A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata (BRAVE-AA-PEDS)

May 18, 2026 updated by: Eli Lilly and Company

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

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 (LTE) Period, and a 4-week Post-treatment Follow-up period. Some individuals may be eligible to receive treatment after completing the LTE, for a maximum of 180 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
595

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Recruiting
        • Fundación Respirar
        • Contact:
          • Phone Number: +5403814200180
        • Principal Investigator:
          • Maria Fernandez
      • Buenos Aires, Argentina, C1425DKG
        • Recruiting
        • Psoriahue Medicina Interdisciplinaria
        • Principal Investigator:
          • Gabriel Alejandro Magarinos
        • Contact:
          • Phone Number: +5491150461624
      • Buenos Aires, Argentina
        • Recruiting
        • Derma Internacional SA
        • Contact:
          • Phone Number: 5491139842833
        • Principal Investigator:
          • Maria Galimberti
      • Ciudad Autonoma Buenos Aires, Argentina, C1055AA0
        • Recruiting
        • Buenos Aires Skin
        • Principal Investigator:
          • Matias Turienzo
        • Contact:
          • Phone Number: +541152190541
      • Ciudad Autonoma Buenos Aires, Argentina, C1425BEA
        • Recruiting
        • Instituto de Neumonologia y Dermatologia
        • Contact:
          • Phone Number: 5491145404544
        • Principal Investigator:
          • Paula Luna
      • Pilar, Argentina, 1629
        • Not yet recruiting
        • Hospital Universitario Austral
        • Contact:
          • Phone Number: +541127690233
        • Principal Investigator:
          • Carla Castro
      • SAN M. de Tucuman, Argentina, T4000AXL
        • Completed
        • Centro Medico Privado de Reumatologia
      • San Miguel de Tucumán, Argentina, 4000
        • Recruiting
        • Hospital del Niño Jesús
        • Contact:
          • Phone Number: +5493815863707
        • Principal Investigator:
          • Maria Fiandrino
  • Australia
      • Darlinghurst, Australia, 2010
        • Completed
        • Skin and Cancer Foundation Australia - Darlinghurst Clinic
      • Melbourne, Australia, 3002
        • Recruiting
        • Sinclair Dermatology
        • Contact:
          • Phone Number: 3 9013 0099
        • Principal Investigator:
          • Samantha Eisman
      • Mitcham, Australia, 3132
        • Recruiting
        • Institute for Skin, Health, and Immunity
        • Contact:
          • Phone Number: 412476267
        • Principal Investigator:
          • John Su
      • Wooloongabba, Australia, 4102
        • Recruiting
        • Veracity Clinical Research Pty Ltd
        • Principal Investigator:
          • Lynda Spelman
        • Contact:
          • Phone Number: 730391346
  • Canada
      • Calgary, Canada, T2J 7E1
        • Recruiting
        • Dermatology Research Institute
        • Contact:
          • Phone Number: 4032633376
        • Principal Investigator:
          • Vimal Prajapati
      • Cobourg, Canada, K9A 0Z4
        • Recruiting
        • Skin Health
        • Principal Investigator:
          • Melinda Gooderham
        • Contact:
          • Phone Number: (289) 252-1856
      • Markham, Canada, L3P 1X2
        • Recruiting
        • Lynderm Research Inc.
        • Principal Investigator:
          • Charles Lynde
        • Contact:
          • Phone Number: 905-471-8011
      • Surrey, Canada, V3R 6A7
        • Recruiting
        • Dr. Chih-Ho Hong Medical Inc.
        • Contact:
          • Phone Number: 604-953-1333
        • Principal Investigator:
          • Gurbir Dhadwal
      • Toronto, Canada, M4W 2N2
        • Recruiting
        • Research Toronto
        • Principal Investigator:
          • Sameh Hanna
        • Contact:
          • Phone Number: 416-962-0123
      • Winnipeg, Canada, R3M 3Z4
        • Recruiting
        • Wiseman Dermatology Research Inc.
        • Principal Investigator:
          • Marni Wiseman
        • Contact:
          • Phone Number: 204-943-4922
  • France
      • Brest, France, 29609
        • Not yet recruiting
        • CHRU de Brest - Hopital Morvan
        • Contact:
          • Phone Number: 298223333
        • Principal Investigator:
          • Claire Abasq
      • Marseille, France, 13005
        • Recruiting
        • AP-HM CHU Timone - Pharmacie Secteur Essais Cliniques
        • Principal Investigator:
          • Stephanie Mallet
        • Contact:
          • Phone Number: 0491384930
      • Nantes, France, 44093
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
        • Principal Investigator:
          • Sebastien Barbarot
        • Contact:
          • Phone Number: 02 40 08 48 86 (84 886)
      • Nice, France, 06202
        • Recruiting
        • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
        • Contact:
          • Phone Number: 492036667
        • Principal Investigator:
          • Thierry Passeron
      • Paris, France, 75010
        • Recruiting
        • Centre de Sante Sabouraud
        • Principal Investigator:
          • Pascal Reygagne
        • Contact:
          • Phone Number: +33761453540
      • Tours, France, 37044
        • Recruiting
        • Hôpital Clocheville Chru-Tours Département Dermatologie
        • Principal Investigator:
          • Annabel Maruani
        • Contact:
          • Phone Number: 33247474625
  • Germany
      • Bad Bentheim, Germany, 48455
        • Recruiting
        • Fachklinik Bad Bentheim
        • Principal Investigator:
          • Athanasios Tsianakas
        • Contact:
          • Phone Number: 5922745210
      • Berlin, Germany, 10117
        • Recruiting
        • Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
        • Principal Investigator:
          • Ulrike Blume-Peytavi
        • Contact:
          • Phone Number: 30450518122
      • Dresden, Germany, 01307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus
        • Contact:
          • Phone Number: 3514582007
        • Principal Investigator:
          • Roland Aschoff
      • Frankfurt am Main, Germany, 60590
        • Recruiting
        • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
        • Principal Investigator:
          • Andreas Pinter
        • Contact:
          • Phone Number: 004969630183115
      • Hamburg, Germany, 22149
        • Recruiting
        • Kath. Kinderkrankenhaus Wilhelmstift
        • Principal Investigator:
          • Peter Hoeger
      • Mainz, Germany, 55128
        • Recruiting
        • Dermatologische Gemeinschaftspraxis Dres. Quist
        • Contact:
          • Phone Number: +49 34196280027
        • Principal Investigator:
          • Sven Quist
      • München, Germany, 80802
        • Not yet recruiting
        • Klinikum rechts der Isar der TU München
        • Contact:
          • Phone Number: 0049-4140-3231
        • Principal Investigator:
          • Christina Schnopp
      • Münster, Germany, 48149
        • Recruiting
        • University of Muenster, Dept. of Dermatology, Central Study Coordination for innovative Dermatology
        • Principal Investigator:
          • Nina Magnolo
        • Contact:
          • Phone Number: 2518357296
  • Hungary
      • Debrecen, Hungary, 4032
        • Completed
        • Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
      • Kaposvár, Hungary, 7400
        • Not yet recruiting
        • Somogy Megyei Kaposi Mor Oktato Korhaz
        • Contact:
          • Phone Number: +36 30 3005085
        • Principal Investigator:
          • Beata Fabos
      • Pécs, Hungary, 7632
        • Recruiting
        • Pecsi Tudomanyegyetem
        • Contact:
          • Phone Number: +36 72 536 633
        • Principal Investigator:
          • Adriana Csernus
  • Japan
      • Hamamatsu, Japan, 431-3192
        • Recruiting
        • Hamamatsu University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Taisuke Ito
      • Kurume, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yohei Natsuaki
      • Mitaka, Japan, 181-8611
        • Recruiting
        • Kyorin University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Misaki Kinoshita
      • Miyagi-gun, Japan, 981 0112
        • Recruiting
        • Rifu Dermatology Allergy Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masato Mizuashi
      • Niigata, Japan, 951-8520
        • Recruiting
        • Niigata University Medical & Dental Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Ryota Hayashi
      • Osaka, Japan, 545-8586
        • Recruiting
        • Osaka City University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hisayoshi Imanishi
      • Shinjuku-ku, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kazutoshi Harada
      • Ube, Japan, 755-8505
        • Recruiting
        • Yamaguchi University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yutaka Shimomura
  • Poland
      • Gdansk, Poland, 80-546
        • Recruiting
        • Centrum Badan Klinicznych PI-House sp. z o.o.
        • Principal Investigator:
          • Aleksandra Okuniewska
        • Contact:
          • Phone Number: 587192222
      • Katowice, Poland, 40-611
        • Recruiting
        • Centrum Medyczne Angelius Provita
        • Contact:
          • Phone Number: 607566402
        • Principal Investigator:
          • Anita Lewartowska-Bialek
      • Katowice, Poland, 40 568
        • Recruiting
        • CareClinic
        • Contact:
          • Phone Number: 609527827
        • Principal Investigator:
          • Dominika Wcislo-Dziadecka
      • Kielce, Poland, 25-155
        • Recruiting
        • Gabinet Dermatologiczny
        • Contact:
          • Phone Number: 790258928
        • Principal Investigator:
          • Beata Krecisz
      • Krakow, Poland, 30 002
        • Recruiting
        • Specjalistyczny Gabinet Dermatologiczny s.c.
        • Contact:
          • Phone Number: +48 600244514
        • Principal Investigator:
          • Pawel Brzewski
      • Lodz, Poland, 90-436
        • Recruiting
        • Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
        • Contact:
          • Phone Number: 609279389
        • Principal Investigator:
          • Aleksandra Lesiak
      • Rzeszów, Poland, 35 055
        • Recruiting
        • Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie
        • Contact:
          • Phone Number: 605076722
        • Principal Investigator:
          • Adam Reich
      • Swietokrzyski, Poland, 27 400
        • Recruiting
        • Dermedic Jacek Zdybski
        • Principal Investigator:
          • Piotr Parcheta
        • Contact:
          • Phone Number: +48 693 721 891
      • Warsaw, Poland, 02-625
        • Recruiting
        • Centrum Medyczne Evimed
        • Principal Investigator:
          • Monika Slowinska
        • Contact:
          • Phone Number: 733240763/ 48510175635
      • Warsaw, Poland, 02 647
        • Recruiting
        • Provita Poliklinika Sp. z o.o.
        • Principal Investigator:
          • Mariusz Sikora
        • Contact:
          • Phone Number: 668361281
      • Warsaw, Poland, 02 962
        • Recruiting
        • Royalderm Agnieszka Nawrocka
        • Contact:
          • Phone Number: 601316460
        • Principal Investigator:
          • Witold Owczarek
      • Warsaw, Poland, 02-507
        • Recruiting
        • Centralny Szpital Kliniczny Mswia
        • Contact:
          • Phone Number: 48225081482
        • Principal Investigator:
          • Irena Walecka - Herniczek
      • Warsaw, Poland, 02-953
        • Recruiting
        • Klinika Ambroziak Sp. Z.O.O.
        • Principal Investigator:
          • Justyna Skibinska
        • Contact:
          • Phone Number: 502616031
      • Wroclaw, Poland, 50-566
        • Recruiting
        • CityClinic Przychodnia Lekarsko-Psychologiczna
        • Contact:
          • Phone Number: 601534853
        • Principal Investigator:
          • Jacek Szepietowski
  • South Korea
      • Busan, South Korea, 49241
        • Recruiting
        • Pusan National University Hospital
        • Contact:
          • Phone Number: 51 240 7338
        • Principal Investigator:
          • Moon-Bum Kim
      • Cheonan-si, South Korea, 31116
        • Recruiting
        • Dankook University Hospital
        • Contact:
          • Phone Number: 10 9575 5146
        • Principal Investigator:
          • Byung Cheol Park
      • Daejeon, South Korea, 35015
        • Recruiting
        • Chungnam national university hospital
        • Contact:
          • Phone Number: 10 5456 7348
        • Principal Investigator:
          • Young Lee
      • Incheon, South Korea, 22332
        • Recruiting
        • Inha University Hospital
        • Contact:
          • Phone Number: 32 890 3737
        • Principal Investigator:
          • Gwang Seong Choi
      • Jeonju, South Korea, 54907
        • Recruiting
        • Jeonbuk National University Hospital
        • Contact:
          • Phone Number: 10 3311 8402
        • Principal Investigator:
          • Jin Park
      • Junggu, South Korea, 41944
        • Recruiting
        • Kyungpook National University Hospital
        • Contact:
          • Phone Number: 10 9268 8342
        • Principal Investigator:
          • Yong Hyun Jang
      • Seongnam-si, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Phone Number: 1066147796
        • Principal Investigator:
          • Chang Hun Huh
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Phone Number: 10 5445 9889
        • Principal Investigator:
          • OHSANG KWON
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Contact:
          • Phone Number: 2 2228 2080
        • Principal Investigator:
          • Do Young Kim
      • Seoul, South Korea, 05030
        • Recruiting
        • Konkuk University Medical Center
        • Contact:
          • Phone Number: 10 6286 2138
        • Principal Investigator:
          • Yang-Won Lee
      • Seoul, South Korea, 05278
        • Recruiting
        • Kyunghee University Hospital at Gangdong
        • Contact:
          • Phone Number: 10 8948 7721
        • Principal Investigator:
          • Bark-Lynn Lew
      • Seoul, South Korea, 03312
        • Recruiting
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
        • Contact:
          • Phone Number: 2 2030 2845
        • Principal Investigator:
          • HOON KANG
      • Seoul, South Korea, 06973
        • Recruiting
        • Chung-Ang University College of Medicine - Chung-Ang University Hospital (CAUH)
        • Principal Investigator:
          • Beomjoon Kim
        • Contact:
          • Phone Number: 10 5310 2419
      • Suwon, South Korea, 16499
        • Recruiting
        • Ajou University Hospital
        • Contact:
          • Phone Number: 10 9933 0102
        • Principal Investigator:
          • Jee Woong Choi
  • Spain
      • Badalona, Spain, 08916
        • Recruiting
        • Hospital Universitario Germans Trias i Pujol
        • Contact:
          • Phone Number: 934978754
        • Principal Investigator:
          • Adria Plana Pla
      • Barcelona, Spain, 08003
        • Recruiting
        • Parc de Salut Mar - Hospital del Mar
        • Contact:
          • Phone Number: +34 93 2483211
        • Principal Investigator:
          • Alvaro March Rodriguez
      • Bilbao (Bizkaia), Spain, 48013
        • Completed
        • Hospital Universitario Basurto
      • Madrid, Spain, 28031
        • Recruiting
        • Hospital Universitario Infanta Leonor-INTERNAL MED
        • Contact:
          • Phone Number: 626273207
        • Principal Investigator:
          • Jose Luis Galan
      • Madrid, Spain, 28006
        • Completed
        • Clinica Pedro Jaen
      • Valencia, Spain, 46014
        • Recruiting
        • Hospital General Universitario de Valencia
        • Contact:
          • Phone Number: +34 96 3131800
        • Principal Investigator:
          • Altea Esteve Martinez
  • Taiwan
      • New Taipei City, Taiwan, 235
        • Not yet recruiting
        • Taipei Medical University Shuang Ho Hospital
        • Contact:
          • Phone Number: 222490088
        • Principal Investigator:
          • Woan-Ruoh Lee
      • Taichung, Taiwan, 40201
        • Recruiting
        • Chung Shan Medical University Hospital
        • Principal Investigator:
          • Po-Ju Lai
        • Contact:
          • Phone Number: 910381121
      • Tainan, Taiwan, 70403
        • Not yet recruiting
        • National Cheng Kung University Hospital
        • Contact:
          • Phone Number: +886 62353535
        • Principal Investigator:
          • Chao-Chun Yang
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Phone Number: +886 223562141
        • Principal Investigator:
          • Tsen-Fang Tsai
      • Taipei, Taiwan, 11217
        • Not yet recruiting
        • Taipei Veterans General Hospital
        • Principal Investigator:
          • Chih-Chiang Chen
        • Contact:
          • Phone Number: 228757808
      • Taoyuan, Taiwan, 333
        • Not yet recruiting
        • Chang Gung Medical Foundation-Linkou Branch
        • Contact:
          • Phone Number: 88627135211
        • Principal Investigator:
          • Wen-Hung Chung
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Not yet recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Phone Number: 205-502-9960
        • Principal Investigator:
          • Tiffany Mayo
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • Total Skin and Beauty Dermatology Center, PC
        • Principal Investigator:
          • James Krell
        • Contact:
          • Phone Number: 205.380.6148
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Recruiting
        • Investigate MD
        • Contact:
          • Phone Number: 480-440-5985
        • Principal Investigator:
          • Brenda LaTowsky
    • California
      • Encinitas, California, United States, 92024
        • Not yet recruiting
        • California Dermatology & Clinical Research Institute
        • Principal Investigator:
          • Stacy Smith
        • Contact:
          • Phone Number: 7602033839
      • Los Angeles, California, United States, 90045
        • Recruiting
        • Dermatology Research Associates
        • Contact:
          • Phone Number: 310-337-7171
        • Principal Investigator:
          • Howard Sofen
      • San Diego, California, United States, 92123
        • Recruiting
        • University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
        • Contact:
          • Phone Number: 858-966-1700 ext. 224295
        • Principal Investigator:
          • Dawn Eichenfield
      • San Francisco, California, United States, 94118
        • Recruiting
        • The Permanente Medical Group, Inc.
        • Principal Investigator:
          • Paradi Mirmirani
        • Contact:
          • Phone Number: 7076511000
      • Santa Ana, California, United States, 92701
        • Recruiting
        • Southern California Dermatology, Inc.
        • Principal Investigator:
          • Jennifer Soung
        • Contact:
          • Phone Number: 714-547-5151
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Not yet recruiting
        • Dermatology Physicians of Connecticut
        • Principal Investigator:
          • Brittany Craiglow
        • Contact:
          • Phone Number: 2037854632
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Not yet recruiting
        • Skin Care Research, Inc
        • Principal Investigator:
          • Ann Reed
        • Contact:
          • Phone Number: 561-948-3116 x3053
      • Coral Gables, Florida, United States, 33134
        • Completed
        • Florida Academic Centers Research and Education, LLC
      • Doral, Florida, United States, 33122
        • Not yet recruiting
        • D&H Doral Research Center LLC
        • Contact:
          • Phone Number: 786-698-8508
        • Principal Investigator:
          • Brent Schillinger
      • Hollywood, Florida, United States, 33021
        • Not yet recruiting
        • Skin Care Research, Inc
        • Contact:
          • Phone Number: 954-674-3535
        • Principal Investigator:
          • Eduardo Weiss
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Solutions Through Advanced Research, Inc.
        • Principal Investigator:
          • Pearl Kwong
        • Contact:
          • Phone Number: 904-619-8157
      • Miami, Florida, United States, 33125
        • Not yet recruiting
        • University of Miami Miller School of Medicine
        • Principal Investigator:
          • Mariya Miteva
      • Miami, Florida, United States, 33156
        • Recruiting
        • Pediatric Skin Research, LLC
        • Contact:
          • Phone Number: 786-585-5774
        • Principal Investigator:
          • Mercedes Gonzalez
    • Georgia
      • Macon, Georgia, United States, 31217
        • Recruiting
        • Skin Care Physicians of Georgia
        • Contact:
          • Phone Number: 478-742-2180 ext 255
        • Principal Investigator:
          • David Cohen
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Northwestern University
        • Contact:
          • Phone Number: 312-695-3721
        • Principal Investigator:
          • Amy Paller
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • Northshore University Healthsystem
        • Principal Investigator:
          • Joel Joyce
        • Contact:
          • Phone Number: 847-663-8530
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Dawes Fretzin Clinical Research Group, LLC
        • Contact:
          • Phone Number: 317-516-5030 ext 115
        • Principal Investigator:
          • Kenneth Dawes
      • South Bend, Indiana, United States, 46617
        • Recruiting
        • The South Bend Clinic Center for Research
        • Contact:
          • Phone Number: 574-204-6192
        • Principal Investigator:
          • Holly Hake Harris
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • DermAssociates PC.
        • Principal Investigator:
          • Benjamin Lockshin
        • Contact:
          • Phone Number: 301-355-3183
    • Michigan
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • Michigan Center for Research Company
        • Principal Investigator:
          • Wendy McFalda
        • Contact:
          • Phone Number: 1-248-620-3376
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota Medical School
        • Contact:
          • Phone Number: 612-625-8625
        • Principal Investigator:
          • Maria Hordinsky
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • MediSearch Clinical Trials
        • Principal Investigator:
          • Melody Stone
        • Contact:
          • Phone Number: 816-364-1515
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Advanced Skin Research Center
        • Principal Investigator:
          • Joel Schlessinger
        • Contact:
          • Phone Number: 402-697-6599
    • New York
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Principal Investigator:
          • Holly Kanavy
        • Contact:
          • Phone Number: (718) 920-8352
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Recruiting
        • Onsite Clinical Solutions
        • Contact:
          • Phone Number: 800-785-3150
        • Principal Investigator:
          • Catherine Pointon
      • Charlotte, North Carolina, United States, 28277
        • Recruiting
        • Dermatology Specialists of Charlotte
        • Contact:
          • Phone Number: 7042479179 x212
        • Principal Investigator:
          • Deborah Nixon
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Recruiting
        • Bexley Dermatology Research
        • Principal Investigator:
          • Matthew Zirwas
        • Contact:
          • Phone Number: 614-725-5010
      • Cincinnati, Ohio, United States, 45229
        • Not yet recruiting
        • Cincinnati Childrens Hospital Medical Center
        • Principal Investigator:
          • Kalyani Marathe
        • Contact:
          • Phone Number: 2024763395
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • University Hospitals Cleveland Medical Center
        • Principal Investigator:
          • Neil Korman
        • Contact:
          • Phone Number: 2168445197
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • Vital Prospects Clinical Research Institute, P.C.
        • Principal Investigator:
          • Iftikhar Hussain
        • Contact:
          • Phone Number: 918-392-4550
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Northwest Dermatology Institute
        • Principal Investigator:
          • Nisha Desai
        • Contact:
          • Phone Number: 5032231933
    • Pennsylvania
      • Exton, Pennsylvania, United States, 19341
        • Completed
        • The Pennsylvania Centre for Dermatology, LLC
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Lara Wine Lee
        • Contact:
          • Phone Number: 8437923021
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • Recruiting
        • International Clinical Research - Tennessee (IC Research)
        • Principal Investigator:
          • Christina Feser
        • Contact:
          • Phone Number: (615) 410-3460
    • Texas
      • Dallas, Texas, United States, 75230
        • Not yet recruiting
        • Dermatology Treatment and Research Center
        • Principal Investigator:
          • Ross Radusky
        • Contact:
          • Phone Number: 4697541585
      • Grapevine, Texas, United States, 76051
        • Recruiting
        • Pediatric Dermatology of North Texas
        • Principal Investigator:
          • Fred Ghali
        • Contact:
          • Phone Number: 972-354-1520
      • San Antonio, Texas, United States, 78218
        • Recruiting
        • Texas Dermatology and Laser Specialists
        • Principal Investigator:
          • John Browning
        • Contact:
          • Phone Number: (210) 852-2779 Ext. 1004
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Complete Dermatology
        • Contact:
          • Phone Number: 281-240-4313
        • Principal Investigator:
          • Vandana Madkan
    • Utah
      • Murray, Utah, United States, 84107
        • Not yet recruiting
        • University of Utah MidValley Dematology
        • Principal Investigator:
          • Jamie Rhoads
        • Contact:
          • Phone Number: 801-587-1948
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Clinical Research
        • Contact:
          • Phone Number: 757-625-0151
        • Principal Investigator:
          • David Pariser
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Recruiting
        • University of Wisconsin-Madison
        • Principal Investigator:
          • Lisa Arkin
        • Contact:
          • Phone Number: 6082872450

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Participants will receive placebo
Drug: Placebo
Administered orally
Experimental: Baricitinib High Dose
Participants will receive baricitinib high dose orally.
Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104
Experimental: Baricitinib Low Dose
Participants will receive baricitinib low dose orally.
Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20
Time Frame: Week 36
Week 36

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving At Least 90% Improvement from Baseline (SALT90)
Time Frame: Week 36
Week 36
Percentage of Participants Achieving an Absolute SALT ≤10
Time Frame: Week 36
Week 36
Percentage of Participants Achieving At Least 50% Improvement from Baseline (SALT50)
Time Frame: Week 36
Week 36
Percentage of Participants Achieving At Least 75% Improvement from Baseline (SALT75)
Time Frame: Week 36
Week 36
Percentage of Participants Achieving At Least 100% Improvement from Baseline (SALT100)
Time Frame: Week 36
Week 36
Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 Among Participants with CLinRO Measure for EB Hair Loss ≥2 at Baseline
Time Frame: Week 36
Week 36
Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 Among Participants with CLinRO Measure for EL Hair Loss ≥2 at Baseline
Time Frame: Week 36
Week 36
Mean Change from Baseline in Hospital Anxiety Depression Scale (HADS)
Time Frame: Week 36
The HADS is a participant-rated instrument used to assess both anxiety and depression and is available in a pediatric self-report for participants ≥12 years old. This instrument consists of 14 item questionnaires, each item is rated on a 4-point scale. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.
Week 36
Mean Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety Score
Time Frame: Baseline, Week 36
The PROMIS Anxiety Short Form (8 questions, 8a v2.0) is available in a pediatric self-report (ages 8 to <18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages ≥5 years). Both pediatric self-report and proxy-report versions assess anxiety "in the past seven days". Response options range from 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores are converted to T-Scores with higher scores representing greater anxiety.
Baseline, Week 36
Mean Change from Baseline in PROMIS Depression Score
Time Frame: Baseline, Week 36
The PROMIS Depression Short Form (8a v2.0 and 6a v2.0) is available in a pediatric self-report (ages 8 to <18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages ≥5 years). Both pediatric self-report and proxy-report versions assess depression "in the past seven days." Response options range from 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores are converted to T-Scores with higher scores representing greater depression.
Baseline, Week 36
Pharmacokinetics (PK): Maximum Concentration (Cmax)
Time Frame: Baseline through Week 36
Baseline through Week 36
PK: Area Under the Concentration Curve (AUC)
Time Frame: Baseline through Week 36
Baseline through Week 36
Change of Immunoglobulin G (IgG) Titers
Time Frame: Pre-Vaccination to 4 Weeks and 12 Weeks Post-Vaccination
Pre-Vaccination to 4 Weeks and 12 Weeks Post-Vaccination
Percent Change from Baseline in SALT Score
Time Frame: Baseline, Week 36
Baseline, 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
Time Frame: Week 36
Week 36
Mean Change from Baseline in SALT Score
Time Frame: Baseline, Week 36
Baseline, Week 36
Percentage of Participants Achieving PRO Measure for EB 0 or 1 (Among Participants 12 Years or Older with PRO Measure for EB ≥2 at Baseline)
Time Frame: Week 36
Week 36
Percentage of Participants Achieving PRO Measure for EL 0 or 1 (Among Participants 12 Years or Older with PRO Measure for EL ≥2 at Baseline)
Time Frame: Week 36
Week 36
Mean Change from Baseline in PROMIS Peer Relationship Score
Time Frame: Baseline, Week 36
The PROMIS Peer Relationships Short Form planned to be used in the study measures 2 aspects of social functioning, friendship quality and peer acceptance, and is available in a pediatric self-report (ages 8 to <18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages 5 to <8 years).
Baseline, Week 36
Mean Change from Baseline in Family Dermatology Life Quality Index (FDLQI)
Time Frame: Baseline, Week 36
The FDLQI is a 10-item validated questionnaire designed for adult (>16 years old) family members of participants. The questionnaire is completed by family members of the AA participants (for example, parents/caregivers) and measures the secondary impact of the participant's skin disease on family QoL. Response categories include "not at all/not relevant," "only a little," "quite a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, with unanswered ("not relevant") responses scored as 0.
Baseline, Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16875
  • I4V-MC-JAIO (Other Identifier: Eli Lilly and Company)
  • 2022-502700-78-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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