A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata (BRAVE-AA2)

A Multicenter, Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata

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

Study Overview

• Status: Completed
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Placebo; Drug: Baricitinib

• Study Type: Interventional
• Enrollment (Actual): 606
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Mendoza, Argentina, 5500
    • Parra Dermatología
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1023AAB
      • Stat Research
    • Capital Federal, Buenos Aires, Argentina, 1425
      • Instituto de Neumonologia y Dermatologia
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1027
      • Centro de Investigaciones Metabólicas (CINME)
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, 1055
      • Buenos Aires Skin
  • Ciudad Autonoma Buenos Aires
    • Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, C1426ABO
      • Fundación Respirar
  • Tucumán Province
    • SAN M. de Tucuman, Tucumán Province, Argentina, T4000AXL
      • Centro de Investigaciones Médicas Tucuman
• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Woden Dermatology
  • New South Wales
    • Westmead, New South Wales, Australia, 2045
      • Skin & Cancer Foundation Australia
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research Pty Ltd
  • South Australia
    • Campbelltown, South Australia, Australia, 5073
      • Clinical Trials SA Pty Ltd
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute Inc.
    • Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Fremantle Dermatology
• Brazil
  • Rio de Janeiro, Brazil, 22241-180
    • IBPClin - Instituto Brasil de Pesquisa Clínica
  • São Paulo, Brazil, 01223-001
    • IPITEC
  • São Paulo, Brazil, 04039-901
    • Servidor Público Estadual - IAMSPE - centro de estudos urológicos
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
      • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • Rio de Janeiro
    • Rio de Janeiro, Rio de Janeiro, Brazil, 22470-220
      • IDERJ - Instituto de Dermatologia e Estética do Brasil
  • São Paulo
    • Campinas, São Paulo, Brazil, 13034-685
      • Centro de Pesquisa Sao Lucas
    • Campinas, São Paulo, Brazil, 13083-888
      • Hospital de Clínicas Da Universidade Estadual de Campinas
    • Santo André, São Paulo, Brazil, 09060-870
      • Faculdade de Medicina do ABC
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100853
      • Chinese PLA General Hospital
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing Municipality, China, 100020
      • Beijing Chao-Yang Hospital, Capital Medical University
    • Beijing, Beijing Municipality, China, 100050
      • Beijing Friendship Hospital Affiliate of Capital University
  • Guangdong
    • Guangzhou, Guangdong, China, 510018
      • Guangdong Province Dermatology Hospital
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
    • Zhenjiang, Jiangsu, China, 212000
      • Affiliated Hospital of Jiangsu University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital Affiliated to Fudan University
    • Shanghai, Shanghai Municipality, China, 200071
      • Shanghai Skin Disease Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 30001
      • First Affiliated Hospital of Shanxi Medical University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Tianjin Medical University General Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China, 310052
      • The Second Affiliated hospital of Zhejiang University school of medicine
• Israel
  • Central District
    • Petah Tikva, Central District, Israel, 4941492
      • Rabin Medical Center
    • Ramat Gan, Central District, Israel, 5262100
      • Sheba Medical Center
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 9112001
      • Hadassah Medical Center
  • Northern District
    • Afula, Northern District, Israel, 1834111
      • Emek Medical Center
    • Haifa, Northern District, Israel, 3109601
      • Rambam Medical Center
  • Southern District
    • Beersheba, Southern District, Israel, 8410101
      • Soroka Medical Center
  • Tell Abīb
    • Tel Aviv, Tell Abīb, Israel, 6423906
      • Sourasky Medical Center
• Japan
  • Osaka, Japan, 545-8586
    • Osaka City University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 222-0036
      • Yokohama Rosai Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
    • Koto-ku, Tokyo, Japan, 136-0075
      • Juntendo Tokyo Koto Geriatric Medical Center
    • Mitaka, Tokyo, Japan, 181-8611
      • Kyorin University Hospital
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Tokyo Medical Univ. Hospital
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-8505
      • Yamaguchi University Hospital
• Puerto Rico
  • San Juan, Puerto Rico, 00909
    • Clinical Research Puerto Rico
• South Korea
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Chungcheongnam-do
    • Cheonan, Chungcheongnam-do, South Korea, 31116
      • Dankook University Hospital
  • Gyeonggi-do
    • Bucheon-si, Gyeonggi-do, South Korea, 14584
      • Soonchunhyang University Bucheon Hospital
    • Suwon, Gyeonggi-do, South Korea, 16499
      • Ajou University Hospital
  • Seoul-teukbyeolsi [Seoul]
    • Dongjak-gu, Seoul-teukbyeolsi [Seoul], South Korea, 07061
      • Boramae Medical Center
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 134-090
      • Kyunghee University Hospital at Gangdong
• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taoyuan District, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch
  • Taichung
    • Taichung, Taichung, Taiwan, 402
      • Chung Shan Medical University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center, PC
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Investigate MD
  • California
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research, inc.
    • Northridge, California, United States, 91324
      • Quest Dermatology Research
    • San Francisco, California, United States, 94118
      • Kaiser Permanente Hospital
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • New England Research Associates
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Florida Academic Centers Research and Education, LLC
    • Miami, Florida, United States, 33165
      • New Horizon Research Center
    • Tampa, Florida, United States, 33613-1244
      • ForCare Clinical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
    • South Bend, Indiana, United States, 46617
      • The South Bend Clinic Center for Research
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Qualmedica Research, LLC
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Dermatology and Skin Cancer Specialists
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Inc.
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan, LLC
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Associated Skin Care Specialists
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • MediSearch Clinical Trials
  • New York
    • Troy, New York, United States, 12180
      • Joseph J. Schwartz, M.D.
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • The University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28211
      • Dermatology Specialists of Charlotte
    • Raleigh, North Carolina, United States, 27612
      • M3-Emerging Medical Research
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Bexley Dermatology Research
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Mason, Ohio, United States, 45040
      • Dermatologists of Southwest Ohio
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, P.C.
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
    • Portland, Oregon, United States, 97210
      • Northwest Dermatology Institute
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research, Providence
  • Texas
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates, PA
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time 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 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:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received two placebo tablets matched to baricitinib, administered orally once daily (QD) to maintain the blind.	Drug: Placebo; Administered orally
Experimental: 2 mg Baricitinib; Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: 4 mg Baricitinib; Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Placebo Comparator: Placebo/ Placebo; Participants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2.	Drug: Placebo; Administered orally
Experimental: Placebo/ 2-mg Baricitinib; Participants who received two placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: Placebo/ 4-mg Baricitinib; Participants who received two placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: 2-mg Baricitinib/ 2-mg Baricitinib; Participants who received 2 mg Baricitinib at Period 1 continued to receive same 2 mg Baricitinib dose administered orally QD in Period 2.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: 2-mg Baricitinib/ 4-mg Baricitinib; Participants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: 4-mg Baricitinib/ Placebo; Participants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.	Drug: Placebo; Administered orally
Experimental: 4-mg Baricitinib/ 2-mg Baricitinib; Participants who received 4 mg Baricitinib at Period 1 switched to receive 2 mg Baricitinib administered orally QD in Period 2.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: 4-mg Baricitinib/ 4-mg Baricitinib; Participants who received 4 mg Baricitinib at Period 1 continued to receive same 4 mg Baricitinib administered orally QD in Period 2.	Drug: Baricitinib; Administered orally; Other Names: LY3009104

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50)	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. SALT50 indicates at least a 50 % improvement from baseline in the SALT score.	Week 12
Percentage of Participants With Patient-Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 With a ≥2-point Improvement From Baseline Among Participants With a Score of ≥3 at Baseline	PRO is an assessment of the particpant's current extent of scalp involvement. It is comprised of 5 category response options: 0= No missing hair (0% of my scalp is missing hair; I have a full head of hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is missing hair).	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)	ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB.	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)	ClinRO measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL.	Week 36
Percentage of Participants Achieving Patient-Reported Outcome (PRO) Measure for EB 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥2 at Baseline)	PRO is an assessment of the participant's current appearance of eyebrows. It is comprised of 4 category response options: 0 = I have full EB on each eye; 1= I have a minimal gap(s) or a minimal amount of thinning in at least 1 of my EB; 2 = I have a large gap(s) or a large amount of thinning in at least 1 of my EB; and 3 = I have no or barely any EB hairs.	Week 36
Percentage of Participants Achieving PRO Measure for EL 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure EL ≥2 at Baseline)	PRO assessment of the participant's current appearance of EL. It is comprised of 4 category response options: 0 = I have full EL on each eyelid; 1 = I have a minimal gap or minimal gaps along the eyelids; 2 = I have a large gap or large gaps along the eyelids; and 3 = I have no or barely any EL hair.	Week 36
Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score	Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life. LS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors.	Baseline, Week 36
Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36	Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life. LS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors.	Baseline, Week 36
Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36	Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life. LS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors.	Baseline, Week 36
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score at Week 36	The HADS is a 14-item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (for example, 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression. LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.	Baseline, Week 36
Mean Change From Baseline in HADS Depression Score at Week 36	The HADS is a 14-item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (for example, 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression. LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.	Baseline,Week 36
Percent Change From Baseline in SALT Score at Week 36	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. 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. Least Squares Mean (LSM) was calculated using analysis of covariance (ANCOVA) with geographic region duration of current episode at baseline (< 4 years versus ≥4 years), treatment group, and baseline value in the model.	Baseline, Week 36
Time for Participants to Achieve SALT ≤ 20 at Week 36.	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. Kaplan-Meier method was used for analysis. Time for participants to achieve salt ≤ 20 at week 36 were reported in this outcome measure.	Week 36

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Incyte Corporation
• 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

General Publications

• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2019
• Primary Completion (Actual): January 24, 2021
• Study Completion (Actual): November 19, 2024

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Alopecia; Hypotrichosis; Hair Diseases; Skin and Connective Tissue Diseases; Alopecia Areata; baricitinib
• Other Study ID Numbers: 16978; I4V-MC-JAIR (Other Identifier: Eli Lilly and Company)

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 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