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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03899259
Collaborator
Incyte Corporation (Industry)
546
Enrollment
98
Locations
3
Arms
58.6
Anticipated Duration (Months)
5.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
546 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 8, 2019
Actual Primary Completion Date :
Jan 24, 2021
Anticipated Study Completion Date :
May 27, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Baricitinib High Dose

Baricitinib administered orally. Placebo administered orally to maintain the blind.

Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104

    • Drug: Placebo
    Administered orally
    Experimental: Baricitinib Low Dose

    Baricitinib administered orally. Placebo administered orally to maintain the blind.

    Drug: Baricitinib
    Administered orally
    Other Names:
  • LY3009104

    • Drug: Placebo
    Administered orally
    Placebo Comparator: Placebo

    Placebo administered orally.

    Drug: Placebo
    Administered orally

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [Week 36]

      Percentage of Participants Achieving SALT ≤ 20

    Secondary Outcome Measures

    1. Percent Change from Baseline in SALT score [Baseline, Week 36]

      Percent change from baseline in SALT score

    2. Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) [Week 12]

      Percentage of participants achieving SALT50

    3. 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 [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

    4. Time for Participants to Achieve SALT ≤ 20 [Baseline through Week 36]

      Time for Participants to Achieve SALT ≤ 20

    5. 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) [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)

    6. 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) [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)

    7. 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 EB 0 or 1 with ≥2-point Improvement from Baseline (Among Participants with PRO Measure for EB ≥2 at Baseline)

    8. 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]

      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)

    9. Change from Baseline in Skindex-16 AA Symptoms Domain Score [Baseline, Week 36]

      Change from Baseline in Skindex-16 AA Symptoms Domain Score

    10. Change from Baseline in Skindex-16 AA Emotions Domain Score [Baseline, Week 36]

      Change from Baseline in Skindex-16 AA Emotions Domain Score

    11. Change from Baseline in Skindex-16 AA Functioning Domain Score [Baseline, Week 36]

      Change from Baseline in Skindex-16 AA Functioning Domain Score

    12. Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score [Week 36]

      Mean Change From Baseline in HADS Anxiety Score

    13. Mean Change From Baseline in HADS Depression Score [Week 36]

      Mean Change From Baseline in HADS Depression Score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Total Skin and Beauty Dermatology Center, PC Birmingham Alabama United States 35205
    2 Investigate MD Scottsdale Arizona United States 85255
    3 First OC Dermatology Fountain Valley California United States 92708
    4 Center For Dermatology Clinical Research, Inc. Fremont California United States 94538
    5 Quest Dermatology Research Northridge California United States 91324
    6 Kaiser Permanente Hospital San Francisco California United States 94119
    7 New England Research Associates Bridgeport Connecticut United States 06606
    8 Florida Academic Centers Research and Education, LLC Coral Gables Florida United States 33134
    9 New Horizon Research Center Miami Florida United States 33165 3338
    10 ForCare Clinical Research Tampa Florida United States 33613-1244
    11 Qualmedica Research, LLC Evansville Indiana United States 47715
    12 Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana United States 46250
    13 The South Bend Clinic Center for Research South Bend Indiana United States 46617
    14 Dermatology and Skin Cancer Specialists Rockville Maryland United States 20850
    15 Tufts Medical Center Boston Massachusetts United States 02111
    16 Great Lakes Research Group, Inc. Bay City Michigan United States 48706
    17 Clinical Research Institute of Michigan, LLC Chesterfield Michigan United States 48047
    18 Hamzavi Dermatology Fort Gratiot Michigan United States 48059
    19 Associated Skin Care Specialists New Brighton Minnesota United States 55112
    20 MediSearch Clinical Trials Saint Joseph Missouri United States 64506
    21 Joseph J. Schwartz, M.D. Troy New York United States 12180
    22 University of North Carolina Dermatology and Skin Cancer Cen Chapel Hill North Carolina United States 27516
    23 Dermatology Specialists of Charlotte Charlotte North Carolina United States 28277
    24 Wake Research Associates Raleigh North Carolina United States 27612
    25 Bexley Dermatology Research Bexley Ohio United States 43209
    26 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    27 Dermatologists of Southwest Ohio Mason Ohio United States 45040
    28 Vital Prospects Clinical Research Institute, P.C. Tulsa Oklahoma United States 74136
    29 NW Dermatology & Research Center, LLC Portland Oregon United States 97210
    30 Oregon Dermatology and Research Center Portland Oregon United States 97210
    31 Center for Medical Research, LLC Providence Rhode Island United States 02908
    32 Omega Medical Research Warwick Rhode Island United States 02886
    33 Suzanne Bruce and Associates, PA Houston Texas United States 77056
    34 Progressive Clinical Research San Antonio Texas United States 78213
    35 Virginia Clinical Research, Inc. Norfolk Virginia United States 23502
    36 Stat Research Caba Buenos Aires Argentina C1013AAB
    37 Centro Medico Privado de Reumatologia SAN M. DE Tucuman Tucuman Argentina T4000AXL
    38 Centro de Investigaciones Metabólicas (CINME) Buenos Aires Argentina C1027AAP
    39 Fundacion Respirar Buenos Aires Argentina C1426ABO
    40 Buenos Aires Skin Ciudad Autonoma Buenos Aires Argentina C1055AA0
    41 Instituto de Neumonología y Dermatología Ciudad Autonoma Buenos Aires Argentina C1425BEA
    42 Parra Dermatología Mendoza Argentina 5500
    43 Woden Dermatology Phillip Australian Capital Territory Australia 2606
    44 Skin & Cancer Foundation Australia Westmead New South Wales Australia 2145
    45 Veracity Clinical Research Pty Ltd Woolloongabba Queensland Australia 4102
    46 Clinical Trials SA Pty Ltd Adelaide South Australia Australia 5073
    47 Skin Health Institute Inc. Carlton Victoria Australia 3053
    48 Fremantle Dermatology Perth Western Australia Australia 6160
    49 Sinclair Dermatology Victoria Australia 3002
    50 Irmandade da Santa Casa de Misericordia de Porto Alegre Porto Alegre Rio Grande Do Sul Brazil 90020-090
    51 IDERJ - Instituto de Dermatologia e Estética do Brasil Rio de Janeiro RJ Brazil 22470-220
    52 Faculdade de Ciências Médicas - UNICAMP Campinas Sao Paulo Brazil 13083-887
    53 Fundação Faculdade de Medicina do ABC Santo André Sao Paulo Brazil 09060-870
    54 Hospital PUC-CAMPINAS Campinas São Paulo Brazil 13060-904
    55 Instituto Brasil de Pesquisa Clínica - IBPCLIN Rio de Janeiro Brazil 20241180
    56 Santa Casa Da Misericórdia De São Paulo São Paulo Brazil 01221-020
    57 Hospital de Servidor Publico Estadual São Paulo Brazil 04039-901
    58 Beijing Chao Yang Hospital Beijing Beijing China 100020
    59 Beijing Friendship Hospital Affiliate of Capital University Beijing Beijing China 100050
    60 Peking University Third Hospital Beijing Beijing China 100191
    61 Dermatology Hospital of Southern Medical University (Guangdong Provincial Dermatology Hospital) Guangzhou Guangdong China 510000
    62 Xiangya Hospital Central South University Changsha Hunan China 410008
    63 Jiangsu Province Hospital Nanjing Jiangsu China 210029
    64 Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu China 212000
    65 The First Affiliated Hospital of Xi'an Jiaotong University Xi'An Shaanxi China 710004
    66 1st affiliated Hospital of Shanxi Medical University Tai Yuan Shan XI China 030001
    67 HuaShan Hospital Affiliated To Fudan University Shanghai Shanghai China 20040
    68 The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 310009
    69 Zhejiang Provincial People's Hospital Hangzhou Zhejiang China 310014
    70 Chinese PLA General Hospital Beijing China 100853
    71 Shanghai Dermatology Hospital Shanghai China 200443
    72 Tianjin Medical University General Hospital Tianjin China 300052
    73 Ha'Emek Medical Center Afula Israel 1834111
    74 Soroka Medical Center Beer Sheva Israel 8410101
    75 Rambam Medical Center Haifa Israel 3525408
    76 Hadassah Medical Center Jerusalem Israel 91220
    77 Rabin Medical Center Petach Tikva Israel 4941492
    78 Sheba Medical Center Ramat Gan Israel 5265601
    79 Tel Aviv Sourasky Medical Center Tel Aviv Israel 6423906
    80 Yokohama Rosai Hospital Yokohama Kanagawa Japan 222-0036
    81 Hamamatsu University School of Medicine, University Hospital Hamamatsu Shizuoka Japan 431-3192
    82 Juntendo University Hospital Bunkyo-ku Tokyo Japan 113-8431
    83 Kyorin University Hospital Mitaka Tokyo Japan 181-8611
    84 Tokyo Medical Univ. Hospital Shinjuku-ku Tokyo Japan 160-0023
    85 Yamaguchi University Hospital Ube Yamaguchi Japan 755-8505
    86 Osaka City University Hospital Osaka Japan 545-8586
    87 Juntendo Tokyo Koto Geriatric Medical Center Tokyo Japan 136-0075
    88 Dankook University Hospital Cheonan Chungcheongnam-do Korea, Republic of 31116
    89 Soonchunhyang University Bucheon Hospital Bucheon Gyeonggi-do Korea, Republic of 14584
    90 Ajou University Hospital Suwon Gyeonggi-do Korea, Republic of 16499
    91 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    92 Kyunghee University Hospital at Gangdong Seoul Korea, Republic of 05278
    93 Seoul National University Boramae Medical Center Seoul Korea, Republic of 07061
    94 Clinical Research Puerto Rico San Juan Puerto Rico 00909
    95 Chung Shan Medical University Hospital Taichung City (r.o.c) Taiwan 40201
    96 National Cheng Kung University Hospital Tainan Taiwan 70403
    97 National Taiwan University Hospital Taipei City Taiwan 10048
    98 Chang Gung Memorial Hospital - Taipei Taipei Taiwan 10508

    Sponsors and Collaborators

    • Eli Lilly and Company
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03899259
    Other Study ID Numbers:
    • 16978
    • I4V-MC-JAIR
    First Posted:
    Apr 2, 2019
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alopecia
    Alopecia Areata

    Study Results

    No Results Posted as of Jan 26, 2022