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

July 19, 2023 updated by: Eli Lilly and Company

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

546

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, C1027AAP
        • Centro de Investigaciones Metabólicas (CINME)
      • Buenos Aires, Argentina, C1426ABO
        • Fundacion Respirar
      • Ciudad Autonoma Buenos Aires, Argentina, C1055AA0
        • Buenos Aires Skin
      • Ciudad Autonoma Buenos Aires, Argentina, C1425BEA
        • Instituto de Neumonologia y Dermatologia
      • Mendoza, Argentina, 5500
        • Parra Dermatología
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1013AAB
        • STAT Research
    • Tucuman
      • SAN M. DE Tucuman, Tucuman, Argentina, T4000AXL
        • Centro Medico Privado de Reumatologia
      • Victoria, Australia, 3002
        • Sinclair Dermatology
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australia, 2606
        • Woden Dermatology
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Skin & Cancer Foundation Australia
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Veracity Clinical Research Pty Ltd
    • South Australia
      • Adelaide, South Australia, Australia, 5073
        • Clinical Trials SA Pty Ltd
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Skin Health Institute Inc.
    • Western Australia
      • Perth, Western Australia, Australia, 6160
        • Fremantle Dermatology
      • Rio de Janeiro, Brazil, 20241180
        • Instituto Brasil de Pesquisa Clínica - IBPCLIN
      • São Paulo, Brazil, 01221-020
        • Santa Casa Da Misericórdia De São Paulo
      • São Paulo, Brazil, 04039-901
        • Hospital de Servidor Publico Estadual
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22470-220
        • IDERJ - Instituto de Dermatologia e Estética do Brasil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
        • Irmandade Da Santa Casa de Misericordia de Porto Alegre
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13083-887
        • Faculdade de Ciências Médicas - UNICAMP
      • Santo André, Sao Paulo, Brazil, 09060-870
        • Fundação Faculdade de Medicina do ABC
    • São Paulo
      • Campinas, São Paulo, Brazil, 13060-904
        • Hospital PUC-CAMPINAS
      • Beijing, China, 100853
        • Chinese PLA General Hospital
      • Shanghai, China, 200443
        • Shanghai Dermatology Hospital
      • Tianjin, China, 300052
        • Tianjin Medical University General Hospital
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital
      • Beijing, Beijing, China, 100020
        • Beijing Chao Yang Hospital
      • Beijing, Beijing, China, 100050
        • Beijing Friendship Hospital Affiliate of Capital University
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Dermatology Hospital of Southern Medical University (Guangdong Provincial 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 First Affiliated Hospital of Xi'an Jiaotong University
    • Shan XI
      • Tai Yuan, Shan XI, China, 030001
        • 1st Affiliated Hospital of Shanxi Medical University
    • Shanghai
      • Shanghai, Shanghai, China, 20040
        • Huashan Hospital affiliated to Fudan University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's hospital
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Afula, Israel, 1834111
        • Ha'Emek Medical Center
      • Beer Sheva, Israel, 8410101
        • Soroka Medical Center
      • Haifa, Israel, 3525408
        • Rambam Medical Center
      • Jerusalem, Israel, 91220
        • Hadassah Medical Center
      • Petach Tikva, Israel, 4941492
        • Rabin Medical Center
      • Ramat Gan, Israel, 5265601
        • Sheba Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
      • Osaka, Japan, 545-8586
        • Osaka City University Hospital
      • Tokyo, Japan, 136-0075
        • Juntendo Tokyo Koto Geriatric Medical Center
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 222-0036
        • Yokohama Rosai Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Hamamatsu University School of Medicine, University Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • 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
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 07061
        • Seoul National University Boramae Medical Center
      • Seoul, Korea, Republic of, 05278
        • Kyunghee University Hospital at Gangdong
    • Chungcheongnam-do
      • Cheonan, Chungcheongnam-do, Korea, Republic of, 31116
        • Dankook University Hospital
    • Gyeonggi-do
      • Bucheon, Gyeonggi-do, Korea, Republic of, 14584
        • Soonchunhyang University Bucheon Hospital
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • Ajou University Hospital
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puerto Rico
      • Taichung City (r.o.c), Taiwan, 40201
        • Chung Shan Medical University Hospital
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10508
        • Chang Gung Memorial Hospital - Taipei
      • Taipei City, Taiwan, 10048
        • National Taiwan University Hospital
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Total Skin and Beauty Dermatology Center, PC
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Investigate MD
    • California
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology
      • Fremont, California, United States, 94538
        • Center for Dermatology Clinical Research, inc.
      • Northridge, California, United States, 91324
        • Quest Dermatology Research
      • San Francisco, California, United States, 94119
        • 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 3338
        • New Horizon Research Center
      • Tampa, Florida, United States, 33613-1244
        • Forcare Clinical Research
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Qualmedica Research, LLC
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group, LLC
      • South Bend, Indiana, United States, 46617
        • The South Bend Clinic Center for Research
    • 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
        • University of North Carolina Dermatology and Skin Cancer Cen
      • Charlotte, North Carolina, United States, 28277
        • Dermatology Specialists of Charlotte
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • 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
        • NW Dermatology & Research Center, LLC
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Center for Medical Research, LLC
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Administered orally
Administered orally
Other Names:
  • LY3009104
Experimental: 2 mg Baricitinib
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.
Administered orally
Administered orally
Other Names:
  • LY3009104
Placebo Comparator: Placebo
Participants received two placebo tablets administered orally QD to maintain the blind.
Administered orally
Experimental: 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.
Administered orally
Administered orally
Other Names:
  • LY3009104
Experimental: 2 mg Baricitinib MEE
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.
Administered orally
Other Names:
  • LY3009104
Placebo Comparator: Placebo MEE
Participants received two placebo tablets administered orally QD to maintain the blind.
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20
Time Frame: Week 36
Percentage of Participants Achieving SALT ≤ 20
Week 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time for Participants to Achieve SALT ≤ 20
Time Frame: Baseline through Week 36
Time for Participants to Achieve SALT ≤ 20
Baseline through Week 36
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score
Time Frame: Week 36
Mean Change From Baseline in HADS Anxiety Score
Week 36
Mean Change From Baseline in HADS Depression Score
Time Frame: Week 36
Mean Change From Baseline in HADS Depression Score
Week 36
Percent Change from Baseline in SALT score
Time Frame: Baseline, Week 36
Percent change from baseline in SALT score
Baseline, Week 36
Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50)
Time Frame: Week 12
Percentage of participants achieving SALT50
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
Time Frame: Week 36
Percentage of participants with 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
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)
Time Frame: Week 36
Percentage of participants achieving ClinRO measure for EB hair loss 0 or 1 with ≥2-point Improvement from Baseline (Among Participants with ClinRO Measure for EB Hair Loss ≥2 at Baseline)
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)
Time Frame: Week 36
Percentage of participants achieving ClinRO measure for EL hair loss 0 or 1 with ≥2-point Improvement from Baseline (Among Participants with ClinRO Measure for EL Hair Loss ≥2 at Baseline)
Week 36
Percentage of Participants Achieving PRO Measure for EB 0 or 1 with ≥2-point Improvement from Baseline (Among Participants with PRO Measure for EB ≥2 at Baseline)
Time Frame: Week 36
Percentage of participants achieving PRO measure for EB 0 or 1 with ≥2-point Improvement from Baseline (Among Participants with PRO Measure for EB ≥2 at Baseline)
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)
Time Frame: 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)
Week 36
Change from Baseline in Skindex-16 AA Symptoms Domain Score
Time Frame: Baseline, Week 36
Change from Baseline in Skindex-16 AA Symptoms Domain Score
Baseline, Week 36
Change from Baseline in Skindex-16 AA Emotions Domain Score
Time Frame: Baseline, Week 36
Change from Baseline in Skindex-16 AA Emotions Domain Score
Baseline, Week 36
Change from Baseline in Skindex-16 AA Functioning Domain Score
Time Frame: Baseline, Week 36
Change from Baseline in Skindex-16 AA Functioning Domain Score
Baseline, Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2019

Primary Completion (Actual)

January 24, 2021

Study Completion (Estimated)

July 29, 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)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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