Actively Recruiting
A Phase 3 Study to Investigate the Safety and Effectiveness of Ritlecitinib in Children 6 to Less Than 12 Years With Severe Alopecia Areata
Led by Pfizer · Updated on 2026-03-30
225
Participants Needed
80
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of ritlecitinib, a medicine being studied for treating severe alopecia areata in children aged 6 to less than 12 years. Alopecia areata is a condition that causes significant hair loss on the scalp. This Phase 3 study aims to compare ritlecitinib to a placebo in pediatric participants with at least 50% scalp hair loss and prior varicella vaccination or infection, including some with a history of treatment failure in the EU/UK. Participants will be randomly assigned to one of three groups: a higher dose of ritlecitinib plus placebo, a lower dose of ritlecitinib plus placebo, or placebo only. All treatments are taken as oral capsules once daily at home for 24 weeks. This study will assess how ritlecitinib affects hair regrowth compared to placebo and will monitor safety, tolerability, and patient-centered outcomes. During the 6-month study, participants will have eight clinic visits and about eight phone calls to assess their progress. Evaluations will include scalp hair loss scores, eyebrow and eyelash assessments, patient-reported outcomes, and laboratory tests to measure drug levels and monitor safety. Those completing treatment may enter a long-term extension study or have a 4-week follow-up if they do not qualify for the extension.
CONDITIONS
Brief Title
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to less than 12 years
- Diagnosis of alopecia areata with at least 50% scalp hair loss at screening and baseline
- No evidence of hair regrowth in the past 12 months
- For EU/UK participants: history of failed alopecia areata treatment
- Documented two doses of varicella vaccination or prior varicella infection confirmed by blood test
You will not qualify if you...
- Presence of other types of alopecia besides alopecia areata
- Pre-existing hearing loss
- History or signs of cancer or lymphatic diseases such as lymphoma or leukemia
- Clinically significant depression (specific score threshold)
- Untreated or inadequately treated infections including tuberculosis, cytomegalovirus, herpes zoster, hepatitis B or C
- Vaccination with live virus vaccine within 6 weeks before starting study treatment
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.
1 visit (in-person)
Duration - 24 weeks
Participants receive oral capsules of either ritlecitinib higher dose, ritlecitinib lower dose, or placebo daily for 24 weeks to assess safety and effectiveness.
Multiple visits for assessments at Week 2, 4, 8, 12, 18, and 24
Duration - 4 weeks
Participants who complete the treatment but are not eligible for the long-term extension study undergo a 4-week off-treatment follow-up period to monitor safety.
1 visit (in-person)
Trial Site Locations
Total: 80 locations
1
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024
Actively Recruiting
2
University of California - Irvine
Irvine, California, United States, 92617
Actively Recruiting
3
Investigational Drug Service - Rady Children's Hospital-San Diego
San Diego, California, United States, 92123
Actively Recruiting
4
University of California, San Diego/Rady Children's Hospital-San Diego;
San Diego, California, United States, 92123
Actively Recruiting
5
Southern California Clinical Research
Santa Ana, California, United States, 92701
Actively Recruiting
6
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
7
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
8
Pediatric Skin Research
Miami, Florida, United States, 33156
Actively Recruiting
9
D&H Tamarac Research Center
Tamarac, Florida, United States, 33321
Actively Recruiting
10
Endeavor Health Clinical Operations
Skokie, Illinois, United States, 60077
Actively Recruiting
11
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46250
Actively Recruiting
12
Equity Medical - Bowling Green
Bowling Green, Kentucky, United States, 42104
Actively Recruiting
13
Kindred Hair and Skin Center
Marriottsville, Maryland, United States, 21104
Actively Recruiting
14
Michigan Dermatology Institute
Waterford, Michigan, United States, 48328
Actively Recruiting
15
University of Minnesota Health Clinical Research Unit (M Health CRU)
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
16
Ear, Nose and Throat Consultants, LLC
Omaha, Nebraska, United States, 68144
Actively Recruiting
17
Skin Specialists, PC dba Schlessinger MD
Omaha, Nebraska, United States, 68144
Actively Recruiting
18
Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist)
Papillion, Nebraska, United States, 68046
Actively Recruiting
19
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
20
University of New Mexico-IDS Pharmacy
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
21
Regents of the University of New Mexico
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
22
Equity Medical
New York, New York, United States, 10455
Actively Recruiting
23
Northwest Dermatology Institute
Portland, Oregon, United States, 97210
Actively Recruiting
24
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
25
Medical University of South Carolina Department of Dermatology and Dermatologic Surgery
Charleston, South Carolina, United States, 29425
Actively Recruiting
26
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Actively Recruiting
27
3A Research - West Location
El Paso, Texas, United States, 79902
Active, Not Recruiting
28
Austin Institute for Clinical Research
Pflugerville, Texas, United States, 78660
Actively Recruiting
29
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
Actively Recruiting
30
Laser Rejuvenation Clinics Edmonton D.T. Inc
Edmonton, Alberta, Canada, T5J 3S9
Actively Recruiting
31
CaRe Clinic
Red Deer, Alberta, Canada, T4P 1K4
Actively Recruiting
32
Medicine Professional Corporation
Peterborough, Ontario, Canada, K9J 5K2
Actively Recruiting
33
Research Toronto
Toronto, Ontario, Canada, M4W 2N4
Actively Recruiting
34
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
35
Beijing Children's hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100045
Actively Recruiting
36
Beijing Tongren Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
37
The Second Affiliated Hospital Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Actively Recruiting
38
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510140
Actively Recruiting
39
Hunan Children's Hospital
Changsha, Hunan, China, 410007
Actively Recruiting
40
Xiangya Hospital Central South University
Changsha, Hunan, China, 410008
Not Yet Recruiting
41
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
42
Chengdu Women and Children Center Hospital
Chengdu, Sichuan, China, 610091
Actively Recruiting
43
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Actively Recruiting
44
Kunming Children's hospital
Kunming, Yunnan, China, 650103
Not Yet Recruiting
45
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
46
Hangzhou Third Hospital
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
47
Shanghai Children's Hospital
Shanghai, China, 200062
Actively Recruiting
48
Fakultni Nemocnice Plzen
Pilsen, Czechia, 305 99
Actively Recruiting
49
Prof. MUDr. Petr Arenberger, DrSc., MBA
Prague, Czechia, 11000
Actively Recruiting
50
Fakultni nemocnice Bulovka
Prague, Czechia, 180 81
Not Yet Recruiting
51
Hospices Civils de Lyon - CIC - Hopital Louis Pradel
Bron, France, 69500
Actively Recruiting
52
Centre Hospitalier de Dijon Bourgogne - Hôpital François Mitterrand
Dijon, France, 21000
Not Yet Recruiting
53
GHICL - Service d'investigation - Recherche clinique
Lille, France, 59000
Not Yet Recruiting
54
GHICL - Hôpital Saint Vincent de Paul
Lille, France, 59020
Not Yet Recruiting
55
Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2
Nice, France, 06200
Not Yet Recruiting
56
Hopital Enfants Malades Necker
Paris, France, 75015
Not Yet Recruiting
57
Hôpitaux Drôme Nord - Romans
Romans-sur-Isère, France, 26100
Not Yet Recruiting
58
Asst Spedali Civili Di Brescia
Brescia, Italy, 25123
Not Yet Recruiting
59
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
60
Niigata University Medical & Dental Hospital
Niigata, Niigata, Japan, 951-8520
Actively Recruiting
61
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan, 431-3192
Actively Recruiting
62
Kyorin University Hospital
Mitaka, Tokyo, Japan, 181-8611
Actively Recruiting
63
Osaka Metropolitan University Hospital
Osaka, Japan, 545-8586
Actively Recruiting
64
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski s.c.
Krakow, Lesser Poland Voivodeship, Poland, 30-002
Actively Recruiting
65
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
Wroclaw, Lower Silesian Voivodeship, Poland, 50-566
Actively Recruiting
66
DERMEDIC Iwona Zdybska
Lublin, Lublin Voivodeship, Poland, 20-607
Actively Recruiting
67
Klinika Osipowicz & Turkowski
Warsaw, Masovian Voivodeship, Poland, 00-716
Actively Recruiting
68
Państwowy Instytut Medyczny MSWiA
Warsaw, Masovian Voivodeship, Poland, 02-507
Actively Recruiting
69
Provita Poliklinika
Warsaw, Masovian Voivodeship, Poland, 02-647
Actively Recruiting
70
Klinika Ambroziak Dermatologia
Warsaw, Masovian Voivodeship, Poland, 02-953
Actively Recruiting
71
Royalderm Agnieszka Nawrocka
Warsaw, Masovian Voivodeship, Poland, 02-962
Actively Recruiting
72
Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal"
Bialystok, Podlaskie Voivodeship, Poland, 15-453
Actively Recruiting
73
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, Poland, 40-611
Actively Recruiting
74
Labderm Essence Sp. Z o.o.
Ossy, Silesian Voivodeship, Poland, 42-624
Not Yet Recruiting
75
Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie
Rzeszów, Poland, 35-055
Not Yet Recruiting
76
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Łódź Voivodeship, Poland, 90-436
Actively Recruiting
77
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
78
Royal Alexandra Children's Hospital
Brighton, EAST Sussex, United Kingdom, BN2 5BE
Actively Recruiting
79
Guy's and St Thomas' NHS Foundation Trust
London, Greater London, United Kingdom, SE1 7EH
Actively Recruiting
80
Chelsea and Westminster Hospital NHS Foundation Trust
London, Greater London, United Kingdom, SW10 9NH
Actively 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
3
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