A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata

Last updated: January 20, 2025
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Alopecia

Hair Loss

Treatment

Baricitinib

Placebo

Clinical Study ID

NCT03899259
16978
I4V-MC-JAIR
  • Ages 18-70
  • All Genders

Study Summary

The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Are at least 18 years and ≤60 years for males (≤70 years of age for females) at thetime of informed consent.

  • Have severe or very severe AA, as determined by all of the following:

  • Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured by SALT (AA-IGA of 3 or 4) at screening andbaseline.

  • No spontaneous improvement over the past 6 months.

  • Current episode of severe or very severe AA of less than 8 years. Note:participants who have severe or very severe AA for ≥8 years may be enrolled ifepisodes of regrowth, spontaneous or under treatment, have been observed on theaffected areas over the past 8 years.

  • Male or nonpregnant, nonbreastfeeding female participants.

Exclusion

Exclusion Criteria:

  • Primarily "diffuse" type of AA.

  • Are currently experiencing other forms of alopecia or any other concomitantconditions that would interfere with evaluations of the effect of study medicationon AA.

  • Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequateresponse (for example, absence of significant terminal hair growth after at least 12weeks of treatment).

Study Design

Total Participants: 546
Treatment Group(s): 2
Primary Treatment: Baricitinib
Phase: 3
Study Start date:
July 08, 2019
Estimated Completion Date:
November 19, 2024

Connect with a study center

  • Stat Research

    Caba, Buenos Aires C1023AAB
    Argentina

    Site Not Available

  • Instituto de Neumonología y Dermatología

    Capital Federal, Buenos Aires 1425
    Argentina

    Site Not Available

  • Stat Research

    Ciudad Autonoma De Buenos Air, Buenos Aires C1013AAB
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aires, Buenos Aires 1027
    Argentina

    Site Not Available

  • Fundacion Respirar

    Buenos Aires, Ciudad Autonoma Buenos Aires C1426ABO
    Argentina

    Site Not Available

  • Buenos Aires Skin

    Buenos Aires, Ciudad Autónoma De Buenos Aires 1055
    Argentina

    Site Not Available

  • Centro Medico Privado de Reumatologia

    SAN M. DE Tucuman, Tucuman T4000AXL
    Argentina

    Site Not Available

  • Centro de Investigaciones Médicas Tucuman

    SAN M. DE Tucuman, Tucuman T4000AXL
    Argentina

    Site Not Available

  • Centro Medico Privado de Reumatologia

    San Miguel de Tucuman, Tucuman T4000AXL
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1027AAP
    Argentina

    Site Not Available

  • Buenos Aires Skin

    Ciudad Autonoma Buenos Aires, C1055AA0
    Argentina

    Site Not Available

  • Instituto de Neumonología y Dermatología

    Ciudad Autonoma Buenos Aires, 1425
    Argentina

    Site Not Available

  • Parra Dermatología

    Mendoza, 5500
    Argentina

    Site Not Available

  • Centro Medico Privado de Reumatologia

    Tucuman, T4000AXL
    Argentina

    Site Not Available

  • Woden Dermatology

    Phillip, Australian Capital Territory 2606
    Australia

    Site Not Available

  • Skin & Cancer Foundation Australia

    Westmead, New South Wales 2045
    Australia

    Site Not Available

  • Veracity Clinical Research Pty Ltd

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Clinical Trials SA Pty Ltd

    Adelaide, South Australia 5073
    Australia

    Site Not Available

  • Clinical Trials SA Pty Ltd

    Campbelltown, South Australia 5073
    Australia

    Site Not Available

  • Skin Health Institute Inc.

    Carlton, Victoria 3053
    Australia

    Site Not Available

  • Sinclair Dermatology

    Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Fremantle Dermatology

    Fremantle, Western Australia 6160
    Australia

    Site Not Available

  • Fremantle Dermatology

    Perth, Western Australia 6160
    Australia

    Site Not Available

  • Sinclair Dermatology

    Victoria, 3002
    Australia

    Site Not Available

  • IDERJ - Instituto de Dermatologia e Estética do Brasil

    Rio de Janeiro, RJ 22470-220
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90050-170
    Brazil

    Site Not Available

  • Faculdade de Ciências Médicas - UNICAMP

    Campinas, Sao Paulo 13083-888
    Brazil

    Site Not Available

  • Hospital de Clínicas Da Universidade Estadual de Campinas

    Campinas, Sao Paulo 13083-888
    Brazil

    Site Not Available

  • Faculdade de Medicina do ABC

    Santo André, Sao Paulo 09060-870
    Brazil

    Site Not Available

  • Fundação Faculdade de Medicina do ABC

    Santo André, Sao Paulo 09060-870
    Brazil

    Site Not Available

  • Centro de Pesquisa Sao Lucas

    Campinas, São Paulo 13034-685
    Brazil

    Site Not Available

  • Hospital PUC-CAMPINAS

    Campinas, São Paulo 13060-904
    Brazil

    Site Not Available

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 22241-180
    Brazil

    Site Not Available

  • Instituto Brasil de Pesquisa Clínica - IBPCLIN

    Rio de Janeiro, 20241180
    Brazil

    Site Not Available

  • Hospital Central - Santa Casa de São Paulo

    São Paulo, 01223-001
    Brazil

    Site Not Available

  • Hospital de Servidor Publico Estadual

    São Paulo, 04039-901
    Brazil

    Site Not Available

  • IPITEC

    São Paulo, 01223-001
    Brazil

    Site Not Available

  • Santa Casa Da Misericórdia De São Paulo

    São Paulo, 01221-020
    Brazil

    Site Not Available

  • Servidor Público Estadual - IAMSPE - centro de estudos urológicos

    São Paulo, 04039-901
    Brazil

    Site Not Available

  • Beijing Chao Yang Hospital

    Beijing, Beijing 100020
    China

    Site Not Available

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, Beijing 100020
    China

    Site Not Available

  • Beijing Friendship Hospital Affiliate of Capital University

    Beijing, Beijing 100050
    China

    Site Not Available

  • Chinese PLA General Hospital

    Beijing, Beijing 100853
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • Dermatology Hospital of Southern Medical University (Guangdong Provincial Dermatology Hospital)

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Guangdong Province Dermatology Hospital

    Guangzhou, Guangdong 510018
    China

    Site Not Available

  • Hongkong University Shenzhen Hospital

    Shenzhen, Guangdong 518000
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 212000
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'An, Shaanxi 710004
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'An, Shaanxi 710004
    China

    Site Not Available

  • 1st affiliated Hospital of Shanxi Medical University

    Tai Yuan, Shan XI 30001
    China

    Site Not Available

  • HuaShan Hospital Affiliated To Fudan University

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai 200071
    China

    Site Not Available

  • First Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi 30001
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310052
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 310014
    China

    Site Not Available

  • Shanghai Dermatology Hospital

    Shanghai, 200071
    China

    Site Not Available

  • Soroka Medical Center

    Beer Sheva, HaDarom 8410101
    Israel

    Site Not Available

  • Rabin Medical Center

    Petach Tikva, HaMerkaz 4941492
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, HaMerkaz 5262100
    Israel

    Site Not Available

  • Emek Medical Center

    Afula, HaTsafon 1834111
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa, HaTsafon 3109601
    Israel

    Site Not Available

  • Sourasky Medical Center

    Tel Aviv, Tell Abīb 6423906
    Israel

    Site Not Available

  • Hadassah Medical Center

    Jerusalem, Yerushalayim 9112001
    Israel

    Site Not Available

  • Ha'Emek Medical Center

    Afula, 1834111
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Yokohama Rosai Hospital

    Yokohama, Kanagawa 222-0036
    Japan

    Site Not Available

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka 431-3192
    Japan

    Site Not Available

  • Hamamatsu University School of Medicine, University Hospital

    Hamamatsu, Shizuoka 431-3192
    Japan

    Site Not Available

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Site Not Available

  • Juntendo Tokyo Koto Geriatric Medical Center

    Koto-ku, Tokyo 136-0075
    Japan

    Site Not Available

  • Kyorin University Hospital

    Mitaka, Tokyo 181-8611
    Japan

    Site Not Available

  • Tokyo Medical Univ. Hospital

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Site Not Available

  • Yamaguchi University Hospital

    Ube, Yamaguchi 755-8505
    Japan

    Site Not Available

  • Osaka City University Hospital

    Osaka, 545-8586
    Japan

    Site Not Available

  • Juntendo Tokyo Koto Geriatric Medical Center

    Tokyo, 136-0075
    Japan

    Site Not Available

  • Dankook University Hospital

    Cheonan, Chungcheongnam-do 31116
    Korea, Republic of

    Site Not Available

  • Soonchunhyang University Bucheon Hospital

    Bucheon, Gyeonggi-do 14584
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon, Gyeonggi-do 16499
    Korea, Republic of

    Site Not Available

  • Yonse University Wonju Severance Christian Hospital

    Gangwon-do, Kang Won-do 26426
    Korea, Republic of

    Site Not Available

  • Boramae Medical Center

    Dongjak-gu, Seoul-teukbyeolsi [Seoul] 07061
    Korea, Republic of

    Site Not Available

  • Kyunghee University Hospital at Gangdong

    Seoul, Seoul-teukbyeolsi [Seoul] 134-090
    Korea, Republic of

    Site Not Available

  • Seoul National University Boramae Medical Center

    Seoul, 07061
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Clinical Research Puerto Rico

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung city, Taichung 402
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung City (r.o.c), 402
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital - Taipei

    Taipei, 10508
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei City, 10002
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Total Skin and Beauty Dermatology Center, PC

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Investigate MD

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Northwest Arkansas Clinical Trials Center

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • First OC Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Center For Dermatology Clinical Research, Inc.

    Fremont, California 94538
    United States

    Site Not Available

  • Quest Dermatology Research

    Northridge, California 91324
    United States

    Site Not Available

  • Kaiser Permanente Hospital

    San Francisco, California 94118
    United States

    Site Not Available

  • New England Research Associates

    Bridgeport, Connecticut 06606
    United States

    Site Not Available

  • Florida Academic Centers Research and Education, LLC

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Site Not Available

  • ForCare Clinical Research

    Tampa, Florida 33613-1244
    United States

    Site Not Available

  • Qualmedica Research, LLC

    Evansville, Indiana 47715
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • The South Bend Clinic Center for Research

    South Bend, Indiana 46617
    United States

    Site Not Available

  • Forefront Clinical Research

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Qualmedica Research LLC

    Owensboro, Kentucky 42301
    United States

    Site Not Available

  • Qualmedica Research, LLC

    Owensboro, Kentucky 42303
    United States

    Site Not Available

  • Dermatology and Skin Cancer Specialists

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
    United States

    Site Not Available

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan 48047
    United States

    Site Not Available

  • Hamzavi Dermatology

    Fort Gratiot, Michigan 48059
    United States

    Site Not Available

  • Minnesota Clinical Study Center

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Associated Skin Care Specialists

    New Brighton, Minnesota 55112
    United States

    Site Not Available

  • MediSearch Clinical Trials

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756-0001
    United States

    Site Not Available

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Joseph J. Schwartz, M.D.

    Troy, New York 12180
    United States

    Site Not Available

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27516
    United States

    Site Not Available

  • University of North Carolina Dermatology and Skin Cancer Cen

    Chapel Hill, North Carolina 27516
    United States

    Site Not Available

  • Dermatology Specialists of Charlotte

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • Skin Wellness Dermatology Associates

    Durham, North Carolina 27713
    United States

    Site Not Available

  • M3-Emerging Medical Research

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Wake Research Associates

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Bexley Dermatology Research

    Bexley, Ohio 43209
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Dermatologists of Southwest Ohio

    Mason, Ohio 45040
    United States

    Site Not Available

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • NW Dermatology & Research Center, LLC

    Portland, Oregon 97210
    United States

    Site Not Available

  • Northwest Dermatology Institute

    Portland, Oregon 97210
    United States

    Site Not Available

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • Center for Medical Research, LLC

    Providence, Rhode Island 02908
    United States

    Site Not Available

  • Omega Medical Research

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • Suzanne Bruce and Associates, PA

    Houston, Texas 77056
    United States

    Site Not Available

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia 23502
    United States

    Site Not Available

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