A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
BRAVE-AA-PEDS
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of Baricitinib in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
3 other identifiers
interventional
595
12 countries
127
Brief Summary
The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata (hair loss) in children from 6 years to less than 18 years of age. The study is divided into 4 periods, a 5-week Screening period, a 36-week Double-Blind Treatment Period, an approximately 2-year Long-term Extension Period, and a 4-week Post-treatment Follow-up period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2023
Longer than P75 for phase_3
127 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2023
CompletedFirst Posted
Study publicly available on registry
February 10, 2023
CompletedStudy Start
First participant enrolled
February 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2030
April 17, 2026
April 1, 2026
5 years
February 3, 2023
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20
Week 36
Secondary Outcomes (20)
Percent Change from Baseline in SALT Score
Baseline, Week 36
Percentage of Participants Achieving At Least 90% Improvement from Baseline (SALT90)
Week 36
Percentage of Participants Achieving an Absolute SALT ≤10
Week 36
Percentage of Participants with Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 Among Participants 12 Years and Older with PRO for Scalp Hair Assessment Score ≥3 at Baseline
Week 36
Mean Change from Baseline in SALT Score
Baseline, Week 36
- +15 more secondary outcomes
Study Arms (3)
Baricitinib High Dose
EXPERIMENTALParticipants will receive baricitinib high dose orally.
Baricitinib Low Dose
EXPERIMENTALParticipants will receive baricitinib low dose orally.
Placebo
PLACEBO COMPARATORParticipants will receive placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (127)
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Investigate MD
Scottsdale, Arizona, 85255, United States
California Dermatology & Clinical Research Institute
Encinitas, California, 92024, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
San Diego, California, 92123, United States
The Permanente Medical Group, Inc.
San Francisco, California, 94118, United States
Southern California Dermatology, Inc.
Santa Ana, California, 92701, United States
Dermatology Physicians of Connecticut
Fairfield, Connecticut, 06824, United States
Skin Care Research, Inc
Boca Raton, Florida, 33486, United States
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134, United States
D&H Doral Research Center LLC
Doral, Florida, 33122, United States
Skin Care Research, Inc
Hollywood, Florida, 33021, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, 32256, United States
University of Miami Miller School of Medicine
Miami, Florida, 33125, United States
Pediatric Skin Research, LLC
Miami, Florida, 33156, United States
Skin Care Physicians of Georgia
Macon, Georgia, 31217, United States
Northwestern University
Chicago, Illinois, 60611, United States
Northshore University Healthsystem
Skokie, Illinois, 60077, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
The South Bend Clinic Center for Research
South Bend, Indiana, 46617, United States
DermAssociates PC.
Rockville, Maryland, 20850, United States
Michigan Center for Research Company
Clarkston, Michigan, 48346, United States
University of Minnesota Medical School
Minneapolis, Minnesota, 55455, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506, United States
Advanced Skin Research Center
Omaha, Nebraska, 68144, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Dermatology Specialists of Charlotte
Charlotte, North Carolina, 28277, United States
OnSite Clinical Solutions
Charlotte, North Carolina, 28277, United States
Bexley Dermatology Research
Bexley, Ohio, 43209, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136, United States
Northwest Dermatology Institute
Portland, Oregon, 97210, United States
The Pennsylvania Centre for Dermatology, LLC
Exton, Pennsylvania, 19341, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
International Clinical Research - Tennessee (IC Research)
Murfreesboro, Tennessee, 37130, United States
Dermatology Treatment and Research Center
Dallas, Texas, 75230, United States
Pediatric Dermatology of North Texas
Grapevine, Texas, 76051, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
Complete Dermatology
Sugar Land, Texas, 77479, United States
University of Utah MidValley Dematology
Murray, Utah, 84107, United States
Virginia Clinical Research
Norfolk, Virginia, 23502, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53715, United States
Psoriahue Medicina Interdisciplinaria
Buenos Aires, C1425DKG, Argentina
Fundación Respirar
Buenos Aires, C1426ABP, Argentina
Derma Internacional SA
Buenos Aires, Argentina
Buenos Aires Skin
Ciudad Autonoma Buenos Aires, C1055AA0, Argentina
Instituto de Neumonología Y Dermatología
Ciudad Autonoma Buenos Aires, C1425BEA, Argentina
Hospital Universitario Austral
Pilar, 1629, Argentina
Centro Medico Privado de Reumatologia
SAN M. de Tucuman, T4000AXL, Argentina
Hospital del Niño Jesus
San Miguel de Tucumán, 4000, Argentina
Skin and Cancer Foundation Australia - Darlinghurst Clinic
Darlinghurst, 2010, Australia
Sinclair Dermatology
Melbourne, 3002, Australia
Institute for Skin, Health, and Immunity
Mitcham, 3132, Australia
Veracity Clinical Research Pty Ltd
Wooloongabba, 4102, Australia
Dermatology Research Institute
Calgary, T2J 7E1, Canada
Skin Health
Cobourg, K9A 0Z4, Canada
Lynderm Research Inc.
Markham, L3P 1X2, Canada
Dr. Chih-ho Hong Medical Inc.
Surrey, V3R 6A7, Canada
Research Toronto
Toronto, M4W 2N2, Canada
Wiseman Dermatology Research Inc.
Winnipeg, R3M 3Z4, Canada
CHRU de Brest - Hôpital Morvan
Brest, 29609, France
AP-HM CHU Timone - Pharmacie Secteur Essais Cliniques
Marseille, 13005, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, 44093, France
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, 06202, France
Centre de Sante Sabouraud
Paris, 75010, France
Hôpital Clocheville Chru-Tours Département Dermatologie
Tours, 37044, France
Fachklinik Bad Bentheim
Bad Bentheim, 48455, Germany
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin, 10117, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, 01307, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, 60590, Germany
Kath. Kinderkrankenhaus Wilhelmstift
Hamburg, 22149, Germany
Dermatologische Gemeinschaftspraxis Dres. Quist
Mainz, 55128, Germany
Klinikum Rechts der Isar der TU München
München, 80802, Germany
University of Muenster, Dept. of Dermatology, Central Study Coordination for innovative Dermatology
Münster, 48149, Germany
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
Debrecen, 4032, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Pecsi Tudomanyegyetem
Pécs, 7632, Hungary
Hamamatsu University Hospital
Hamamatsu, 431-3192, Japan
Kurume University Hospital
Kurume, 830-0011, Japan
Kyorin University Hospital
Mitaka, 181-8611, Japan
Rifu Dermatology Allergy Clinic
Miyagi-gun, 981 0112, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8520, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
Tokyo Medical University Hospital
Shinjuku-ku, 160-0023, Japan
Yamaguchi University Hospital
Ube, 755-8505, Japan
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546, Poland
CareClinic
Katowice, 40 568, Poland
Centrum Medyczne Angelius Provita
Katowice, 40-611, Poland
Gabinet Dermatologiczny
Kielce, 25-155, Poland
Specjalistyczny Gabinet Dermatologiczny s.c.
Krakow, 30 002, Poland
Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
Lodz, 90-436, Poland
Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie
Rzeszów, 35 055, Poland
DERMEDIC Jacek Zdybski
Swietokrzyski, 27 400, Poland
Provita Poliklinika Sp. z o.o.
Warsaw, 02 647, Poland
Royalderm Agnieszka Nawrocka
Warsaw, 02 962, Poland
Centralny Szpital Kliniczny MSWiA
Warsaw, 02-507, Poland
Centrum Medyczne Evimed
Warsaw, 02-625, Poland
Klinika Ambroziak Sp. Z.O.O.
Warsaw, 02-953, Poland
CityClinic Przychodnia Lekarsko-Psychologiczna
Wroclaw, 50-566, Poland
Pusan National University Hospital
Busan, 49241, South Korea
Dankook University Hospital
Cheonan-si, 31116, South Korea
Chungnam national university hospital
Daejeon, 35015, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Jeonbuk National University Hospital
Jeonju, 54907, South Korea
Kyungpook National University Hospital
Junggu, 41944, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Kyunghee University Hospital at Gangdong
Seoul, 05278, South Korea
Chung-Ang University College of Medicine - Chung-Ang University Hospital (CAUH)
Seoul, 06973, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Hospital Universitario Germans Trias i Pujol
Badalona, 08916, Spain
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitario Basurto
Bilbao (Bizkaia), 48013, Spain
Clinica Pedro Jaen
Madrid, 28006, Spain
Hospital Universitario Infanta Leonor-INTERNAL MED
Madrid, 28031, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, 333, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2023
First Posted
February 10, 2023
Study Start
February 27, 2023
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
February 1, 2030
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.