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

NCT07029711 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: B79810272024-515438-33-00
• Study Type: interventional
• Target: 225
• Locations: 10 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)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

RECRUITING

University of California - Irvine

Irvine, California, 92617, United States

RECRUITING

Investigational Drug Service - Rady Children's Hospital-San Diego

San Diego, California, 92123, United States

RECRUITING

University of California, San Diego/Rady Children's Hospital-San Diego;

San Diego, California, 92123, United States

RECRUITING

Southern California Clinical Research

Santa Ana, California, 92701, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Children's National Medical Center

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

RECRUITING

Pediatric Skin Research

Miami, Florida, 33156, United States

RECRUITING

D&H Tamarac Research Center

Tamarac, Florida, 33321, United States

RECRUITING

Endeavor Health Clinical Operations

Skokie, Illinois, 60077, United States

RECRUITING

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

RECRUITING

Equity Medical - Bowling Green

Bowling Green, Kentucky, 42104, United States

RECRUITING

Kindred Hair and Skin Center

Marriottsville, Maryland, 21104, United States

RECRUITING

Michigan Dermatology Institute

Waterford, Michigan, 48328, United States

RECRUITING

University of Minnesota Health Clinical Research Unit (M Health CRU)

Minneapolis, Minnesota, 55455, United States

RECRUITING

Ear, Nose and Throat Consultants, LLC

Omaha, Nebraska, 68144, United States

RECRUITING

Skin Specialists, PC dba Schlessinger MD

Omaha, Nebraska, 68144, United States

RECRUITING

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

Papillion, Nebraska, 68046, United States

RECRUITING

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87102, United States

RECRUITING

University of New Mexico-IDS Pharmacy

Albuquerque, New Mexico, 87106, United States

RECRUITING

Regents of the University of New Mexico

Albuquerque, New Mexico, 87131, United States

RECRUITING

Equity Medical

New York, New York, 10455, United States

RECRUITING

Northwest Dermatology Institute

Portland, Oregon, 97210, United States

RECRUITING

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Medical University of South Carolina Department of Dermatology and Dermatologic Surgery

Charleston, South Carolina, 29425, United States

RECRUITING

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

RECRUITING

3A Research - West Location

El Paso, Texas, 79902, United States

ACTIVE NOT RECRUITING

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

RECRUITING

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

RECRUITING

Laser Rejuvenation Clinics Edmonton D.T. Inc

Edmonton, Alberta, T5J 3S9, Canada

RECRUITING

CaRe Clinic

Red Deer, Alberta, T4P 1K4, Canada

RECRUITING

Medicine Professional Corporation

Peterborough, Ontario, K9J 5K2, Canada

RECRUITING

Research Toronto

Toronto, Ontario, M4W 2N4, Canada

RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Beijing Children's hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China

RECRUITING

Beijing Tongren Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, 100730, China

RECRUITING

The Second Affiliated Hospital Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510140, China

RECRUITING

Hunan Children's Hospital

Changsha, Hunan, 410007, China

RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

NOT YET RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Chengdu Women and Children Center Hospital

Chengdu, Sichuan, 610091, China

RECRUITING

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

RECRUITING

Kunming Children's hospital

Kunming, Yunnan, 650103, China

NOT YET RECRUITING

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, 310006, China

RECRUITING

Hangzhou Third Hospital

Hangzhou, Zhejiang, 310009, China

RECRUITING

Shanghai Children's Hospital

Shanghai, 200062, China

RECRUITING

Fakultni Nemocnice Plzen

Pilsen, 305 99, Czechia

RECRUITING

Prof. MUDr. Petr Arenberger, DrSc., MBA

Prague, 11000, Czechia

RECRUITING

Fakultni nemocnice Bulovka

Prague, 180 81, Czechia

NOT YET RECRUITING

Hospices Civils de Lyon - CIC - Hopital Louis Pradel

Bron, 69500, France

RECRUITING

Centre Hospitalier de Dijon Bourgogne - Hôpital François Mitterrand

Dijon, 21000, France

NOT YET RECRUITING

GHICL - Service d'investigation - Recherche clinique

Lille, 59000, France

NOT YET RECRUITING

GHICL - Hôpital Saint Vincent de Paul

Lille, 59020, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2

Nice, 06200, France

NOT YET RECRUITING

Hopital Enfants Malades Necker

Paris, 75015, France

NOT YET RECRUITING

Hôpitaux Drôme Nord - Romans

Romans-sur-Isère, 26100, France

NOT YET RECRUITING

Asst Spedali Civili Di Brescia

Brescia, 25123, Italy

NOT YET RECRUITING

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

RECRUITING

Niigata University Medical & Dental Hospital

Niigata, Niigata, 951-8520, Japan

RECRUITING

Hamamatsu University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

RECRUITING

Kyorin University Hospital

Mitaka, Tokyo, 181-8611, Japan

RECRUITING

Osaka Metropolitan University Hospital

Osaka, 545-8586, Japan

RECRUITING

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

Krakow, Lesser Poland Voivodeship, 30-002, Poland

RECRUITING

Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

RECRUITING

DERMEDIC Iwona Zdybska

Lublin, Lublin Voivodeship, 20-607, Poland

RECRUITING

Klinika Osipowicz & Turkowski

Warsaw, Masovian Voivodeship, 00-716, Poland

RECRUITING

Państwowy Instytut Medyczny MSWiA

Warsaw, Masovian Voivodeship, 02-507, Poland

RECRUITING

Provita Poliklinika

Warsaw, Masovian Voivodeship, 02-647, Poland

RECRUITING

Klinika Ambroziak Dermatologia

Warsaw, Masovian Voivodeship, 02-953, Poland

RECRUITING

Royalderm Agnieszka Nawrocka

Warsaw, Masovian Voivodeship, 02-962, Poland

RECRUITING

Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal"

Bialystok, Podlaskie Voivodeship, 15-453, Poland

RECRUITING

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, 40-611, Poland

RECRUITING

Labderm Essence Sp. Z o.o.

Ossy, Silesian Voivodeship, 42-624, Poland

NOT YET RECRUITING

Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie

Rzeszów, 35-055, Poland

NOT YET RECRUITING

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

Lodz, Łódź Voivodeship, 90-436, Poland

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

Royal Alexandra Children's Hospital

Brighton, EAST Sussex, BN2 5BE, United Kingdom

RECRUITING

Guy's and St Thomas' NHS Foundation Trust

London, Greater London, SE1 7EH, United Kingdom

RECRUITING

Chelsea and Westminster Hospital NHS Foundation Trust

London, Greater London, SW10 9NH, United Kingdom

RECRUITING

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

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

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): April 20, 2027
• Study Completion (Estimated): May 18, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

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

Locations

US (29); CA (4); CN (14); CZ (3); FR (7); IT (1); GB (3); ES (1); JP (5); PL (13)