New pill could help kids with severe hair loss regrow hair
NCT ID NCT07029711
First seen Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 3 times
Summary
This study tests a daily oral medication called ritlecitinib in children aged 6 to 12 with severe alopecia areata, a condition causing significant hair loss. About 208 children will receive either a higher dose, lower dose, or placebo for 6 months. The goal is to see if the drug can safely regrow scalp hair.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ritlecitinib (oral capsule)
- What this could lead to
- If it works, this could offer a new treatment option for children with severe alopecia areata, helping regrow scalp hair.
- What could go wrong
- This is a Phase 3 trial, but results are not yet known. The drug may not work better than placebo, and side effects are possible. It is not a cure—treatment may need to continue.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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208 people
The number who actually took part.
- Started
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Jul 2025
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 11 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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3A Research - West Location
El Paso, Texas, 79902, United States
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Asst Spedali Civili Di Brescia
Brescia, 25123, Italy
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Austin Institute for Clinical Research
Pflugerville, Texas, 78660, United States
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Beijing Children's hospital, Capital Medical University
Beijing, Beijing Municipality, 100045, China
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Beijing Tongren Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100730, China
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CHU de Dijon Bourgogne
Dijon, 21079, France
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Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2
Nice, 06200, France
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Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey
Toulouse, 31400, France
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Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, 40-611, Poland
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Chelsea and Westminster Hospital NHS Foundation Trust
London, Greater London, SW10 9NH, United Kingdom
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Chengdu Women and Children Center Hospital
Chengdu, Sichuan, 610091, China
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Children's Hospital Colorado
Aurora, Colorado, 80045, United States
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Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
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Children's Wisconsin
Milwaukee, Wisconsin, 53226, United States
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100192, China
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China-Japan Friendship Hospital
Beijing, 100029, China
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Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
Wroclaw, Lower Silesian Voivodeship, 50-566, Poland
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Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist)
Papillion, Nebraska, 68046, United States
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DERMEDIC Iwona Zdybska
Lublin, Lublin Voivodeship, 20-607, Poland
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Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
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Dell Children's Medical Center
Austin, Texas, 78723, United States
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Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Łódź Voivodeship, 90-436, Poland
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Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
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Ear, Nose and Throat Consultants, LLC
Omaha, Nebraska, 68144, United States
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Endeavor Health Audiology -CHICAGO
Chicago, Illinois, 60625, United States
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Endeavor Health Audiology -LAKE BLUFF
Lake Bluff, Illinois, 60044, United States
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Endeavor Health Audiology-NORTHBROOK
Northbrook, Illinois, 60062, United States
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Endeavor Health Audiology-SKOKIE
Skokie, Illinois, 60076, United States
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Endeavor Health Behavioral Health - Evanston
Evanston, Illinois, 60201, United States
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Endeavor Health Clinical Operations
Evanston, Illinois, 60201, United States
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Endeavor Health Clinical Operations
Skokie, Illinois, 60077, United States
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Endeavor Health Lab Services - Old Orchard
Skokie, Illinois, 60077, United States
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Fakultní Nemocnice Brno
Brno, 613 00, Czechia
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Fakultní nemocnice Bulovka
Praha 8 - Libeň, 180 81, Czechia
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Fakultní nemocnice Plzeň
Pilsen, 30599, Czechia
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GHICL - Hôpital Saint Vincent de Paul
Lille, 59020, France
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GHICL - Service d'investigation - Recherche clinique
Lille, 59000, France
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Guy's and St Thomas' NHS Foundation Trust
London, Greater London, SE1 7EH, United Kingdom
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Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
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Hangzhou Third Hospital
Hangzhou, Zhejiang, 310009, China
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Hospices Civils de Lyon - CIC - Hopital Louis Pradel
Bron, 69500, France
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Hospices Civils de Lyon - Hopital Femme Mere Enfant
Bron, 69500, France
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Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
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Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
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Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
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Hunan Children's Hospital
Changsha, Hunan, 410007, China
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
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Kindred Hair and Skin Center
Marriottsville, Maryland, 21104, United States
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Klinika Ambroziak Dermatologia
Warsaw, Masovian Voivodeship, 02-953, Poland
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Klinika Osipowicz & Turkowski
Warsaw, Masovian Voivodeship, 00-716, Poland
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Kunming Children's hospital
Kunming, Yunnan, 650103, China
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Kyorin University Hospital
Mitaka, Tokyo, 181-8611, Japan
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Labderm Essence Sp. Z o.o.
Ossy, Silesian Voivodeship, 42-624, Poland
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Medical University of South Carolina Department of Dermatology and Dermatologic Surgery
Charleston, South Carolina, 29425, United States
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Michigan Dermatology Institute
Waterford, Michigan, 48328, United States
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Niigata University Medical & Dental Hospital
Niigata, Niigata, 951-8520, Japan
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Northwest Dermatology Institute
Portland, Oregon, 97210, United States
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Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal"
Bialystok, Podlaskie Voivodeship, 15-453, Poland
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Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
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Państwowy Instytut Medyczny MSWiA
Warsaw, Masovian Voivodeship, 02-507, Poland
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Pediatric Skin Research
Miami, Florida, 33156, United States
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Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
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Policlinico "G. Rodolico
Catania, 95123, Italy
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Prof. MUDr. Petr Arenberger, DrSc., MBA
Prague, 11000, Czechia
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Provita Poliklinika
Warsaw, Masovian Voivodeship, 02-647, Poland
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Provita Sp. z o.o.
Katowice, Silesian Voivodeship, 40-611, Poland
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Royal Alexandra Children's Hospital
Brighton, EAST Sussex, BN2 5BE, United Kingdom
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Royalderm Agnieszka Nawrocka
Warsaw, Masovian Voivodeship, 02-962, Poland
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Shanghai Children's Hospital
Shanghai, 200062, China
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Skin Specialists, PC dba Schlessinger MD
Omaha, Nebraska, 68144, United States
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Southern California Clinical Research
Santa Ana, California, 92701, United States
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Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski s.c.
Krakow, Lesser Poland Voivodeship, 30-002, Poland
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Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
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The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510140, China
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The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310006, China
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The Second Affiliated Hospital Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
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Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
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UCI Dermatology Clinical Research
Irvine, California, 92697, United States
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University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87102, United States
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University of New Mexico-IDS Pharmacy
Albuquerque, New Mexico, 87106, United States
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Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie
Rzeszów, 35-055, Poland
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Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a JAK inhibitor bring back hair in kids with severe alopecia?
- New pill could regrow hair in severe alopecia – trial begins
- New antibody drug aims to halt skin and hair loss
- New drug litfulo tracked in 3,000 patients for hair loss treatment
- New analysis explores how patients and doctors view ritlecitinib for severe hair loss
- Hair loss drug ritlecitinib tested for Long-Term safety in teens