear, Nose and Throat Consultants, LLC
RECRUITING
Omaha
Skin Specialists, PC dba Schlessinger MD
RECRUITING
Omaha
Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist)
RECRUITING
Papillion
New Mexico
Regents of the University of New Mexico
RECRUITING
Albuquerque
University of New Mexico Health Sciences Center
RECRUITING
Albuquerque
University of New Mexico-IDS Pharmacy
RECRUITING
Albuquerque
New York
Equity Medical
RECRUITING
New York
Oregon
Northwest Dermatology Institute
RECRUITING
Portland
Pennsylvania
Penn State Health Milton S. Hershey Medical Center
RECRUITING
Hershey
South Carolina
Medical University of South Carolina Department of Dermatology and Dermatologic Surgery
RECRUITING
Charleston
Texas
Driscoll Children's Hospital
RECRUITING
Corpus Christi
3A Research - West Location
ACTIVE_NOT_RECRUITING
El Paso
Austin Institute for Clinical Research
RECRUITING
Pflugerville
Texas Dermatology and Laser Specialists
RECRUITING
San Antonio
Other Locations
Canada
Laser Rejuvenation Clinics Edmonton D.T. Inc
RECRUITING
Edmonton
Medicine Professional Corporation
RECRUITING
Peterborough
CaRe Clinic
RECRUITING
Red Deer
Research Toronto
RECRUITING
Toronto
China
Beijing Children's hospital, Capital Medical University
RECRUITING
Beijing
Beijing Tongren Hospital affiliated to Capital Medical University
RECRUITING
Beijing
China-Japan Friendship Hospital
RECRUITING
Beijing
Hunan Children's Hospital
RECRUITING
Changsha
Xiangya Hospital Central South University
NOT_YET_RECRUITING
Changsha
Chengdu Women and Children Center Hospital
RECRUITING
Chengdu
The Second Affiliated Hospital Chongqing Medical University
RECRUITING
Chongqing
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Hangzhou Third Hospital
RECRUITING
Hangzhou
The First People's Hospital of Hangzhou
RECRUITING
Hangzhou
First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Kunming Children's hospital
NOT_YET_RECRUITING
Kunming
Huashan Hospital, Fudan University
RECRUITING
Shanghai
Shanghai Children's Hospital
RECRUITING
Shanghai
France
Hospices Civils de Lyon - CIC - Hopital Louis Pradel
RECRUITING
Bron
Centre Hospitalier de Dijon Bourgogne - Hôpital François Mitterrand
NOT_YET_RECRUITING
Dijon
GHICL - Hôpital Saint Vincent de Paul
NOT_YET_RECRUITING
Lille
GHICL - Service d'investigation - Recherche clinique
NOT_YET_RECRUITING
Lille
Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2
NOT_YET_RECRUITING
Nice
Hopital Enfants Malades Necker
NOT_YET_RECRUITING
Paris
Hôpitaux Drôme Nord - Romans
NOT_YET_RECRUITING
Romans-sur-isère
Italy
Asst Spedali Civili Di Brescia
NOT_YET_RECRUITING
Brescia
Japan
Hamamatsu University Hospital
RECRUITING
Hamamatsu
Kyorin University Hospital
RECRUITING
Mitaka
Niigata University Medical & Dental Hospital
RECRUITING
Niigata
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Tohoku University Hospital
RECRUITING
Sendai
Poland
Nzoz Specjalistyczny Ośrodek Dermatologiczny Dermal
RECRUITING
Bialystok
Centrum Medyczne Angelius Provita
RECRUITING
Katowice
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski s.c.
RECRUITING
Krakow
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
RECRUITING
Lodz
DERMEDIC Iwona Zdybska
RECRUITING
Lublin
Labderm Essence Sp. Z o.o.
NOT_YET_RECRUITING
Ossy
Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie
NOT_YET_RECRUITING
Rzeszów
Klinika Ambroziak Dermatologia
RECRUITING
Warsaw
Klinika Osipowicz & Turkowski
RECRUITING
Warsaw
Państwowy Instytut Medyczny MSWiA
RECRUITING
Warsaw
Provita Poliklinika
RECRUITING
Warsaw
Royalderm Agnieszka Nawrocka
RECRUITING
Warsaw
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
RECRUITING
Wroclaw
Spain
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
United Kingdom
Royal Alexandra Children's Hospital
RECRUITING
Brighton
Chelsea and Westminster Hospital NHS Foundation Trust
RECRUITING
London
Guy's and St Thomas' NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-07-31
Estimated Completion Date: 2027-05-18
Participants
Target number of participants: 225
Treatments
Experimental: Ritlecitinib higher dose
Participants will receive~1 ritlecitinib higher dose capsule once a day (QD) and 1 placebo lower dose capsule once a day (QD) orally for 24 weeks.
Experimental: Ritlecitinib lower dose
Participants will receive~1 ritlecitinib lower dose capsule QD and 1 placebo higher dose capsule QD orally for 24 weeks.
Placebo_comparator: Placebo
Participants will receive~1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD orally for 24 weeks.
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov