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

February 28, 2024 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 Period, and a 4-week Post-treatment Follow-up period.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

595

Phase

  • 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

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: -317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425DKG
        • Recruiting
        • Psoriahue Medicina Interdisciplinaria
        • Principal Investigator:
          • Gabriel Alejandro Magariños
        • Contact:
          • Phone Number: +5491150461624
    • Buenos Air
      • Buenos Aires, Buenos Air, Argentina, C1426ABP
        • Not yet recruiting
        • Fundacion Respirar
        • Contact:
          • Phone Number: +5403814200180
        • Principal Investigator:
          • Maria Fernandez
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1027AAP
        • Recruiting
        • Centro de Investigaciones Metabólicas (CINME)
        • Contact:
          • Phone Number: 5491139842833
        • Principal Investigator:
          • Maria Galimberti
      • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1055AA0
        • Recruiting
        • Buenos Aires Skin
        • Contact:
          • Phone Number: +541152190541
        • Principal Investigator:
          • Eugenia Cappetta
      • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1425BEA
        • Recruiting
        • Instituto de Neumonologia y Dermatologia
        • Contact:
          • Phone Number: 5491145404544
        • Principal Investigator:
          • Paula Luna
      • Pilar, Buenos Aires, Argentina, 1629
        • Not yet recruiting
        • Hospital Universitario Austral
        • Contact:
          • Phone Number: +541127690233
        • Principal Investigator:
          • Carla Castro
    • Provincia De Tucuman
      • San Miguel de Tucuman, Provincia De Tucuman, Argentina, 4000
        • Recruiting
        • Hospital del Nino Jesus
        • Contact:
          • Phone Number: +5493815863707
        • Principal Investigator:
          • Maria Fiandrino
    • Tucumán
      • San Miguel De Tucumán, Tucumán, Argentina, T4000AXL
        • Recruiting
        • Centro Medico Privado de Reumatologia
        • Contact:
          • Phone Number: 5403814200180
        • Principal Investigator:
          • Maria Noelia Cecilia
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 02010
        • Recruiting
        • The Skin Hospital
        • Contact:
          • Phone Number: 8651 2027
        • Principal Investigator:
          • Johanna Kuchel
      • St Leonards, New South Wales, Australia, 2065
        • Not yet recruiting
        • Royal North Shore Hospital
        • Contact:
          • Phone Number: 299660625
        • Principal Investigator:
          • Rebecca Saunderson
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Veracity Clinical Research Pty Ltd
        • Principal Investigator:
          • Lynda Spelman
        • Contact:
          • Phone Number: 730391346
    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Sinclair Dermatology
        • Contact:
          • Phone Number: 3 9013 0099
        • Principal Investigator:
          • Samantha Eisman
      • Mitcham, Victoria, Australia, 3132
        • Recruiting
        • Institute for Skin, Health, and Immunity
        • Contact:
          • Phone Number: 412476267
        • Principal Investigator:
          • John Su
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Not yet recruiting
        • Dermatology Research Institute
        • Contact:
          • Phone Number: 4032633376
        • Principal Investigator:
          • Vimal Prajapati
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Recruiting
        • Dr. Chih-Ho Hong Medical Inc.
        • Contact:
          • Phone Number: 604-953-1333
        • Principal Investigator:
          • Gurbir Dhadwal
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Recruiting
        • Wiseman Dermatology Research Inc.
        • Principal Investigator:
          • Marni Wiseman
        • Contact:
          • Phone Number: 204-943-4922
    • Ontario
      • Cobourg, Ontario, Canada, K9A 0Z4
        • Recruiting
        • Skin Health
        • Principal Investigator:
          • Melinda Gooderham
        • Contact:
          • Phone Number: (289) 252-1856
      • Markham, Ontario, Canada, L3P 1X2
        • Recruiting
        • Lynderm Research Inc.
        • Principal Investigator:
          • Charles Lynde
        • Contact:
          • Phone Number: 905-471-8011
      • Toronto, Ontario, Canada, M4W 2N2
        • Recruiting
        • Research Toronto
        • Principal Investigator:
          • Sameh Hanna
        • Contact:
          • Phone Number: 416-962-0123
  • France
      • Brest CEDEX 2, France, 29609
        • Not yet recruiting
        • CHRU de Brest - Hôpital Morvan
        • Contact:
          • Phone Number: 298223333
        • Principal Investigator:
          • Claire Abasq
      • Marseille, France, 13005
        • Not yet recruiting
        • AP-HM CHU Timone
        • Principal Investigator:
          • Stephanie Mallet
      • 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, 6202
        • Recruiting
        • Chu de Nice Hopital de L'Archet
        • Contact:
          • Phone Number: 492036667
        • Principal Investigator:
          • Thierry Passeron
      • Paris, France, 75010
        • Recruiting
        • Centre de Sante Sabouraud
        • Contact:
          • Phone Number: 1424939-37
        • Principal Investigator:
          • Pascal Reygagne
      • Tours Cedex, France, 37044
        • Recruiting
        • Hôpital Clocheville Chru-Tours Département Dermatologie
        • Principal Investigator:
          • Annabel Maruani
        • Contact:
          • Phone Number: 33247474625
  • Germany
      • 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-Universitaet Frankfurt
        • Principal Investigator:
          • Andreas Pinter
        • Contact:
          • Phone Number: 004969630183115
      • Halle, Germany, 06120
        • Not yet recruiting
        • Universitätsklinik und Poliklinik für Dermatologie und Venerologie
        • Contact:
          • Phone Number: +49-345-557 3935
        • Principal Investigator:
          • Johannes Wohlrab
      • Hamburg, Germany, 20246
        • Not yet recruiting
        • Universitaetsklinikum Hamburg-Eppendorf
        • Contact:
          • Phone Number: 040741059504
        • Principal Investigator:
          • Matthias Augustin
      • Hamburg, Germany, 22149
        • Not yet recruiting
        • Kath. Kinderkrankenhaus Wilhelmstift
        • Principal Investigator:
          • Peter H. Hoeger
      • Mainz, Germany, 55128
        • Recruiting
        • Dermatologische Gemeinschaftspraxis Dres. Quist
        • Contact:
          • Phone Number: +49 34196280027
        • Principal Investigator:
          • Sven Quist
      • Muenster, Germany, 48149
        • Not yet recruiting
        • University of Muenster, Dept. of Dermatology, Central Study Coordination for innovative Dermatology
        • Principal Investigator:
          • Nina Magnolo
        • Contact:
          • Phone Number: 2518357296
    • Bayern
      • Muenchen, Bayern, Germany, 80802
        • Not yet recruiting
        • Klinikum rechts der Isar der TU Muenchen
        • Contact:
          • Phone Number: 0049-4140-3231
        • Principal Investigator:
          • Christina Schnopp
    • Niedersachsen
      • Bad Bentheim, Niedersachsen, Germany, 48455
        • Recruiting
        • Fachklinik Bad Bentheim
        • Principal Investigator:
          • Athanasios Tsianakas
        • Contact:
          • Phone Number: 5922745210
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23538
        • Not yet recruiting
        • Universitaetsklinikum Schleswig-Holstein
        • Contact:
          • Phone Number: +4945150041601
        • Principal Investigator:
          • Diamant Thaci
  • Hungary
      • Budapest, Hungary, 1033
        • Not yet recruiting
        • Clinexpert Tatabánya Ltd.
        • Contact:
          • Phone Number: 36303646089
        • Principal Investigator:
          • Dorottya Asboth
      • Pecs, Hungary, 7632
        • Recruiting
        • Pecsi Tudomanyegyetem Klinikai Kozpont
        • Contact:
          • Phone Number: +36 72 536 633
        • Principal Investigator:
          • Adriana Csernus
    • Csongrad
      • Szeged, Csongrad, Hungary, 6720
        • Not yet recruiting
        • University of Szeged
        • Contact:
          • Phone Number: 62 545 277
        • Principal Investigator:
          • Lajos Kemeny
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
        • Contact:
          • Phone Number: 52255204
        • Principal Investigator:
          • Andrea Szegedi
  • Japan
      • Niigata, Japan, 951-8520
        • Recruiting
        • Niigata University Medical & Dental Hospital
        • Contact:
          • Phone Number: 81252236161
        • Principal Investigator:
          • Ryota Hayashi
      • Osaka, Japan, 545-8586
        • Recruiting
        • Osaka City University Hospital
        • Principal Investigator:
          • Hisayoshi Imanishi
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital
        • Contact:
          • Phone Number: 81942353311
        • Principal Investigator:
          • Yohei Natsuaki
    • Miyagi
      • Miyagi-gun, Miyagi, Japan, 981 0112
        • Recruiting
        • Rifu Dermatology Allergy Clinic
        • Contact:
          • Phone Number: +81-22-369-3670
        • Principal Investigator:
          • Masato Mizuashi
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Recruiting
        • Hamamatsu University Hospital
        • Contact:
          • Phone Number: 81534352111
        • Principal Investigator:
          • Taisuke Ito
    • Tokyo
      • Mitaka, Tokyo, Japan, 181-8611
        • Not yet recruiting
        • Kyorin University Hospital
        • Contact:
          • Phone Number: 81422475511
        • Principal Investigator:
          • Misaki Kinoshita
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital
        • Contact:
          • Phone Number: 81333426111
        • Principal Investigator:
          • Kazutoshi Harada
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
        • Recruiting
        • Yamaguchi University Hospital
        • Contact:
          • Phone Number: 81836222111
        • Principal Investigator:
          • Yutaka Shimomura
  • Korea, Republic of
      • Jeonju-si, Korea, Republic of, 54907
        • Recruiting
        • Jeonbuk National University Hospital
        • Contact:
          • Phone Number: 10 3311 8402
        • Principal Investigator:
          • Jin Park
      • Seoul, Korea, Republic of, 06973
        • Recruiting
        • Chung-ang University Hospital
        • Principal Investigator:
          • Beomjoon Kim
        • Contact:
          • Phone Number: 10 5310 2419
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Contact:
          • Phone Number: 2 2228 2080
        • Principal Investigator:
          • Do Young Kim
      • Seoul, Korea, Republic of, 143729
        • Not yet recruiting
        • Konkuk University Medical Center
        • Contact:
          • Phone Number: 10 6286 2138
        • Principal Investigator:
          • Yang won Lee
    • Chungcheongnam-do [Chungnam]
      • Cheonan-si, Chungcheongnam-do [Chungnam], Korea, Republic of, 31116
        • Recruiting
        • Dankook University Hospital
        • Contact:
          • Phone Number: 10 9575 5146
        • Principal Investigator:
          • Byung Cheol Park
    • Geonggi-do
      • Seongnam-si, Geonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Phone Number: 1066147796
        • Principal Investigator:
          • Chang Hun Huh
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • Recruiting
        • Ajou University Hospital
        • Contact:
          • Phone Number: 10 9933 0102
        • Principal Investigator:
          • Jee Woong Choi
    • Incheon-gwangyeoksi [Incheon]
      • Incheon, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 22332
        • Recruiting
        • Inha University Hospital
        • Contact:
          • Phone Number: 32 890 3737
        • Principal Investigator:
          • Gwang Seong Choi
    • Jung-gu
      • Daejeon, Jung-gu, Korea, Republic of, 34134
        • Recruiting
        • Chungnam University Hospital
        • Contact:
          • Phone Number: 10 5456 7348
        • Principal Investigator:
          • Young Lee
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, Korea, Republic of, 49241
        • Recruiting
        • Pusan National University Hospital
        • Contact:
          • Phone Number: 51 240 7338
        • Principal Investigator:
          • Moon-Bum Kim
    • Seoul, Korea
      • Seoul, Seoul, Korea, Korea, Republic of, 05278
        • Recruiting
        • Kyunghee University Hospital at Gangdong
        • Contact:
          • Phone Number: 10 8948 7721
        • Principal Investigator:
          • Bark-Lynn Lew
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Phone Number: 10 5445 9889
        • Principal Investigator:
          • OHSANG KWON
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03312
        • Recruiting
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
        • Contact:
          • Phone Number: 2 2030 2845
        • Principal Investigator:
          • HOON KANG
    • Taegu-Kwangyǒkshi
      • Jung-gu, Taegu-Kwangyǒkshi, Korea, Republic of, 41944
        • Recruiting
        • Kyung Pook National University Hospital
        • Contact:
          • Phone Number: 10 9268 8342
        • Principal Investigator:
          • Yong Hyun Jang
  • Mexico
      • Chihuahua, Mexico, 31217
        • Not yet recruiting
        • Hospital Angeles Chihuahua Unidad de Investigacion Clinica
        • Contact:
          • Phone Number: +52 61 4439 8670
        • Principal Investigator:
          • Erin Gabriela Mariscal Porras
      • Mexico City, Mexico, 14090
        • Not yet recruiting
        • Innovacion y Desarrollo de Estrategias en Salud SA de CV
        • Contact:
          • Phone Number: +52 55 4966 1531
        • Principal Investigator:
          • Guadalupe Maldonado-Colin
      • Mexico City, Mexico, 6720
        • Not yet recruiting
        • Mexico Centre for Clinical Research
        • Contact:
          • Phone Number: 2434 +52 5228 9917
        • Principal Investigator:
          • MIRNA TOLEDO BAHENA
      • Veracruz, Mexico, 91910
        • Not yet recruiting
        • Arké SMO S.A de C.V
        • Principal Investigator:
          • Claudia Bernabe del Rio
        • Contact:
          • Phone Number: 522299314102
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44638
        • Not yet recruiting
        • Grupo Clínico Catei Sc
        • Contact:
          • Phone Number: +52 33 3044 7001
        • Principal Investigator:
          • Delfina Villanueva Quintero
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64718
        • Not yet recruiting
        • Eukarya PharmaSite
        • Contact:
          • Phone Number: +52 1 (81) 23175540
        • Principal Investigator:
          • Minerva Gomez Flores
      • Monterrey, Nuevo León, Mexico, 64460
        • Not yet recruiting
        • Hospital Universitario Dr. Jose Eleuterio Gonzalez
        • Contact:
          • Phone Number: +53 81 8389 1111
        • Principal Investigator:
          • Jorge Ocampo Candiani
  • Poland
      • Bialystok, Poland, 15-453
        • Not yet recruiting
        • NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL
        • Principal Investigator:
          • Adam Wronski
        • Contact:
          • Phone Number: 601277091
      • Bydgoszcz, Poland, 85-065
        • Not yet recruiting
        • Medicover Integrated Clinical Services (MICS) Centrum Medyczne Bydgoszcz
        • Principal Investigator:
          • Mariusz Sulik
        • Contact:
          • Phone Number: 523401414
      • Katowice, Poland, 40-568
        • Recruiting
        • CareClinic
        • Contact:
          • Phone Number: 609527827
        • Principal Investigator:
          • Dominika Wcislo-Dziadecka
      • Kielce, Poland, 25-155
        • Recruiting
        • Gabinet Dermatlogiczny. Beata Krecisz
        • Contact:
          • Phone Number: 790258928
        • Principal Investigator:
          • Beata Krecisz
      • Ostrowiec Swietokrzyski, Poland, 27-400
        • Recruiting
        • Dermedic Jacek Zdybski
        • Principal Investigator:
          • Piotr Parcheta
        • Contact:
          • Phone Number: +48 693 721 891
      • Szczecin, Poland, 70-332
        • Not yet recruiting
        • Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
        • Principal Investigator:
          • Katarzyna Turek-Urasinska
      • Warszawa, Poland, 02-625
        • Recruiting
        • Centrum Medyczne Evimed
        • Principal Investigator:
          • Monika Slowinska
        • Contact:
          • Phone Number: 733240763
      • Warszawa, Poland, 02-692
        • Recruiting
        • Royalderm Agnieszka Nawrocka
        • Contact:
          • Phone Number: 601316460
        • Principal Investigator:
          • Witold Owczarek
      • Warszawa, Poland, 02-953
        • Recruiting
        • Klinika Ambroziak Sp. Z.O.O.
        • Principal Investigator:
          • Justyna Skibinska
        • Contact:
          • Phone Number: 502616031
      • Warszawa, Poland, 02-647
        • Recruiting
        • Provita Poliklinika Sp. z o
        • Principal Investigator:
          • Mariusz Sikora
        • Contact:
          • Phone Number: 668361281
      • Wroclaw, Poland, 50-566
        • Recruiting
        • CityClinic Przychodnia Lekarsko-Psychologiczna
        • Contact:
          • Phone Number: 601534853
        • Principal Investigator:
          • Jacek Szepietowski
    • Lodzkie
      • Lodz, Lodzkie, Poland, 90-436
        • Recruiting
        • Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
        • Contact:
          • Phone Number: 609279389
        • Principal Investigator:
          • Aleksandra Lesiak
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-002
        • Recruiting
        • Specjalistyczny Gabinet Dermatologiczny s.c.
        • Contact:
          • Phone Number: +48 600244514
        • Principal Investigator:
          • Pawel Brzewski
    • Masovian
      • Warsaw, Masovian, Poland, 01-817
        • Not yet recruiting
        • High-Med Przychodnia Specjalistyczna
        • Contact:
          • Phone Number: 693723499
        • Principal Investigator:
          • Dorota Bystrzanowska
    • Małopolskie
      • Warsaw, Małopolskie, Poland, 02-507
        • Recruiting
        • Centralny Szpital Kliniczny MSWiA w Warszawie
        • Contact:
          • Phone Number: 48225081482
        • Principal Investigator:
          • Irena Walecka Herniczek
    • Podkarpackie
      • Rzeszow, Podkarpackie, Poland, 35-055
        • Recruiting
        • Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie
        • Contact:
          • Phone Number: 605076722
        • Principal Investigator:
          • Adam Reich
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-546
        • Recruiting
        • Centrum Badan Klinicznych PI-House sp. z o.o.
        • Principal Investigator:
          • Aleksandra Okuniewska
        • Contact:
          • Phone Number: 587192222
    • Śląskie
      • Katowice, Śląskie, Poland, 40-611
        • Recruiting
        • Centrum Medyczne Angelius Provita
        • Contact:
          • Phone Number: 607566402
        • Principal Investigator:
          • Magdalena Kolanko
  • Spain
      • Alicante, Spain, 03010
        • Not yet recruiting
        • Hospital General Universitario de Alicante
        • Contact:
          • Phone Number: 965 913 723
        • Principal Investigator:
          • Maria Isabel Betlloch Mas
      • Badalona, Spain, 08916
        • Not yet recruiting
        • Hospital Universitari Germans Trias i Pujol (HUGTP)
        • Contact:
          • Phone Number: 934978754
        • Principal Investigator:
          • Adria Plana Pla
      • Bilbao, Spain, 48013
        • Recruiting
        • Hospital Universitario Basurto
        • Contact:
          • Phone Number: 944006063
        • Principal Investigator:
          • Rosa María Izu Belloso
      • Madrid, Spain, 28031
        • Recruiting
        • Hospital Universitario Infanta Leonor
        • Contact:
          • Phone Number: 626273207
        • Principal Investigator:
          • Pablo de la Cueva
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • Sara Isabel Palencia Perez
        • Contact:
          • Phone Number: +34 91 7792261
      • Madrid, Spain, 28006
        • Recruiting
        • Clinica Pedro Jaen
        • Contact:
          • Phone Number: 913 36 80 00
        • Principal Investigator:
          • David Saceda-Corralo
      • Pamplona, Spain, 31008
        • Not yet recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Phone Number: +34 94 8255400
        • Principal Investigator:
          • Leyre Aguado Gil
      • Pozuelo de Alarcon, Spain, 28223
        • Not yet recruiting
        • Hospital Universitario Quiron Salud Madrid
        • Contact:
          • Phone Number: 647415381
        • Principal Investigator:
          • Javier Pedraz Munoz
      • Valencia, Spain, 46014
        • Recruiting
        • Hospital General Universitario de Valencia
        • Contact:
          • Phone Number: +34 96 3131800
        • Principal Investigator:
          • Altea Esteve Martinez
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08003
        • Recruiting
        • Hospital Del Mar
        • Contact:
          • Phone Number: +34 93 2483211
        • Principal Investigator:
          • Alejandro Lobato-Berezo
  • Taiwan
      • Tainan, Taiwan, 70403
        • Not yet recruiting
        • National Cheng Kung University Hospital
        • Contact:
          • Phone Number: +886 62353535
        • Principal Investigator:
          • Chao-Chun Yang
      • Taipei, Taiwan, 10002
        • 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, 33305
        • Not yet recruiting
        • Chang Gung Memorial Hospital - Taipei
        • Contact:
          • Phone Number: 88627135211
        • Principal Investigator:
          • Wen-Hung Chung
    • New Taipei
      • New Taipei City, New Taipei, Taiwan, 235
        • Not yet recruiting
        • Taipei Medical University Shuang Ho Hospital
        • Contact:
          • Phone Number: 222490088
        • Principal Investigator:
          • Woan-Ruoh Lee
    • Taichung
      • Taichung City, Taichung, Taiwan, 40201
        • Recruiting
        • Chung Shan Medical University Hospital
        • Principal Investigator:
          • Po-Ju Lai
        • Contact:
          • Phone Number: 910381121
  • 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
        • Contact:
          • Phone Number: 205-380-6148
        • Principal Investigator:
          • James M Krell
    • 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
        • Contact:
          • Phone Number: 760-203-3839
        • Principal Investigator:
          • Stacy Smith
      • 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
        • Principal Investigator:
          • Dawn Eichenfield
        • Contact:
          • Phone Number: 224295 858-966-1700
      • San Francisco, California, United States, 94118
        • Not yet recruiting
        • The Permanente Medical Group, Inc.
        • Contact:
          • Phone Number: 707-651-1000
        • Principal Investigator:
          • Paradi Mirmirani
      • 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
        • Contact:
          • Phone Number: 203-785-4632
        • Principal Investigator:
          • Brittany Craiglow
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Not yet recruiting
        • Skin Care Research, Inc
        • Principal Investigator:
          • Ann Reed
        • Contact:
          • Phone Number: 3053 561-948-3116
      • Coral Gables, Florida, United States, 33134
        • Recruiting
        • Florida Academic Centers Research and Education, LLC
        • Contact:
          • Phone Number: 954-743-0747
        • Principal Investigator:
          • Francisco Kerdel
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • Pediatric Skin Research, LLC
        • Contact:
          • Phone Number: 786-585-5774
        • Principal Investigator:
          • Mercedes Gonzalez
      • 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
        • 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
        • Contact:
          • Phone Number: 305-243-6704
        • Principal Investigator:
          • Mariya Miteva
      • Tampa, Florida, United States, 33613-1244
        • Not yet recruiting
        • Forcare Clinical Research
        • Principal Investigator:
          • Seth B Forman
        • Contact:
          • Phone Number: 813-264-2155
    • Georgia
      • Macon, Georgia, United States, 31217
        • Recruiting
        • Skin Care Physicians of Georgia
        • Principal Investigator:
          • David Cohen
        • Contact:
          • Phone Number: 255 478-742-2180
    • 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: 115 317-516-5030
        • 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 Lynne Hake Harris
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • DermAssociates PC.
        • Principal Investigator:
          • Benjamin Lockshin
        • Contact:
          • Phone Number: 301-355-3183
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Not yet recruiting
        • Great Lakes Research Group, Inc.
        • Contact:
          • Phone Number: 989-895-9100
        • Principal Investigator:
          • Brent Boyce
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • Michigan Center for Research Company
        • Contact:
          • Phone Number: 248-620-3376
        • Principal Investigator:
          • Wendy McFalda
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Not yet 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
        • Contact:
          • Phone Number: 816-364-1515
        • Principal Investigator:
          • MELODY L STONE
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Advanced Skin Research Center
        • Principal Investigator:
          • Joel Schlessinger
        • Contact:
          • Phone Number: 402-697-6599
    • New York
      • Bronx, New York, United States, 10467
        • Not yet recruiting
        • Montefiore Medical Center
        • Contact:
          • Phone Number: 718-920-8352
        • Principal Investigator:
          • Holly Kanavy
    • 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
        • Principal Investigator:
          • Deborah Nixon
        • Contact:
          • Phone Number: 212 704-247-9179
    • 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
        • Contact:
          • Phone Number: 202-476-3395
        • Principal Investigator:
          • Kalyani Marathe
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • University Hospitals Cleveland Medical Center
        • Principal Investigator:
          • Neil Korman
        • Contact:
          • Phone Number: 216-844-5197
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • Vital Prospects Clinical Research Institute, PC
        • Principal Investigator:
          • Iftikhar Hussain
        • Contact:
          • Phone Number: 918-392-4550
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Northwest Dermatology Institute
        • Contact:
          • Phone Number: 503-223-1933
        • Principal Investigator:
          • Nisha Desai
    • Pennsylvania
      • Exton, Pennsylvania, United States, 19341
        • Recruiting
        • The Pennsylvania Centre for Dermatology, LLC
        • Contact:
          • Phone Number: 610-594-6660
        • Principal Investigator:
          • Scott Gottlieb
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Lara Wine Lee
        • Contact:
          • Phone Number: 843-792-3021
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • Recruiting
        • International Clinical Research
        • Contact:
          • Phone Number: 615-410-3460
        • Principal Investigator:
          • Christine Feser
    • Texas
      • Dallas, Texas, United States, 75230
        • Not yet recruiting
        • Dermatology Treatment and Research Center
        • Contact:
          • Phone Number: 469-754-1585
        • Principal Investigator:
          • Ross Radusky
      • Grapevine, Texas, United States, 76051
        • Recruiting
        • Pediatric Dermatology of North Texas
        • Principal Investigator:
          • Fred Ghali
        • Contact:
          • Phone Number: 972-354-1520
      • Pflugerville, Texas, United States, 78660
        • Not yet recruiting
        • Austin Institute for Clinical Research
        • Contact:
          • Phone Number: 512-279-2545
        • Principal Investigator:
          • Edward Lain
      • San Antonio, Texas, United States, 78218
        • Recruiting
        • Texas Dermatology and Laser Specialists
        • Principal Investigator:
          • John Browning
        • Contact:
          • Phone Number: 1004 210-852-2779
      • 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, Inc.
        • Contact:
          • Phone Number: 757-625-0151
        • Principal Investigator:
          • David M. Pariser
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Recruiting
        • University of Wisconsin-Madison
        • Principal Investigator:
          • Lisa Arkin
        • Contact:
          • Phone Number: 608-287-2450

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

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
Intervention / Treatment
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

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

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

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 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)

February 27, 2023

Primary Completion (Estimated)

April 9, 2025

Study Completion (Estimated)

August 10, 2029

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

February 3, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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