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

NCT07029711 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: B79810272024-515438-33-00
• Study Type: interventional
• Target: 208
• Locations: 9 countries
• Sites: 80

Brief 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.

Conditions

Severe Alopecia Areata

Keywords

Alopecia areata; Children; Ritlecitinib

Outcome Measures

Primary Outcomes (2)

• For US and Countries Following US Analysis Plan: Response based on achieving an absolute Severity of Alopecia Tool (SALT) score ≤20.

  The difference in proportions of participants with the SALT ≤20 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.

  Week 24

• For EU/UK and Countries Following EU/UK Analysis Plan: Response based on achieving an absolute SALT score ≤10.

  The difference in proportions of participants with the SALT ≤10 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.

  Week 24

Secondary Outcomes (18)

• For EU/UK and Countries Following EU/UK Analysis Plan: Patient Global Impression of Change (PGI-C) response defined as a score of "moderately improved" or "greatly improved".

  Week 24

• For all countries: Change from baseline (CFB) in SALT score.

  Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.

• For all countries: Response based on achieving absolute SALT score ≤20 at all visits (except for that included as the primary endpoint).

  Week 2, Week 4, Week 8, Week 12, Week 18

• For all countries: Response based on achieving absolute SALT score ≤10 at all visits (except for that included as the primary endpoint).

  Week 2, Week 4, Week 8, Week 12, Week 18.

• For all countries: PGI-C response at all visits (except for that included as a key secondary endpoint).

  Week 2, Week 4, Week 8, Week 12, Week 18.

Study Arms (3)

Ritlecitinib higher dose

EXPERIMENTAL

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.

Drug: Ritlecitinib higher dose

Ritlecitinib lower dose

EXPERIMENTAL

Participants will receive 1 ritlecitinib lower dose capsule QD and 1 placebo higher dose capsule QD orally for 24 weeks.

Drug: Ritlecitinib lower dose

Placebo

PLACEBO COMPARATOR

Participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD orally for 24 weeks.

Drug: Placebo

Interventions

Ritlecitinib higher dose DRUG

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

Also known as: Active Treatment

Ritlecitinib higher dose

Ritlecitinib lower dose DRUG

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

Also known as: Active Treatment

Ritlecitinib lower dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Other (non-AA) types of alopecia, including any known congenital cause of AA.
• Pre-existing hearing loss.
• Any present or history of malignancies or lymphoproliferative disorder such as Epstein-Barr virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
• Clinically significant depression per PROMIS Parent Proxy Short Form - Depressive symptoms (T-score ≥70).
• Any evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection; history (one or more episodes) of severe or serious cytomegalovirus (CMV) infection, herpes zoster (shingles) or disseminated herpes simplex; infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
• Vaccination with live attenuated replication-competent vaccine within 6 weeks of first dose of study intervention.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (80)

UCI Dermatology Clinical Research

Irvine, California, 92697, United States

Location

Southern California Clinical Research

Santa Ana, California, 92701, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Pediatric Skin Research

Miami, Florida, 33156, United States

Location

Endeavor Health Clinical Operations

Evanston, Illinois, 60201, United States

Location

Endeavor Health Clinical Operations

Skokie, Illinois, 60077, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Kindred Hair and Skin Center

Marriottsville, Maryland, 21104, United States

Location

Michigan Dermatology Institute

Waterford, Michigan, 48328, United States

Location

Ear, Nose and Throat Consultants, LLC

Omaha, Nebraska, 68144, United States

Location

Skin Specialists, PC dba Schlessinger MD

Omaha, Nebraska, 68144, United States

Location

Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist)

Papillion, Nebraska, 68046, United States

Location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87102, United States

Location

University of New Mexico-IDS Pharmacy

Albuquerque, New Mexico, 87106, United States

Location

Regents of the University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Northwest Dermatology Institute

Portland, Oregon, 97210, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Medical University of South Carolina Department of Dermatology and Dermatologic Surgery

Charleston, South Carolina, 29425, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Dell Children's Medical Center

Austin, Texas, 78723, United States

Location

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

Location

3A Research - West Location

El Paso, Texas, 79902, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Children's Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Beijing Children's hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China

Location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100192, China

Location

Beijing Tongren Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

The Second Affiliated Hospital Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510140, China

Location

Hunan Children's Hospital

Changsha, Hunan, 410007, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Chengdu Women and Children Center Hospital

Chengdu, Sichuan, 610091, China

Location

Kunming Children's hospital

Kunming, Yunnan, 650103, China

Location

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, 310006, China

Location

Hangzhou Third Hospital

Hangzhou, Zhejiang, 310009, China

Location

China-Japan Friendship Hospital

Beijing, 100029, China

Location

Shanghai Children's Hospital

Shanghai, 200062, China

Location

Fakultní Nemocnice Brno

Brno, 613 00, Czechia

Location

Fakultní nemocnice Plzeň

Pilsen, 30599, Czechia

Location

Prof. MUDr. Petr Arenberger, DrSc., MBA

Prague, 11000, Czechia

Location

Fakultní nemocnice Bulovka

Praha 8 - Libeň, 180 81, Czechia

Location

Hospices Civils de Lyon - CIC - Hopital Louis Pradel

Bron, 69500, France

Location

Hospices Civils de Lyon - Hopital Femme Mere Enfant

Bron, 69500, France

Location

CHU de Dijon Bourgogne

Dijon, 21079, France

Location

GHICL - Service d'investigation - Recherche clinique

Lille, 59000, France

Location

GHICL - Hôpital Saint Vincent de Paul

Lille, 59020, France

Location

Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2

Nice, 06200, France

Location

Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey

Toulouse, 31400, France

Location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

Asst Spedali Civili Di Brescia

Brescia, 25123, Italy

Location

Policlinico "G. Rodolico

Catania, 95123, Italy

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Niigata University Medical & Dental Hospital

Niigata, Niigata, 951-8520, Japan

Location

Hamamatsu University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Kyorin University Hospital

Mitaka, Tokyo, 181-8611, Japan

Location

Osaka Metropolitan University Hospital

Osaka, 545-8586, Japan

Location

Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski s.c.

Krakow, Lesser Poland Voivodeship, 30-002, Poland

Location

Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

Location

DERMEDIC Iwona Zdybska

Lublin, Lublin Voivodeship, 20-607, Poland

Location

Klinika Osipowicz & Turkowski

Warsaw, Masovian Voivodeship, 00-716, Poland

Location

Państwowy Instytut Medyczny MSWiA

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Provita Poliklinika

Warsaw, Masovian Voivodeship, 02-647, Poland

Location

Klinika Ambroziak Dermatologia

Warsaw, Masovian Voivodeship, 02-953, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, Masovian Voivodeship, 02-962, Poland

Location

Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal"

Bialystok, Podlaskie Voivodeship, 15-453, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, 40-611, Poland

Location

Provita Sp. z o.o.

Katowice, Silesian Voivodeship, 40-611, Poland

Location

Labderm Essence Sp. Z o.o.

Ossy, Silesian Voivodeship, 42-624, Poland

Location

Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie

Rzeszów, 35-055, Poland

Location

Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak

Lodz, Łódź Voivodeship, 90-436, Poland

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Royal Alexandra Children's Hospital

Brighton, EAST Sussex, BN2 5BE, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, Greater London, SE1 7EH, United Kingdom

Location

Chelsea and Westminster Hospital NHS Foundation Trust

London, Greater London, SW10 9NH, United Kingdom

Location

Great Ormond Street Hospital For Children NHS Foundation Trust

London, Greater London, WC1N 3JH, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and their caregivers, Investigators and other site staff will be blinded to their assigned study intervention. Sponsor staff will be blinded to participants' assigned study intervention, except for sponsor staff involved in the assignment or distribution of study intervention and the provision noted below. Sponsor staff who are not directly involved with the conduct of this study will prepare analyses and documentation containing unblinded data while the study is ongoing
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): December 2, 2026
• Study Completion (Estimated): January 6, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (27); CN (14); CZ (4); FR (7); IT (3); GB (4); ES (2); JP (5); PL (14)