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New pill could help kids with severe hair loss regrow hair

NCT ID NCT07029711

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

208 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

6 to 11 years

Sex

Anyone

Healthy volunteers

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

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

  • 3A Research - West Location

    El Paso, Texas, 79902, United States

  • Asst Spedali Civili Di Brescia

    Brescia, 25123, Italy

  • Austin Institute for Clinical Research

    Pflugerville, Texas, 78660, United States

  • Beijing Children's hospital, Capital Medical University

    Beijing, Beijing Municipality, 100045, China

  • Beijing Tongren Hospital affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100730, China

  • CHU de Dijon Bourgogne

    Dijon, 21079, France

  • Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2

    Nice, 06200, France

  • Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey

    Toulouse, 31400, France

  • Centrum Medyczne Angelius Provita

    Katowice, Silesian Voivodeship, 40-611, Poland

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London, Greater London, SW10 9NH, United Kingdom

  • Chengdu Women and Children Center Hospital

    Chengdu, Sichuan, 610091, China

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • Children's Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100192, China

  • China-Japan Friendship Hospital

    Beijing, 100029, China

  • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

    Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

  • Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist)

    Papillion, Nebraska, 68046, United States

  • DERMEDIC Iwona Zdybska

    Lublin, Lublin Voivodeship, 20-607, Poland

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250, United States

  • Dell Children's Medical Center

    Austin, Texas, 78723, United States

  • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak

    Lodz, Łódź Voivodeship, 90-436, Poland

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411, United States

  • Ear, Nose and Throat Consultants, LLC

    Omaha, Nebraska, 68144, United States

  • Endeavor Health Audiology -CHICAGO

    Chicago, Illinois, 60625, United States

  • Endeavor Health Audiology -LAKE BLUFF

    Lake Bluff, Illinois, 60044, United States

  • Endeavor Health Audiology-NORTHBROOK

    Northbrook, Illinois, 60062, United States

  • Endeavor Health Audiology-SKOKIE

    Skokie, Illinois, 60076, United States

  • Endeavor Health Behavioral Health - Evanston

    Evanston, Illinois, 60201, United States

  • Endeavor Health Clinical Operations

    Evanston, Illinois, 60201, United States

  • Endeavor Health Clinical Operations

    Skokie, Illinois, 60077, United States

  • Endeavor Health Lab Services - Old Orchard

    Skokie, Illinois, 60077, United States

  • Fakultní Nemocnice Brno

    Brno, 613 00, Czechia

  • Fakultní nemocnice Bulovka

    Praha 8 - Libeň, 180 81, Czechia

  • Fakultní nemocnice Plzeň

    Pilsen, 30599, Czechia

  • GHICL - Hôpital Saint Vincent de Paul

    Lille, 59020, France

  • GHICL - Service d'investigation - Recherche clinique

    Lille, 59000, France

  • Guy's and St Thomas' NHS Foundation Trust

    London, Greater London, SE1 7EH, United Kingdom

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192, Japan

  • Hangzhou Third Hospital

    Hangzhou, Zhejiang, 310009, China

  • Hospices Civils de Lyon - CIC - Hopital Louis Pradel

    Bron, 69500, France

  • Hospices Civils de Lyon - Hopital Femme Mere Enfant

    Bron, 69500, France

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025, Spain

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040, China

  • Hunan Children's Hospital

    Changsha, Hunan, 410007, China

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138, Italy

  • Kindred Hair and Skin Center

    Marriottsville, Maryland, 21104, United States

  • Klinika Ambroziak Dermatologia

    Warsaw, Masovian Voivodeship, 02-953, Poland

  • Klinika Osipowicz & Turkowski

    Warsaw, Masovian Voivodeship, 00-716, Poland

  • Kunming Children's hospital

    Kunming, Yunnan, 650103, China

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8611, Japan

  • Labderm Essence Sp. Z o.o.

    Ossy, Silesian Voivodeship, 42-624, Poland

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina Department of Dermatology and Dermatologic Surgery

    Charleston, South Carolina, 29425, United States

  • Michigan Dermatology Institute

    Waterford, Michigan, 48328, United States

  • Niigata University Medical & Dental Hospital

    Niigata, Niigata, 951-8520, Japan

  • Northwest Dermatology Institute

    Portland, Oregon, 97210, United States

  • Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal"

    Bialystok, Podlaskie Voivodeship, 15-453, Poland

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586, Japan

  • Państwowy Instytut Medyczny MSWiA

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • Pediatric Skin Research

    Miami, Florida, 33156, United States

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Policlinico "G. Rodolico

    Catania, 95123, Italy

  • Prof. MUDr. Petr Arenberger, DrSc., MBA

    Prague, 11000, Czechia

  • Provita Poliklinika

    Warsaw, Masovian Voivodeship, 02-647, Poland

  • Provita Sp. z o.o.

    Katowice, Silesian Voivodeship, 40-611, Poland

  • Royal Alexandra Children's Hospital

    Brighton, EAST Sussex, BN2 5BE, United Kingdom

  • Royalderm Agnieszka Nawrocka

    Warsaw, Masovian Voivodeship, 02-962, Poland

  • Shanghai Children's Hospital

    Shanghai, 200062, China

  • Skin Specialists, PC dba Schlessinger MD

    Omaha, Nebraska, 68144, United States

  • Southern California Clinical Research

    Santa Ana, California, 92701, United States

  • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski s.c.

    Krakow, Lesser Poland Voivodeship, 30-002, Poland

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218, United States

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510140, China

  • The First People's Hospital of Hangzhou

    Hangzhou, Zhejiang, 310006, China

  • The Second Affiliated Hospital Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010, China

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • UCI Dermatology Clinical Research

    Irvine, California, 92697, United States

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87102, United States

  • University of New Mexico-IDS Pharmacy

    Albuquerque, New Mexico, 87106, United States

  • Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie

    Rzeszów, 35-055, Poland

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.