A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata
NCT ID: NCT03570749
Last Updated: 2025-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
764 participants
INTERVENTIONAL
2018-09-24
2025-01-29
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 Phase 2
Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) and two placebo tablets (QD) administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
2 mg Baricitinib Phase 2
Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
1 mg Baricitinib Phase 2
Participants received one 1 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Placebo Phase 2
Participants received three placebo tablets administered orally QD to maintain the blind.
Placebo
Administered orally.
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Placebo Phase 3
Participants received two placebo tablets administered orally QD.
Placebo
Administered orally.
Open-Label Addenda Baricitinib High Dose
Baricitinib will be administered orally during the open-label addenda.
Baricitinib
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
* Must self-identify as either Black or African American in race in the open label addenda.
* 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 Alopecia Areata Investigator Global Assessment (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.
* 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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University of Alabama at Birmingham
Birmingham, Alabama, United States
Coastal Clinical Research, Inc
Mobile, Alabama, United States
Johnson Dermatology
Fort Smith, Arkansas, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Alliance Research Centers
Irvine, California, United States
University of CA, Irvine
Irvine, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Stanford Health Care
Redwood City, California, United States
University of California Davis-Dermatology
Sacramento, California, United States
University Clinical Trials, Inc.
San Diego, California, United States
Mosaic Dermatology
Santa Monica, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Park Avenue Dermatology
Orange Park, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Skin Care Physicians of Georgia
Macon, Georgia, United States
Medaphase Inc
Newnan, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Forefront Research
Louisville, Kentucky, United States
Callender Center for Clinical Research, LLC / Research
Glenn Dale, Maryland, United States
ActivMed Practices and Research
Beverly, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Clarkston Skin Research
Clarkston, Michigan, United States
University of Minnesota Medical School
Minneapolis, Minnesota, United States
ActivMed Practices and Research
Portsmouth, New Hampshire, United States
University of Rochester School of Medicine
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
OH State Univ College of Med
Gahanna, Ohio, United States
NW Dermatology & Research Center, LLC
Portland, Oregon, United States
Oregon Medical Research Center
Portland, Oregon, United States
OHSU Center for Health and Healing
Portland, Oregon, United States
Dermatology and Skin Surgery Center
Exton, Pennsylvania, United States
Penn State Univ. Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Bellaire Dermatology
Bellaire, Texas, United States
Modern Research Associates
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
University of Utah MidValley Dematology
Murray, Utah, United States
Dermatology Associates
Seattle, Washington, United States
Kurume University Hospital
Kurume, Fukuoka, Japan
Hamamatsu University School of Medicine, University Hospital
Hamamatsu, Shizuoka, Japan
Tokyo Medical Univ. Hospital
Shinjuku-ku, Tokyo, Japan
Osaka City University Hospital
Osaka, , Japan
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Jalisco, Mexico
Consultorio Privado de la Dra. Villanueva
Guadalajara, Jalisco, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, N.L., Mexico
CRI Centro Regiomontano de Investigacion S.C.
Monterrey, Nuevo León, Mexico
B&B Investigaciones Medicas, SC
Mazatlán, Sinaloa, Mexico
Derma Norte del Bajío, S.C.
Aguascalientes, , Mexico
RM Pharma Specialists S.A. de C.V.
Distrito Federal, , Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango, , Mexico
Ponce School of Medicine CAIMED Center
Ponce, PR, Puerto Rico
GCM Medical Group, PSC- Hato Rey
San Juan, PR, Puerto Rico
Seoul National University Bundang Hospital
Seongnam, Geonggi-do, South Korea
Inha University Hospital
Jung-gu, Incheon, South Korea
Chonbuk National University Hospital
Jeonju, Jeon Ra Buk-Do, Korea, South Korea
Pusan National University Hospital
Busan, Korea, South Korea
Kyung Pook National University Hospital
Daegu, Korea, South Korea
Chungnam National University Hospital
Daejeon, Korea, South Korea
Seoul National University Hospital
Seoul, , South Korea
Eunpyeong St. Mary's Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Kyunghee University Hospital at Gangdong
Seoul, , South Korea
Chungang University Hospital
Seoul, , South Korea
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.
King B, Ko J, Kwon O, Vano-Galvan S, Piraccini BM, Dutronc Y, Yu G, Liu C, Somani N, Ball S, Mesinkovska NA. Baricitinib Withdrawal and Retreatment in Patients With Severe Alopecia Areata: The BRAVE-AA1 Randomized Clinical Trial. JAMA Dermatol. 2024 Oct 1;160(10):1075-1081. doi: 10.1001/jamadermatol.2024.2734.
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 Participants With Severe or Very Severe Alopecia Areata (Hair Loss)
Other Identifiers
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I4V-MC-JAHO
Identifier Type: OTHER
Identifier Source: secondary_id
16582
Identifier Type: -
Identifier Source: org_study_id
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