A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata (B7981027)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Severe Alopecia Areata
• Intervention / Treatment: Drug: Ritlecitinib lower dose; Drug: Ritlecitinib higher dose; Drug: Placebo

Detailed Description

Study B7981027 is being conducted to assess efficacy and safety of ritlecitinib in pediatric participants 6 to <12 years of age with severe AA. The primary objective of this study is to evaluate the efficacy of ritlecitinib compared to placebo in pediatric participants with severe AA on regrowth of lost scalp hair. The secondary objectives are to evaluate safety, tolerability, acceptability and palatability of ritlecitinib and to evaluate the effect of ritlecitinib on patient centered outcomes.

This study will have 3 treatment arms, including 2 ritlecitinib dosage levels (higher and lower doses) and 1 placebo arm. The participants will be assessed for study eligibility at the screening visit after informed consent/assent is obtained (as applicable).

Participants will receive study medication for a duration of 24 weeks.

At least 225 participants will be enrolled in the study. At least 30% of total study population will be recruited from Europe.

The efficacy assessments include Severity of Alopecia Tool (SALT), eyebrow and eyelash assessments. Patient reported outcomes including Patient's Global Impression of Change (PGI-C), Alopecia Areata Patient Priority Outcomes (AAPPO), Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy - Anxiety Short Form 8a and Depressive Symptoms Short Form 6a, Behavior Rating Inventory of Executive Function®, Second Edition (BRIEF®2), and modified Children's Dermatology Life Quality Index (CDLQI) will be assessed throughout the study. Pharmacokinetics of ritlecitinib will be evaluated using sparse sampling.

Safety monitoring will be performed to identify and monitor the known and potential risks of ritlecitinib.

Participants completing the 24-week treatment period of the study may have the option to enter the long-term extension (LTE) Study B7981028, if the eligibility criteria are met. Participants who complete the 24-week treatment period of the study but who are ineligible for the LTE study will undergo a 4-week off-treatment follow-up period.

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100029
    • China-Japan Friendship Hospital
  • Shanghai, China, 200062
    • Shanghai Children's Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100045
      • Beijing Children's hospital, Capital Medical University
    • Beijing, Beijing Municipality, China, 100730
      • Beijing Tongren Hospital affiliated to Capital Medical University
    • Beijing, Beijing Municipality, China, 100192
      • China-Japan Friendship Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400010
      • The Second Affiliated Hospital Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510140
      • The First Affiliated Hospital of Guangzhou Medical University
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University
    • Changsha, Hunan, China, 410007
      • Hunan Children's Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital, Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610091
      • Chengdu Women and Children Center Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650103
      • Kunming Children's hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • The First People's Hospital of Hangzhou
    • Hangzhou, Zhejiang, China, 310009
      • Hangzhou Third Hospital
• Czechia
  • Brno, Czechia, 613 00
    • Fakultni nemocnice Brno
  • Pilsen, Czechia, 30599
    • Fakultní nemocnice Plzen
  • Prague, Czechia, 11000
    • Prof. MUDr. Petr Arenberger, DrSc., MBA
  • Praha 8 - Libeň, Czechia, 180 81
    • Fakultní nemocnice Bulovka
• France
  • Bron, France, 69500
    • Hospices Civils de Lyon - Hopital Femme Mere Enfant
  • Bron, France, 69500
    • Hospices Civils de Lyon - CIC - Hopital Louis Pradel
  • Dijon, France, 21079
    • CHU de Dijon Bourgogne
  • Lille, France, 59000
    • GHICL - Service d'investigation - Recherche clinique
  • Lille, France, 59020
    • GHICL - Hôpital Saint Vincent de Paul
  • Nice, France, 06200
    • Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2
  • Toulouse, France, 31400
    • Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey
• Italy
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • Brescia, Italy, 25123
    • Asst Spedali Civili Di Brescia
  • Catania, Italy, 95123
    • Policlinico "G. Rodolico
• Japan
  • Osaka, Japan, 545-8586
    • Osaka Metropolitan University Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
  • Niigata
    • Niigata, Niigata, Japan, 951-8520
      • Niigata University Medical & Dental Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital
  • Tokyo
    • Mitaka, Tokyo, Japan, 181-8611
      • Kyorin University Hospital
• Poland
  • Rzeszów, Poland, 35-055
    • Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-002
      • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski s.c.
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-566
      • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-607
      • DERMEDIC Iwona Zdybska
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-507
      • Państwowy Instytut Medyczny MSWiA
    • Warsaw, Masovian Voivodeship, Poland, 02-953
      • Klinika Ambroziak Dermatologia
    • Warsaw, Masovian Voivodeship, Poland, 02-962
      • Royalderm Agnieszka Nawrocka
    • Warsaw, Masovian Voivodeship, Poland, 00-716
      • Klinika Osipowicz & Turkowski
    • Warsaw, Masovian Voivodeship, Poland, 02-647
      • Provita Poliklinika
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-453
      • Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal"
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-611
      • Centrum Medyczne Angelius Provita
    • Katowice, Silesian Voivodeship, Poland, 40-611
      • Provita Sp. z o.o.
    • Ossy, Silesian Voivodeship, Poland, 42-624
      • Labderm Essence Sp. Z o.o.
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 90-436
      • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
• Spain
  • Barcelona, Spain, 08025
    • Hospital de La Santa Creu I Sant Pau
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
• United Kingdom
  • EAST Sussex
    • Brighton, EAST Sussex, United Kingdom, BN2 5BE
      • Royal Alexandra Children's Hospital
  • Greater London
    • London, Greater London, United Kingdom, SE1 7EH
      • Guy's and St Thomas' NHS Foundation Trust
    • London, Greater London, United Kingdom, SW10 9NH
      • Chelsea and Westminster Hospital NHS Foundation Trust
    • London, Greater London, United Kingdom, WC1N 3JH
      • Great Ormond Street Hospital for Children NHS Foundation Trust
• United States
  • California
    • Irvine, California, United States, 92697
      • UCI Dermatology Clinical Research
    • Santa Ana, California, United States, 92701
      • Southern California Clinical Research
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • Miami, Florida, United States, 33156
      • Pediatric Skin Research
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Endeavor Health Clinical Operations
    • Skokie, Illinois, United States, 60077
      • Endeavor Health Clinical Operations
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
  • Maryland
    • Marriottsville, Maryland, United States, 21104
      • Kindred Hair and Skin Center
  • Michigan
    • Waterford, Michigan, United States, 48328
      • Michigan Dermatology Institute
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Ear, Nose and Throat Consultants, LLC
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC dba Schlessinger MD
    • Papillion, Nebraska, United States, 68046
      • Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • University of New Mexico Health Sciences Center
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico-IDS Pharmacy
    • Albuquerque, New Mexico, United States, 87131
      • Regents of the University of New Mexico
  • Oregon
    • Portland, Oregon, United States, 97210
      • Northwest Dermatology Institute
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Milton S. Hershey Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina Department of Dermatology and Dermatologic Surgery
  • Texas
    • Austin, Texas, United States, 78723
      • Dell Children's Medical Center
    • Corpus Christi, Texas, United States, 78411
      • Driscoll Children's Hospital
    • El Paso, Texas, United States, 79902
      • 3A Research - West Location
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Children's Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Ritlecitinib higher dose; Study intervention will be provided as oral capsules centrally by the sponsor in high-density polyethylene (HDPE) bottles.; Other Names: Active Treatment
Experimental: Ritlecitinib lower dose; Participants will receive 1 ritlecitinib lower dose capsule QD and 1 placebo higher dose capsule QD orally for 24 weeks.	Drug: Ritlecitinib lower dose; Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.; Other Names: Active Treatment
Placebo Comparator: Placebo; Participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD orally for 24 weeks.	Drug: Placebo; Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	The difference in proportions of participants with the PGI-C 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 all countries: Change from baseline (CFB) in SALT score.	The difference in means/proportions in the SALT Score at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.	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).	The difference in means/proportions in the endpoint at all scheduled time points (except for that included as the primary endpoints) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.	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).	The difference in means/proportions in the endpoint at all scheduled time points (except for that included as the primary endpoints) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.	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).	The difference in proportions of participants with the PGI-C response at all scheduled time points (except for that included as key secondary endpoint) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.	Week 2, Week 4, Week 8, Week 12, Week 18.
For all countries: Response based on improvement from baseline for each Alopecia Areata Patient Priority Outcomes (AAPPO) item.	The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.	Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: CFB in Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Depressive Symptoms T-score.	The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.	Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: CFB in PROMIS Parent Proxy Anxiety Symptoms T-score.	The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.	Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: CFB in BRIEF®2 T-scores for the 3 index scores (Behavior Regulation Index (BRI), Emotion Regulation Index (ERI), Cognitive Regulation Index (CRI)).	The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.	Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: CFB in modified Children's Dermatology Life Quality Index (CDLQI) total score.	The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.	Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: Response based on achieving at least 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score in participants with an abnormal EBA at baseline.	The difference in proportions of participants with the EBA response at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.	Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: Response based on achieving at least 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score in participants with an abnormal ELA at baseline.	The difference in proportions of participants with the ELA response at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.	Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: Plasma concentration of ritlecitinib.		Post dose hour 1 and hour 3 at day 28 or day 56.
For all countries: Incidence of treatment emergent Adverse Events (AEs).	To evaluate safety and tolerability of ritlecitinib over time.	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 8 months).
For all countries: Incidence of Serious Adverse Events (SAEs) and AEs leading to permanent discontinuation from the study.	To evaluate safety and tolerability of ritlecitinib over time.	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 8 months).
CFB in AAPPO activity limitation score.	The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.	Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: Acceptability and palatability assessment.	To evaluate acceptability and palatability of the age-appropriate formulation.	Week 2 and Week 18
CFB in AAPPO emotional symptoms score.	The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.	Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2025
• Primary Completion (Estimated): December 2, 2026
• Study Completion (Estimated): January 6, 2027

Study Registration Dates

• First Submitted: June 11, 2025
• First Submitted That Met QC Criteria: June 11, 2025
• First Posted (Actual): June 19, 2025

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Children; Alopecia areata; Ritlecitinib
• Additional Relevant MeSH Terms: Skin Diseases; Alopecia; Hypotrichosis; Hair Diseases; Skin and Connective Tissue Diseases; Alopecia Areata
• Other Study ID Numbers: B7981027; 2024-515438-33-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes