Actively Recruiting
A Long-Term, Double-Blind Extension Study to Investigate the Safety and Efficacy of Ritlecitinib in Children With Severe Alopecia Areata Who Previously Completed Studies B7981027 or B7981031
Led by Pfizer · Updated on 2026-04-28
140
Participants Needed
41
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the long-term safety and effects of ritlecitinib, an oral medicine, for children with severe alopecia areata, a condition that causes significant hair loss. This Phase 3 trial focuses on participants who completed previous Pfizer studies and have notable scalp hair loss or specific vaccination history. The study aims to understand how well ritlecitinib is tolerated and its impact on hair regrowth and quality of life over time. Participants will take ritlecitinib capsules once daily at home for up to three years. Those who previously received different doses of ritlecitinib will continue the same dose, while others will be randomly assigned to either a higher or lower dose. Dose adjustments and treatment continuation will be evaluated at specific months, with some participants switched to placebo if they do not meet efficacy criteria, though they remain in the study. During the trial, participants will attend 17 clinic visits and receive monthly phone calls. Researchers will monitor safety by tracking adverse events and assess effectiveness using tools like the Severity of Alopecia Tool (SALT), eyebrow and eyelash assessments, and patient-reported outcomes on anxiety, depression, behavior, and quality of life. The study includes ongoing safety checks and measures cognitive function at select points, ensuring thorough evaluation throughout the three-year participation period.
CONDITIONS
Brief Title
A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with alopecia areata (including alopecia totalis and alopecia universalis) who completed studies B7981027 or B7981031.
- For participants from Study B7981031: at least 50% scalp hair loss (SALT score of 50 or higher) at Screening and Baseline visits.
- Received two doses of varicella vaccine or had varicella zoster virus infection before based on blood tests.
You will not qualify if you...
- Safety events requiring permanent discontinuation during or after Study B7981027 if the last dose was within 30 days before this study.
- Participants who discontinued Study B7981027 for reasons other than safety must have resolved those issues before enrolling.
- Safety events requiring permanent discontinuation during or after Study B7981031 or if last dose of Study B7981027 was more than 30 days prior.
- Any current or past malignancies or lymphoproliferative disorders.
- Untreated or inadequately treated active or latent tuberculosis infection.
- History of severe or serious cytomegalovirus, herpes zoster, disseminated herpes simplex infections.
- Infection with hepatitis B or hepatitis C virus.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants must have completed previous studies B7981027 or B7981031 and meet specific health criteria to enroll.
Duration - Up to 3 years
Participants receive daily oral capsules of ritlecitinib at either a higher or lower dose for up to 3 years. Those who do not meet treatment continuation criteria at scheduled assessments may be switched to placebo but will remain in the study.
Visits occur at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 for assessments and treatment continuation evaluation.
Trial Site Locations
Total: 41 locations
1
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024
Actively Recruiting
2
Pediatric Skin Research
Miami, Florida, United States, 33156
Actively Recruiting
3
D&H Tamarac Research Center
Tamarac, Florida, United States, 33321
Not Yet Recruiting
4
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46250
Actively Recruiting
5
Kindred Hair and Skin Center
Marriottsville, Maryland, United States, 21104
Not Yet Recruiting
6
Michigan Dermatology Institute
Waterford, Michigan, United States, 48328
Not Yet Recruiting
7
Ear, Nose & Throat Consultants, LLC
Omaha, Nebraska, United States, 68144
Actively Recruiting
8
Skin Specialists, PC dba Schlessinger MD
Omaha, Nebraska, United States, 68144
Actively Recruiting
9
Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist)
Papillion, Nebraska, United States, 68046
Actively Recruiting
10
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
11
University of New Mexico-IDS Pharmacy
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
12
Regents of the University of New Mexico
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
13
Equity Medical, LLC
The Bronx, New York, United States, 10455
Not Yet Recruiting
14
Northwest Dermatology Institute
Portland, Oregon, United States, 97210
Actively Recruiting
15
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Not Yet Recruiting
16
Medical University of South Carolina Department of Dermatology and Dermatologic Surgery
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
17
3A Research
El Paso, Texas, United States, 79902
Actively Recruiting
18
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
Actively Recruiting
19
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
20
Prof. MUDr. Petr Arenberger, DrSc., MBA
Prague, Czechia, 11000
Not Yet Recruiting
21
Hospices Civils de Lyon - Hopital Femme Mere Enfant
Bron, France, 69500
Not Yet Recruiting
22
CHU de Dijon Bourgogne
Dijon, France, 21079
Not Yet Recruiting
23
GHICL - Service d'investigation - Recherche clinique
Lille, France, 59000
Not Yet Recruiting
24
Hôpital Saint Vincent de Paul
Lille, France, 59020
Not Yet Recruiting
25
Centre Hospitalier Universitaire de Nice
Nice, France, 06202
Not Yet Recruiting
26
Hôpitaux Drôme Nord
Romans-sur-Isère, France, 26100
Not Yet Recruiting
27
Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey
Toulouse, France, 31400
Not Yet Recruiting
28
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Not Yet Recruiting
29
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan, 431-3192
Actively Recruiting
30
Kyorin University Hospital
Mitaka, Tokyo, Japan, 181-8611
Not Yet Recruiting
31
Osaka Metropolitan University Hospital
Osaka, Japan, 545-8586
Actively Recruiting
32
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
Wroclaw, Lower Silesian Voivodeship, Poland, 50-566
Not Yet Recruiting
33
DERMEDIC Iwona Zdybska
Lublin, Lublin Voivodeship, Poland, 20-607
Not Yet Recruiting
34
Klinika Osipowicz & Turkowski
Warsaw, Masovian Voivodeship, Poland, 00-716
Not Yet Recruiting
35
Państwowy Instytut Medyczny MSWiA
Warsaw, Masovian Voivodeship, Poland, 02-507
Not Yet Recruiting
36
Provita Poliklinika
Warsaw, Masovian Voivodeship, Poland, 02-647
Not Yet Recruiting
37
Klinika Ambroziak Dermatologia
Warsaw, Masovian Voivodeship, Poland, 02-953
Not Yet Recruiting
38
Royalderm Agnieszka Nawrocka
Warsaw, Masovian Voivodeship, Poland, 02-962
Not Yet Recruiting
39
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, Poland, 40-611
Not Yet Recruiting
40
Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie
Rzeszów, Poland, 35-055
Not Yet Recruiting
41
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Łódź Voivodeship, Poland, 90-436
Not Yet Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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