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

NCT07029828 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: B79810282024-515439-31-00
• Study Type: interventional
• Target: 140
• Locations: 6 countries
• Sites: 41

Brief Summary

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.

Conditions

Severe Alopecia Areata

Keywords

Alopecia Areata; Children; Ritlecitinib; Long-term extension study

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-emergent adverse events (AEs).

  From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 3 years).

• Incidence of Serious Adverse Events (SAEs) and AEs leading to permanent discontinuation from the study.

  From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 3 years).

Secondary Outcomes (10)

• Proportion of participants achieving absolute Severity of Alopecia Tool (SALT) score ≤10.

  Months 3,6,9,12,15,18,21,24,27,30,33 and 36.

• Proportion of participants achieving absolute SALT score ≤20.

  Months 3,6,9,12,15,18,21,24,27,30,33 and 36.

• Change from baseline (CFB) in SALT score.

  Baseline, Months 3,6,9,12,15,18,21,24,27,30,33 and 36.

• Proportion of participants achieving at least 2 grade improvement or a score of 3 in eyebrow assessment (EBA) score in participants with an abnormal EBA at baseline.

  Months 3,6,9,12,15,18,21,24,27,30,33 and 36.

• Proportion of participants achieving at least 2 grade improvement or a score of 3 in eyelash assessment (ELA) score in participants with an abnormal ELA at baseline.

  Months 3,6,9,12,15,18,21,24,27,30,33 and 36.

Other Outcomes (1)

• CFB in Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Depressive Symptoms T-score.

  Baseline, Months 3,6,9,12,15,18,21,24,27,30,33 and 36.

Study Arms (2)

Ritlecitinib higher dose

EXPERIMENTAL

Participants will receive 1 ritlecitinib higher dose capsule once a day (QD) and 1 placebo lower dose capsule QD orally for up to 3 years. Participants who meet the protocol-defined treatment discontinuation criteria based on not achieving the required efficacy threshold will be switched to placebo but will remain in the study. Those participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD.

Drug: Ritlecitinib higher dose

Ritlecitinib lower dose

EXPERIMENTAL

Participants will receive 1 ritlecitinib lower dose capsule once a day (QD) and 1 placebo higher dose capsule QD orally for up to 3 years. Participants who meet the protocol-defined treatment discontinuation criteria based on not achieving the required efficacy threshold will be switched to placebo but will remain in the study. Those participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD.

Drug: Ritlecitinib lower dose

Interventions

Ritlecitinib higher dose DRUG

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

Ritlecitinib higher dose

Ritlecitinib lower dose DRUG

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

Ritlecitinib lower dose

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants with alopecia areata (AA) (including alopecia totalis \[AT\] and alopecia universalis \[AU\]) who completed the studies B7981027 or B7981031.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• Any present malignancies or history of malignancies or lymphoproliferative disorders.
• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (41)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

RECRUITING

Pediatric Skin Research

Miami, Florida, 33156, United States

RECRUITING

D&H Tamarac Research Center

Tamarac, Florida, 33321, United States

NOT YET RECRUITING

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

RECRUITING

Kindred Hair and Skin Center

Marriottsville, Maryland, 21104, United States

NOT YET RECRUITING

Michigan Dermatology Institute

Waterford, Michigan, 48328, United States

NOT YET RECRUITING

Ear, Nose & 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, LLC

The Bronx, New York, 10455, United States

NOT YET RECRUITING

Northwest Dermatology Institute

Portland, Oregon, 97210, United States

RECRUITING

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

NOT YET RECRUITING

Medical University of South Carolina Department of Dermatology and Dermatologic Surgery

Charleston, South Carolina, 29425, United States

NOT YET RECRUITING

3A Research

El Paso, Texas, 79902, United States

RECRUITING

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Prof. MUDr. Petr Arenberger, DrSc., MBA

Prague, 11000, Czechia

NOT YET RECRUITING

Hospices Civils de Lyon - Hopital Femme Mere Enfant

Bron, 69500, France

NOT YET RECRUITING

CHU de Dijon Bourgogne

Dijon, 21079, France

NOT YET RECRUITING

GHICL - Service d'investigation - Recherche clinique

Lille, 59000, France

NOT YET RECRUITING

Hôpital Saint Vincent de Paul

Lille, 59020, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Nice

Nice, 06202, France

NOT YET RECRUITING

Hôpitaux Drôme Nord

Romans-sur-Isère, 26100, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey

Toulouse, 31400, France

NOT YET RECRUITING

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

NOT YET RECRUITING

Hamamatsu University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

RECRUITING

Kyorin University Hospital

Mitaka, Tokyo, 181-8611, Japan

NOT YET RECRUITING

Osaka Metropolitan University Hospital

Osaka, 545-8586, Japan

RECRUITING

Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

NOT YET RECRUITING

DERMEDIC Iwona Zdybska

Lublin, Lublin Voivodeship, 20-607, Poland

NOT YET RECRUITING

Klinika Osipowicz & Turkowski

Warsaw, Masovian Voivodeship, 00-716, Poland

NOT YET RECRUITING

Państwowy Instytut Medyczny MSWiA

Warsaw, Masovian Voivodeship, 02-507, Poland

NOT YET RECRUITING

Provita Poliklinika

Warsaw, Masovian Voivodeship, 02-647, Poland

NOT YET RECRUITING

Klinika Ambroziak Dermatologia

Warsaw, Masovian Voivodeship, 02-953, Poland

NOT YET RECRUITING

Royalderm Agnieszka Nawrocka

Warsaw, Masovian Voivodeship, 02-962, Poland

NOT YET RECRUITING

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, 40-611, 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

NOT YET 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): June 26, 2030
• Study Completion (Estimated): June 26, 2030
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

PL (10); CN (1); CZ (1); FR (7); JP (4); US (18)