RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07029828

Registry updated: 2026-10-15

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Description

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.

Interventions

Ritlecitinib higher dose (Drug)
Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
Ritlecitinib lower dose (Drug)
Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.

Eligibility criteria

Inclusion Criteria: 1. Participants with alopecia areata (AA) (including alopecia totalis \[AT\] and alopecia universalis \[AU\]) who completed the studies B7981027 or B7981031. 2. For participants originating from Study B7981031: At least 50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the Screening and Baseline visits. Exclusion Criteria: 1. Exclusion criteria for participants originating from Study B7981027 with ≤ 30 Days between last dose in Study B7981027 and first visit of Study B7981028 1. During Study B7981027 or in the period between the last dose of study intervention in Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol. 2. Study participants discontinued from Study B7981027 due to issues other than safety-related events and considered by the investigator for enrolment in Study B7981028 must have resolution of the issue(s) resulting in discontinuation from the parent study prior to enrolment in Study B7981028. 2. Exclusion criteria for participants originating from Study B7981031 or from Study B7981027 with \>30 Days between last dose in Study B7981027 and first visit of Study B7981028 1. During Study B7981031 or Study B7981027 or in the period between the last dose of study intervention in Study B7981031 or Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol. 2. Any present malignancies or history of malignancies or lymphoproliferative disorders. 3. Evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection, history (one or more episodes) of severe or serious cytomegalovirus (CMV), herpes zoster (shingles) or disseminated herpes simplex, infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). \-

Conditions

Severe Alopecia Areata

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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