New hope for kids with severe hair loss: baricitinib pill tested in major trial

NCT ID NCT05723198

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This study tests whether baricitinib, a daily pill, can safely regrow hair in children aged 6 to 17 with severe alopecia areata (patchy hair loss). About 595 kids will receive either the drug or a placebo for 36 weeks, then all can get the drug for up to 2 years. The goal is to see if at least 80% of scalp hair returns.

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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

About 595 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Sep 2033

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 17 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: * Enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years old). * Have severe areata alopecia (AA) for at least 1 year * Diagnosis for at least 1 year * Current AA episode of at least 6 months' duration * SALT score ≥50% at screening and baseline * History of trial and failure with at least 1 available treatment (topical or other) for AA * History of psychological counseling related to AA * Current episode of severe AA of less than 8 years. * Note: Participants who have severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years. Exclusion Criteria: * Primarily "diffuse" type of AA (characterized by diffuse hair shedding). * Are currently experiencing other forms of alopecia including, but not limited to trichotillomania, telogen effluvium, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis) that would interfere with evaluations of the effect of study medication on AA. * Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden * Have uncontrolled arterial hypertension * Have had major surgery within 8 weeks prior to screening or will require major surgery during the study * Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking IP or interfere with the interpretation of data. * Have a positive test for hepatitis B virus (HBV) infection * Have hepatitis C virus (HCV) infection (positive for anti hepatitis C antibody with confirmed presence of HCV ribonucleic acid \[RNA\]). * Have evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.

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Conditions

The condition(s) this trial relates to.

alopecia alopecia areata disorder of pilosebaceous unit hypotrichosis Pathological Conditions, Anatomical skin disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alopecia Areata alopecia Hair diseases Hypotrichosis Pathological conditions, anatomical Skin diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

119 sites in 12 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AP-HM CHU Timone - Pharmacie Secteur Essais Cliniques
RECRUITING

Marseille, 13005, France
Advanced Skin Research Center
RECRUITING

Omaha, Nebraska, 68144, United States
Ajou University Hospital
RECRUITING

Suwon, 16499, South Korea
Bexley Dermatology Research
RECRUITING

Bexley, Ohio, 43209, United States
Buenos Aires Skin
RECRUITING

Ciudad Autonoma Buenos Aires, C1055AA0, Argentina
CHRU de Brest - Hôpital Morvan
NOT_YET_RECRUITING

Brest, 29609, France
California Dermatology & Clinical Research Institute
NOT_YET_RECRUITING

Encinitas, California, 92024, United States
CareClinic
RECRUITING

Katowice, 40 568, Poland
Centralny Szpital Kliniczny MSWiA
RECRUITING

Warsaw, 02-507, Poland
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
RECRUITING

Nantes, 44093, France
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
RECRUITING

Nice, 06202, France
Centre de Sante Sabouraud
RECRUITING

Paris, 75010, France
Centro Medico Privado de Reumatologia
COMPLETED

SAN M. de Tucuman, T4000AXL, Argentina
Centrum Badan Klinicznych PI-House sp. z o.o.
RECRUITING

Gdansk, 80-546, Poland
Centrum Medyczne Angelius Provita
RECRUITING

Katowice, 40-611, Poland
Centrum Medyczne Evimed
RECRUITING

Warsaw, 02-625, Poland
Chang Gung Medical Foundation-Linkou Branch
NOT_YET_RECRUITING

Taoyuan, 333, Taiwan
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
RECRUITING

Berlin, 10117, Germany
Chung Shan Medical University Hospital
RECRUITING

Taichung, 40201, Taiwan
Chung-Ang University College of Medicine - Chung-Ang University Hospital (CAUH)
RECRUITING

Seoul, 06973, South Korea
Chungnam national university hospital
RECRUITING

Daejeon, 35015, South Korea
Cincinnati Childrens Hospital Medical Center
NOT_YET_RECRUITING

Cincinnati, Ohio, 45229, United States
CityClinic Przychodnia Lekarsko-Psychologiczna
RECRUITING

Wroclaw, 50-566, Poland
Clinica Pedro Jaen
COMPLETED

Madrid, 28006, Spain
Complete Dermatology
RECRUITING

Sugar Land, Texas, 77479, United States
D&H Doral Research Center LLC
NOT_YET_RECRUITING

Doral, Florida, 33122, United States
DERMEDIC Jacek Zdybski
RECRUITING

Swietokrzyski, 27 400, Poland
Dankook University Hospital
RECRUITING

Cheonan-si, 31116, South Korea
Dawes Fretzin Clinical Research Group, LLC
RECRUITING

Indianapolis, Indiana, 46250, United States
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
COMPLETED

Debrecen, 4032, Hungary
DermAssociates PC.
RECRUITING

Rockville, Maryland, 20850, United States
Derma Internacional SA
RECRUITING

Buenos Aires, Argentina
Dermatologische Gemeinschaftspraxis Dres. Quist
RECRUITING

Mainz, 55128, Germany
Dermatology Physicians of Connecticut
NOT_YET_RECRUITING

Fairfield, Connecticut, 06824, United States
Dermatology Research Associates
RECRUITING

Los Angeles, California, 90045, United States
Dermatology Research Institute
RECRUITING

Calgary, T2J 7E1, Canada
Dermatology Specialists of Charlotte
RECRUITING

Charlotte, North Carolina, 28277, United States
Dermatology Treatment and Research Center
NOT_YET_RECRUITING

Dallas, Texas, 75230, United States
Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
RECRUITING

Lodz, 90-436, Poland
Dr. Chih-ho Hong Medical Inc.
RECRUITING

Surrey, V3R 6A7, Canada
Fachklinik Bad Bentheim
RECRUITING

Bad Bentheim, 48455, Germany
Florida Academic Centers Research and Education, LLC
COMPLETED

Coral Gables, Florida, 33134, United States
Fundación Respirar
RECRUITING

Buenos Aires, C1426ABP, Argentina
Gabinet Dermatologiczny
RECRUITING

Kielce, 25-155, Poland
Hamamatsu University Hospital
RECRUITING

Hamamatsu, 431-3192, Japan
Hospital General Universitario de Valencia
RECRUITING

Valencia, 46014, Spain
Hospital Universitario Austral
NOT_YET_RECRUITING

Pilar, 1629, Argentina
Hospital Universitario Basurto
COMPLETED

Bilbao (Bizkaia), 48013, Spain
Hospital Universitario Germans Trias i Pujol
RECRUITING

Badalona, 08916, Spain
Hospital Universitario Infanta Leonor-INTERNAL MED
RECRUITING

Madrid, 28031, Spain
Hospital del Niño Jesus
RECRUITING

San Miguel de Tucumán, 4000, Argentina
Hôpital Clocheville Chru-Tours Département Dermatologie
RECRUITING

Tours, 37044, France
Inha University Hospital
RECRUITING

Incheon, 22332, South Korea
Institute for Skin, Health, and Immunity
RECRUITING

Mitcham, 3132, Australia
Instituto de Neumonología Y Dermatología
RECRUITING

Ciudad Autonoma Buenos Aires, C1425BEA, Argentina
International Clinical Research - Tennessee (IC Research)
RECRUITING

Murfreesboro, Tennessee, 37130, United States
Investigate MD
RECRUITING

Scottsdale, Arizona, 85255, United States
Jeonbuk National University Hospital
RECRUITING

Jeonju, 54907, South Korea
Kath. Kinderkrankenhaus Wilhelmstift
RECRUITING

Hamburg, 22149, Germany
Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie
RECRUITING

Rzeszów, 35 055, Poland
Klinika Ambroziak Sp. Z.O.O.
RECRUITING

Warsaw, 02-953, Poland
Klinikum Rechts der Isar der TU München
NOT_YET_RECRUITING

München, 80802, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
RECRUITING

Frankfurt am Main, 60590, Germany
Konkuk University Medical Center
RECRUITING

Seoul, 05030, South Korea
Kurume University Hospital
RECRUITING

Kurume, 830-0011, Japan
Kyorin University Hospital
RECRUITING

Mitaka, 181-8611, Japan
Kyunghee University Hospital at Gangdong
RECRUITING

Seoul, 05278, South Korea
Kyungpook National University Hospital
RECRUITING

Junggu, 41944, South Korea
Lynderm Research Inc.
RECRUITING

Markham, L3P 1X2, Canada
MediSearch Clinical Trials
RECRUITING

Saint Joseph, Missouri, 64506, United States
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29425, United States
Michigan Center for Research Company
RECRUITING

Clarkston, Michigan, 48346, United States
Montefiore Medical Center
RECRUITING

The Bronx, New York, 10467, United States
National Cheng Kung University Hospital
NOT_YET_RECRUITING

Tainan, 70403, Taiwan
National Taiwan University Hospital
RECRUITING

Taipei, 100, Taiwan
Niigata University Medical & Dental Hospital
RECRUITING

Niigata, 951-8520, Japan
Northshore University Healthsystem
RECRUITING

Skokie, Illinois, 60077, United States
Northwest Dermatology Institute
RECRUITING

Portland, Oregon, 97210, United States
Northwestern University
NOT_YET_RECRUITING

Chicago, Illinois, 60611, United States
OnSite Clinical Solutions
COMPLETED

Charlotte, North Carolina, 28277, United States
Osaka City University Hospital
RECRUITING

Osaka, 545-8586, Japan
Parc de Salut Mar - Hospital del Mar
RECRUITING

Barcelona, 08003, Spain
Pecsi Tudomanyegyetem
RECRUITING

Pécs, 7632, Hungary
Pediatric Dermatology of North Texas
RECRUITING

Grapevine, Texas, 76051, United States
Pediatric Skin Research, LLC
RECRUITING

Miami, Florida, 33156, United States
Provita Poliklinika Sp. z o.o.
RECRUITING

Warsaw, 02 647, Poland
Psoriahue Medicina Interdisciplinaria
RECRUITING

Buenos Aires, C1425DKG, Argentina
Pusan National University Hospital
RECRUITING

Busan, 49241, South Korea
Research Toronto
RECRUITING

Toronto, M4W 2N2, Canada
Rifu Dermatology Allergy Clinic
RECRUITING

Miyagi-gun, 981 0112, Japan
Royalderm Agnieszka Nawrocka
RECRUITING

Warsaw, 02 962, Poland
Seoul National University Bundang Hospital
RECRUITING

Seongnam-si, 13620, South Korea
Seoul National University Hospital
RECRUITING

Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
RECRUITING

Seoul, 03722, South Korea
Sinclair Dermatology
RECRUITING

Melbourne, 3002, Australia
Skin Care Physicians of Georgia
RECRUITING

Macon, Georgia, 31217, United States
Skin Care Research, Inc
NOT_YET_RECRUITING

Boca Raton, Florida, 33486, United States
Skin Care Research, Inc
NOT_YET_RECRUITING

Hollywood, Florida, 33021, United States
Skin Health
RECRUITING

Cobourg, K9A 0Z4, Canada
Skin and Cancer Foundation Australia - Darlinghurst Clinic
COMPLETED

Darlinghurst, 2010, Australia
Solutions Through Advanced Research, Inc.
RECRUITING

Jacksonville, Florida, 32256, United States
Somogy Megyei Kaposi Mor Oktato Korhaz
NOT_YET_RECRUITING

Kaposvár, 7400, Hungary
Southern California Dermatology, Inc.
RECRUITING

Santa Ana, California, 92701, United States
Specjalistyczny Gabinet Dermatologiczny s.c.
RECRUITING

Krakow, 30 002, Poland
Taipei Medical University Shuang Ho Hospital
NOT_YET_RECRUITING

New Taipei City, 235, Taiwan
Taipei Veterans General Hospital
NOT_YET_RECRUITING

Taipei, 11217, Taiwan
Texas Dermatology and Laser Specialists
RECRUITING

San Antonio, Texas, 78218, United States
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
RECRUITING

Seoul, 03312, South Korea
The Pennsylvania Centre for Dermatology, LLC
COMPLETED

Exton, Pennsylvania, 19341, United States
The Permanente Medical Group, Inc.
RECRUITING

San Francisco, California, 94118, United States
The South Bend Clinic Center for Research
RECRUITING

South Bend, Indiana, 46617, United States
Tokyo Medical University Hospital
RECRUITING

Shinjuku-ku, 160-0023, Japan
Total Skin and Beauty Dermatology Center, PC
RECRUITING

Birmingham, Alabama, 35205, United States
University Hospitals Cleveland Medical Center
NOT_YET_RECRUITING

Cleveland, Ohio, 44106, United States
University of Alabama at Birmingham
NOT_YET_RECRUITING

Birmingham, Alabama, 35233, United States
University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
RECRUITING

San Diego, California, 92123, United States
University of Miami Miller School of Medicine
NOT_YET_RECRUITING

Miami, Florida, 33125, United States
University of Minnesota Medical School
RECRUITING

Minneapolis, Minnesota, 55455, United States
University of Muenster, Dept. of Dermatology, Central Study Coordination for innovative Dermatology
RECRUITING

Münster, 48149, Germany
University of Utah MidValley Dematology
NOT_YET_RECRUITING

Murray, Utah, 84107, United States
University of Wisconsin-Madison
RECRUITING

Madison, Wisconsin, 53715, United States
Universitätsklinikum Carl Gustav Carus
RECRUITING

Dresden, 01307, Germany
Veracity Clinical Research Pty Ltd
RECRUITING

Wooloongabba, 4102, Australia
Virginia Clinical Research
RECRUITING

Norfolk, Virginia, 23502, United States
Vital Prospects Clinical Research Institute, P.C.
RECRUITING

Tulsa, Oklahoma, 74136, United States
Wiseman Dermatology Research Inc.
RECRUITING

Winnipeg, R3M 3Z4, Canada
Yamaguchi University Hospital
RECRUITING

Ube, 755-8505, Japan

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