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

Primary Purpose

Alopecia Areata

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Baricitinib
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Total Skin and Beauty Dermatology Center, PC
  • Investigate MD
  • First OC Dermatology
  • Center For Dermatology Clinical Research, Inc.
  • Quest Dermatology Research
  • Kaiser Permanente Hospital
  • New England Research Associates
  • Florida Academic Centers Research and Education, LLC
  • New Horizon Research Center
  • ForCare Clinical Research
  • Qualmedica Research, LLC
  • Dawes Fretzin Clinical Research Group, LLC
  • The South Bend Clinic Center for Research
  • Dermatology and Skin Cancer Specialists
  • Tufts Medical Center
  • Great Lakes Research Group, Inc.
  • Clinical Research Institute of Michigan, LLC
  • Hamzavi Dermatology
  • Associated Skin Care Specialists
  • MediSearch Clinical Trials
  • Joseph J. Schwartz, M.D.
  • University of North Carolina Dermatology and Skin Cancer Cen
  • Dermatology Specialists of Charlotte
  • Wake Research Associates
  • Bexley Dermatology Research
  • University Hospitals Cleveland Medical Center
  • Dermatologists of Southwest Ohio
  • Vital Prospects Clinical Research Institute, P.C.
  • NW Dermatology & Research Center, LLC
  • Oregon Dermatology and Research Center
  • Center for Medical Research, LLC
  • Omega Medical Research
  • Suzanne Bruce and Associates, PA
  • Progressive Clinical Research
  • Virginia Clinical Research, Inc.
  • Stat Research
  • Centro Medico Privado de Reumatologia
  • Centro de Investigaciones Metabólicas (CINME)
  • Fundacion Respirar
  • Buenos Aires Skin
  • Instituto de Neumonología y Dermatología
  • Parra Dermatología
  • Woden Dermatology
  • Skin & Cancer Foundation Australia
  • Veracity Clinical Research Pty Ltd
  • Clinical Trials SA Pty Ltd
  • Skin Health Institute Inc.
  • Fremantle Dermatology
  • Sinclair Dermatology
  • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • IDERJ - Instituto de Dermatologia e Estética do Brasil
  • Faculdade de Ciências Médicas - UNICAMP
  • Fundação Faculdade de Medicina do ABC
  • Hospital PUC-CAMPINAS
  • Instituto Brasil de Pesquisa Clínica - IBPCLIN
  • Santa Casa Da Misericórdia De São Paulo
  • Hospital de Servidor Publico Estadual
  • Beijing Chao Yang Hospital
  • Beijing Friendship Hospital Affiliate of Capital University
  • Peking University Third Hospital
  • Dermatology Hospital of Southern Medical University (Guangdong Provincial Dermatology Hospital)
  • Xiangya Hospital Central South University
  • Jiangsu Province Hospital
  • Affiliated Hospital of Jiangsu University
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • 1st affiliated Hospital of Shanxi Medical University
  • HuaShan Hospital Affiliated To Fudan University
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Zhejiang Provincial People's Hospital
  • Chinese PLA General Hospital
  • Shanghai Dermatology Hospital
  • Tianjin Medical University General Hospital
  • Ha'Emek Medical Center
  • Soroka Medical Center
  • Rambam Medical Center
  • Hadassah Medical Center
  • Rabin Medical Center
  • Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • Yokohama Rosai Hospital
  • Hamamatsu University School of Medicine, University Hospital
  • Juntendo University Hospital
  • Kyorin University Hospital
  • Tokyo Medical Univ. Hospital
  • Yamaguchi University Hospital
  • Osaka City University Hospital
  • Juntendo Tokyo Koto Geriatric Medical Center
  • Dankook University Hospital
  • Soonchunhyang University Bucheon Hospital
  • Ajou University Hospital
  • Severance Hospital, Yonsei University Health System
  • Kyunghee University Hospital at Gangdong
  • Seoul National University Boramae Medical Center
  • Clinical Research Puerto Rico
  • Chung Shan Medical University Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital - Taipei

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

4 Milligram (mg) Baricitinib

2 mg Baricitinib

Placebo

4 mg Baricitinib Maximum Extended Enrollment (MEE)

2 mg Baricitinib MEE

Placebo MEE

Arm Description

Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.

Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.

Participants received two placebo tablets administered orally QD to maintain the blind.

Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.

Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.

Participants received two placebo tablets administered orally QD to maintain the blind.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20
Percentage of Participants Achieving SALT ≤ 20

Secondary Outcome Measures

Percent Change from Baseline in SALT score
Percent change from baseline in SALT score
Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50)
Percentage of participants achieving SALT50
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
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
Time for Participants to Achieve SALT ≤ 20
Time for Participants to Achieve SALT ≤ 20
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)
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)
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)
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)
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)
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)
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)
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)
Change from Baseline in Skindex-16 AA Symptoms Domain Score
Change from Baseline in Skindex-16 AA Symptoms Domain Score
Change from Baseline in Skindex-16 AA Emotions Domain Score
Change from Baseline in Skindex-16 AA Emotions Domain Score
Change from Baseline in Skindex-16 AA Functioning Domain Score
Change from Baseline in Skindex-16 AA Functioning Domain Score
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score
Mean Change From Baseline in HADS Anxiety Score
Mean Change From Baseline in HADS Depression Score
Mean Change From Baseline in HADS Depression Score

Full Information

First Posted
April 1, 2019
Last Updated
July 19, 2023
Sponsor
Eli Lilly and Company
Collaborators
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03899259
Brief Title
A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
Acronym
BRAVE-AA2
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
January 24, 2021 (Actual)
Study Completion Date
July 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
546 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4 Milligram (mg) Baricitinib
Arm Type
Experimental
Arm Description
Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.
Arm Title
2 mg Baricitinib
Arm Type
Experimental
Arm Description
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received two placebo tablets administered orally QD to maintain the blind.
Arm Title
4 mg Baricitinib Maximum Extended Enrollment (MEE)
Arm Type
Experimental
Arm Description
Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.
Arm Title
2 mg Baricitinib MEE
Arm Type
Experimental
Arm Description
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.
Arm Title
Placebo MEE
Arm Type
Placebo Comparator
Arm Description
Participants received two placebo tablets administered orally QD to maintain the blind.
Intervention Type
Drug
Intervention Name(s)
Baricitinib
Other Intervention Name(s)
LY3009104
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20
Description
Percentage of Participants Achieving SALT ≤ 20
Time Frame
Week 36
Secondary Outcome Measure Information:
Title
Percent Change from Baseline in SALT score
Description
Percent change from baseline in SALT score
Time Frame
Baseline, Week 36
Title
Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50)
Description
Percentage of participants achieving SALT50
Time Frame
Week 12
Title
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
Description
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
Time Frame
Week 36
Title
Time for Participants to Achieve SALT ≤ 20
Description
Time for Participants to Achieve SALT ≤ 20
Time Frame
Baseline through Week 36
Title
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)
Description
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)
Time Frame
Week 36
Title
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)
Description
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)
Time Frame
Week 36
Title
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)
Description
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
Title
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)
Description
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
Title
Change from Baseline in Skindex-16 AA Symptoms Domain Score
Description
Change from Baseline in Skindex-16 AA Symptoms Domain Score
Time Frame
Baseline, Week 36
Title
Change from Baseline in Skindex-16 AA Emotions Domain Score
Description
Change from Baseline in Skindex-16 AA Emotions Domain Score
Time Frame
Baseline, Week 36
Title
Change from Baseline in Skindex-16 AA Functioning Domain Score
Description
Change from Baseline in Skindex-16 AA Functioning Domain Score
Time Frame
Baseline, Week 36
Title
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score
Description
Mean Change From Baseline in HADS Anxiety Score
Time Frame
Week 36
Title
Mean Change From Baseline in HADS Depression Score
Description
Mean Change From Baseline in HADS Depression Score
Time Frame
Week 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Total Skin and Beauty Dermatology Center, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Investigate MD
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Center For Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Quest Dermatology Research
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Kaiser Permanente Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94119
Country
United States
Facility Name
New England Research Associates
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Florida Academic Centers Research and Education, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165 3338
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
Qualmedica Research, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
The South Bend Clinic Center for Research
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Dermatology and Skin Cancer Specialists
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Associated Skin Care Specialists
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Joseph J. Schwartz, M.D.
City
Troy
State/Province
New York
ZIP/Postal Code
12180
Country
United States
Facility Name
University of North Carolina Dermatology and Skin Cancer Cen
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Facility Name
Dermatology Specialists of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Bexley Dermatology Research
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Dermatologists of Southwest Ohio
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, P.C.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
NW Dermatology & Research Center, LLC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Center for Medical Research, LLC
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Suzanne Bruce and Associates, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Stat Research
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1013AAB
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia
City
SAN M. DE Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
Buenos Aires
ZIP/Postal Code
C1027AAP
Country
Argentina
Facility Name
Fundacion Respirar
City
Buenos Aires
ZIP/Postal Code
C1426ABO
Country
Argentina
Facility Name
Buenos Aires Skin
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1055AA0
Country
Argentina
Facility Name
Instituto de Neumonología y Dermatología
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1425BEA
Country
Argentina
Facility Name
Parra Dermatología
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Woden Dermatology
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
Skin & Cancer Foundation Australia
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Veracity Clinical Research Pty Ltd
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Clinical Trials SA Pty Ltd
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5073
Country
Australia
Facility Name
Skin Health Institute Inc.
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Fremantle Dermatology
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Sinclair Dermatology
City
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Irmandade da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
IDERJ - Instituto de Dermatologia e Estética do Brasil
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22470-220
Country
Brazil
Facility Name
Faculdade de Ciências Médicas - UNICAMP
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13083-887
Country
Brazil
Facility Name
Fundação Faculdade de Medicina do ABC
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Hospital PUC-CAMPINAS
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
Instituto Brasil de Pesquisa Clínica - IBPCLIN
City
Rio de Janeiro
ZIP/Postal Code
20241180
Country
Brazil
Facility Name
Santa Casa Da Misericórdia De São Paulo
City
São Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
Hospital de Servidor Publico Estadual
City
São Paulo
ZIP/Postal Code
04039-901
Country
Brazil
Facility Name
Beijing Chao Yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Beijing Friendship Hospital Affiliate of Capital University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Dermatology Hospital of Southern Medical University (Guangdong Provincial Dermatology Hospital)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212000
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'An
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Facility Name
1st affiliated Hospital of Shanxi Medical University
City
Tai Yuan
State/Province
Shan XI
ZIP/Postal Code
030001
Country
China
Facility Name
HuaShan Hospital Affiliated To Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20040
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Shanghai Dermatology Hospital
City
Shanghai
ZIP/Postal Code
200443
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Ha'Emek Medical Center
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Soroka Medical Center
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3525408
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91220
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Yokohama Rosai Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan
Facility Name
Hamamatsu University School of Medicine, University Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Tokyo Medical Univ. Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Juntendo Tokyo Koto Geriatric Medical Center
City
Tokyo
ZIP/Postal Code
136-0075
Country
Japan
Facility Name
Dankook University Hospital
City
Cheonan
State/Province
Chungcheongnam-do
ZIP/Postal Code
31116
Country
Korea, Republic of
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
State/Province
Gyeonggi-do
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Kyunghee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Clinical Research Puerto Rico
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Chung Shan Medical University Hospital
City
Taichung City (r.o.c)
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Taipei
City
Taipei
ZIP/Postal Code
10508
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/
Citations:
PubMed Identifier
35334197
Citation
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.
Results Reference
derived
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/10fuouLYVPNjWekNxnfJoE
Description
A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata

Learn more about this trial

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

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