A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
NCT ID: NCT03899259
Last Updated: 2025-01-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
546 participants
INTERVENTIONAL
2019-07-08
2024-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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4 Milligram (mg) Baricitinib
Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.
Baricitinib
Administered orally
Placebo
Administered orally
2 mg Baricitinib
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.
Baricitinib
Administered orally
Placebo
Administered orally
Placebo
Participants received two placebo tablets administered orally QD to maintain the blind.
Placebo
Administered orally
4 mg Baricitinib Maximum Extended Enrollment (MEE)
Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.
Baricitinib
Administered orally
Placebo
Administered orally
2 mg Baricitinib MEE
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.
Baricitinib
Administered orally
Placebo MEE
Participants received two placebo tablets administered orally QD to maintain the blind.
Placebo
Administered orally
Interventions
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Baricitinib
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 and baseline.
* 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 if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years.
* Male or nonpregnant, nonbreastfeeding female participants.
Exclusion Criteria
* Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA.
* Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment).
18 Years
70 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
Investigate MD
Scottsdale, Arizona, United States
Center For Dermatology Clinical Research, Inc.
Fremont, California, United States
Quest Dermatology Research
Northridge, California, United States
Kaiser Permanente Hospital
San Francisco, California, United States
New England Research Associates
Bridgeport, Connecticut, United States
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, United States
New Horizon Research Center
Miami, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
The South Bend Clinic Center for Research
South Bend, Indiana, United States
Qualmedica Research, LLC
Owensboro, Kentucky, United States
Dermatology and Skin Cancer Specialists
Rockville, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Associated Skin Care Specialists
New Brighton, Minnesota, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Joseph J. Schwartz, M.D.
Troy, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Dermatology Specialists of Charlotte
Charlotte, North Carolina, United States
M3-Emerging Medical Research
Raleigh, North Carolina, United States
Bexley Dermatology Research
Bexley, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Dermatologists of Southwest Ohio
Mason, Ohio, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States
Northwest Dermatology Institute
Portland, Oregon, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States
Suzanne Bruce and Associates, PA
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Stat Research
CABA, Buenos Aires, Argentina
Instituto de Neumonología y Dermatología
Capital Federal, Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Buenos Aires Skin
Buenos Aires, Buenos Aires F.D., Argentina
Fundacion Respirar
Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province, Argentina
Parra Dermatología
Mendoza, , Argentina
Woden Dermatology
Phillip, Australian Capital Territory, Australia
Skin & Cancer Foundation Australia
Westmead, New South Wales, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia
Clinical Trials SA Pty Ltd
Campbelltown, South Australia, Australia
Skin Health Institute Inc.
Carlton, Victoria, Australia
Sinclair Dermatology
Melbourne, Victoria, Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia
IDERJ - Instituto de Dermatologia e Estética do Brasil
Rio de Janeiro, Rio de Janeiro, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, Brazil
Hospital de Clínicas Da Universidade Estadual de Campinas
Campinas, São Paulo, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, , Brazil
IPITEC
São Paulo, , Brazil
Servidor Público Estadual - IAMSPE - centro de estudos urológicos
São Paulo, , Brazil
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Friendship Hospital Affiliate of Capital University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Guangdong Province Dermatology Hospital
Guangzhou, Guangdong, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
HuaShan Hospital Affiliated To Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Rabin Medical Center
Petah Tikva, Central District, Israel
Sheba Medical Center
Ramat Gan, Central District, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Emek Medical Center
Afula, Northern District, Israel
Rambam Medical Center
Haifa, Northern District, Israel
Soroka Medical Center
Beersheba, Southern District, Israel
Sourasky Medical Center
Tel Aviv, Tell Abīb, Israel
Yokohama Rosai Hospital
Yokohama, Kanagawa, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Juntendo Tokyo Koto Geriatric Medical Center
Koto-ku, Tokyo, Japan
Kyorin University Hospital
Mitaka, Tokyo, Japan
Tokyo Medical Univ. Hospital
Shinjuku-ku, Tokyo, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Osaka City University Hospital
Osaka, , Japan
Clinical Research Puerto Rico
San Juan, , Puerto Rico
Dankook University Hospital
Cheonan, Chungcheongnam-do, South Korea
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Boramae Medical Center
Dongjak-gu, Seoul-teukbyeolsi [Seoul], South Korea
Kyunghee University Hospital at Gangdong
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Chung Shan Medical University Hospital
Taichung, Taichung, Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Countries
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References
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King B, Mostaghimi A, Shimomura Y, Piraccini BM, Blume-Peytavi U, Sontag A, Dutronc Y, Denning K, Kolodsick J, Lu X, Srivastava A, Sinclair R. Safety of Baricitinib in Adults with Severe Alopecia Areata from Two Phase III Trials Over a Median of 2.3 Years and Up to 4 Years of Treatment. Am J Clin Dermatol. 2025 Jul;26(4):611-622. doi: 10.1007/s40257-025-00932-0. Epub 2025 Apr 11.
Craiglow B, Lee YW, Vano-Galvan S, Egeberg A, Dutronc Y, Durand F, Pierce E, Yu G, Chen YF, Mostaghimi A. Improvement in Measures of Quality of Life and Symptoms of Anxiety and Depression in Patients with Severe Alopecia Areata Achieving Sustained Scalp Hair Regrowth with Baricitinib. Dermatol Ther (Heidelb). 2024 Jul;14(7):1959-1968. doi: 10.1007/s13555-024-01208-x. Epub 2024 Jun 21.
Senna MM, Kwon O, Piraccini BM, Sinclair R, Ball S, Ding Y, Chen YF, Dutronc Y, King B. Clinical Benefits of Baricitinib Therapy According to Scalp Hair Regrowth in Patients with Severe Alopecia Areata. Dermatol Ther (Heidelb). 2023 Dec;13(12):3209-3220. doi: 10.1007/s13555-023-01063-2. Epub 2023 Nov 22.
Ko JM, Mayo TT, Bergfeld WF, Dutronc Y, Yu G, Ball SG, Somani N, Craiglow BG. Clinical Outcomes for Uptitration of Baricitinib Therapy in Patients With Severe Alopecia Areata: A Pooled Analysis of the BRAVE-AA1 and BRAVE-AA2 Trials. JAMA Dermatol. 2023 Sep 1;159(9):970-976. doi: 10.1001/jamadermatol.2023.2581.
Piraccini BM, Ohyama M, Craiglow B, Bewley A, Ding Y, Chen YF, Dutronc Y, Pierce E, Durand F, Mostaghimi A. Scalp hair regrowth is associated with improvements in health-related quality of life and psychological symptoms in patients with severe alopecia areata: results from two randomized controlled trials. J Dermatolog Treat. 2023 Dec;34(1):2227299. doi: 10.1080/09546634.2023.2227299.
Kwon O, Senna MM, Sinclair R, Ito T, Dutronc Y, Lin CY, Yu G, Chiasserini C, McCollam J, Wu WS, King B. Efficacy and Safety of Baricitinib in Patients with Severe Alopecia Areata over 52 Weeks of Continuous Therapy in Two Phase III Trials (BRAVE-AA1 and BRAVE-AA2). Am J Clin Dermatol. 2023 May;24(3):443-451. doi: 10.1007/s40257-023-00764-w. Epub 2023 Mar 1.
King B, Mostaghimi A, Shimomura Y, Zlotogorski A, Choi GS, Blume-Peytavi U, Passeron T, Holzwarth K, Dutronc Y, McCollam J, Yang FE, Stanley S, Wu WS, Sinclair R. Integrated safety analysis of baricitinib in adults with severe alopecia areata from two randomized clinical trials. Br J Dermatol. 2023 Feb 10;188(2):218-227. doi: 10.1093/bjd/ljac059.
King B, Ohyama M, Kwon O, Zlotogorski A, Ko J, Mesinkovska NA, Hordinsky M, Dutronc Y, Wu WS, McCollam J, Chiasserini C, Yu G, Stanley S, Holzwarth K, DeLozier AM, Sinclair R; BRAVE-AA Investigators. Two Phase 3 Trials of Baricitinib for Alopecia Areata. N Engl J Med. 2022 May 5;386(18):1687-1699. doi: 10.1056/NEJMoa2110343. Epub 2022 Mar 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
Other Identifiers
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I4V-MC-JAIR
Identifier Type: OTHER
Identifier Source: secondary_id
16978
Identifier Type: -
Identifier Source: org_study_id
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