A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata
BRAVE-AA1
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
2 other identifiers
interventional
784
5 countries
75
Brief Summary
This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2018
Longer than P75 for phase_2
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2018
CompletedFirst Posted
Study publicly available on registry
June 27, 2018
CompletedStudy Start
First participant enrolled
September 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2025
CompletedResults Posted
Study results publicly available
October 1, 2025
CompletedApril 16, 2026
March 1, 2026
2.4 years
June 18, 2018
June 23, 2025
March 30, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.
Week 36
Percent Change From Baseline in SALT Score - Phase 3 Open-Label Addendum
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100, with lower score indicating better health outcomes.
Baseline, Week 52
Secondary Outcomes (15)
Percent Change From Baseline in SALT Score - Phase 3
Baseline, Week 36
Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3
Week 12
Time for Participants to Achieve SALT ≤ 20 at Week 36 - Phase 3
Week 36
Percentage of Participants Achieving Clinician Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥ 2 at Baseline) - Phase 3
Week 36
Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥ 2 at Baseline) - Phase 3
Week 36
- +10 more secondary outcomes
Study Arms (16)
Placebo Phase 2
PLACEBO COMPARATORParticipants received three placebo tablets administered orally once daily (QD). Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve Severity of Alopecia Tool (SALT) ≤20 (less than or equal to 20) during the study period.
1 Milligram (mg) / 4 mg Baricitinib Phase 2
EXPERIMENTALParticipants received one 1 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind through Week 12. Following the decision point at Week 12, participants were transitioned to receive one 4 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind, and continued treatment through Week 200.
2 mg Baricitinib Phase 2
EXPERIMENTALParticipants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
4 mg Baricitinib Phase 2
EXPERIMENTALParticipants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.
Placebo Phase 3
PLACEBO COMPARATORParticipants received two placebo tablets administered orally QD. Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve SALT≤20 during this treatment period.
2 mg Baricitinib Phase 3
EXPERIMENTALParticipants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
4 mg Baricitinib Phase 3
EXPERIMENTALParticipants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Placebo/ Placebo Phase 3
PLACEBO COMPARATORParticipants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2.
Placebo/ 2 mg Baricitinib Phase 3
EXPERIMENTALParticipants who received Placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.
Placebo/ 4 mg Baricitinib Phase 3
EXPERIMENTALParticipants who received Placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
2 mg Baricitinib /2 mg Baricitinib Phase 3
EXPERIMENTALParticipants who received 2 mg Baricitinib at Period 1 continued to receive 2 mg Baricitinib dose administered orally QD in Period 2.
2 mg Baricitinib /4 mg Baricitinib Phase 3
EXPERIMENTALParticipants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
2 mg Baricitinib / Placebo Phase 3
EXPERIMENTALParticipants who received 2 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
4 mg Baricitinib / Placebo Phase 3
EXPERIMENTALParticipants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
4 mg Baricitinib /4 mg Baricitinib Phase 3
EXPERIMENTALParticipants who received 4 mg Baricitinib at Period 1 continued to receive 4 mg Baricitinib administered orally QD in Period 2.
4 mg Baricitinib Phase 3 Open-Label Addendum
EXPERIMENTALParticipants who received one 4 mg Baricitinib tablet administered orally QD.
Interventions
Administered orally.
Administered orally.
Eligibility Criteria
You may qualify if:
- Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent.
- 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 -- Severity of Alopecia Tool (SALT) Alopecia Areata (AA) 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.
You may not qualify if:
- Primarily "diffuse" type of AA.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Incyte Corporationcollaborator
Study Sites (75)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Coastal Clinical Research, Inc
Mobile, Alabama, 36608, United States
Johnson Dermatology
Fort Smith, Arkansas, 72916, United States
California Dermatology & Clinical Research Institute
Encinitas, California, 92024, United States
Alliance Research Centers
Irvine, California, 92612, United States
University of CA, Irvine
Irvine, California, 92617, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Stanford Health Care
Redwood City, California, 94063, United States
University of California Davis-Dermatology
Sacramento, California, 95816, United States
University Clinical Trials, Inc.
San Diego, California, 92123, United States
Mosaic Dermatology
Santa Monica, California, 90403, United States
Yale University School of Medicine
New Haven, Connecticut, 06519, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, 32256, United States
University of Miami
Miami, Florida, 33125, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
ForCare Clinical Research
Tampa, Florida, 33613-1244, United States
Skin Care Physicians of Georgia
Macon, Georgia, 31217, United States
Medaphase Inc
Newnan, Georgia, 30263, United States
Northwestern University
Chicago, Illinois, 60611, United States
Forefront Research
Louisville, Kentucky, 40241, United States
Callender Center for Clinical Research, LLC / Research
Glenn Dale, Maryland, 20769, United States
ActivMed Practices and Research
Beverly, Massachusetts, 01915, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Clarkston Skin Research
Clarkston, Michigan, 48346, United States
University of Minnesota Medical School
Minneapolis, Minnesota, 55455, United States
ActivMed Practices and Research
Portsmouth, New Hampshire, 03801, United States
University of Rochester School of Medicine
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467-2490, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
OH State Univ College of Med
Gahanna, Ohio, 43230, United States
NW Dermatology & Research Center, LLC
Portland, Oregon, 97210, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
OHSU Center for Health and Healing
Portland, Oregon, 97239, United States
Dermatology and Skin Surgery Center
Exton, Pennsylvania, 19341, United States
Penn State Univ. Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Bellaire Dermatology
Bellaire, Texas, 77401, United States
Modern Research Associates
Dallas, Texas, 75231, United States
Center for Clinical Studies
Houston, Texas, 77004, United States
Austin Institute for Clinical Research
Pflugerville, Texas, 78660, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
University of Utah MidValley Dematology
Murray, Utah, 84107, United States
Dermatology Associates
Seattle, Washington, 98101, United States
Kurume University Hospital
Kurume, Fukuoka, 830 0011, Japan
Hamamatsu University School of Medicine, University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
Tokyo Medical Univ. Hospital
Shinjuku-ku, Tokyo, 160-0023, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Jalisco, 44650, Mexico
Consultorio Privado de la Dra. Villanueva
Guadalajara, Jalisco, 44657, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, N.L., 64460, Mexico
CRI Centro Regiomontano de Investigacion S.C.
Monterrey, Nuevo León, 64060, Mexico
B&B Investigaciones Medicas, SC
Mazatlán, Sinaloa, 82140, Mexico
Derma Norte del Bajío, S.C.
Aguascalientes, Mexico
RM Pharma Specialists S.A. de C.V.
Distrito Federal, 3100, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango, 34000, Mexico
Ponce School of Medicine CAIMED Center
Ponce, PR, 00716, Puerto Rico
GCM Medical Group, PSC- Hato Rey
San Juan, PR, 00917, Puerto Rico
Seoul National University Bundang Hospital
Seongnam, Geonggi-do, 13620, South Korea
Inha University Hospital
Jung-gu, Incheon, 22332, South Korea
Chonbuk National University Hospital
Jeonju, Jeon Ra Buk-Do, Korea, 54907, South Korea
Pusan National University Hospital
Busan, Korea, 49241, South Korea
Kyung Pook National University Hospital
Daegu, Korea, 41944, South Korea
Chungnam National University Hospital
Daejeon, Korea, 35015, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Eunpyeong St. Mary's Hospital
Seoul, 03312, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Kyunghee University Hospital at Gangdong
Seoul, 05278, South Korea
Chungang University Hospital
Seoul, 06973, South Korea
Related Publications (9)
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.
PMID: 40214720DERIVEDKing 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.
PMID: 39141364DERIVEDCraiglow 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.
PMID: 38904749DERIVEDSenna 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.
PMID: 37991697DERIVEDKo 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.
PMID: 37556146DERIVEDPiraccini 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.
PMID: 37381691DERIVEDKwon 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.
PMID: 36855020DERIVEDKing 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.
PMID: 36763878DERIVEDKing 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.
PMID: 35334197DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2018
First Posted
June 27, 2018
Study Start
September 24, 2018
Primary Completion
February 2, 2021
Study Completion
January 29, 2025
Last Updated
April 16, 2026
Results First Posted
October 1, 2025
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.