search
Back to results

A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata (BRAVE-AA1)

Primary Purpose

Alopecia Areata

Status
Recruiting
Phase
Phase 2
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

  • University of Alabama at BirminghamRecruiting
  • Coastal Clinical Research, Inc
  • Johnson Dermatology
  • California Dermatology & Clinical Research InstituteRecruiting
  • Alliance Research Centers
  • University of CA, Irvine
  • Dermatology Research AssociatesRecruiting
  • Stanford Medicine Outpatient CenterRecruiting
  • University of California Davis-Dermatology
  • University Clinical Trials, Inc.
  • Mosaic Dermatology
  • Yale University School of MedicineRecruiting
  • Solutions Through Advanced Research, Inc.
  • University of Miami Miller School of MedicineRecruiting
  • Park Avenue Dermatology
  • ForCare Clinical ResearchRecruiting
  • Skin Care Physicians of Georgia
  • Medaphase Inc
  • Northwestern University
  • DS ResearchRecruiting
  • Callender Center For Clinical ResearchRecruiting
  • ActivMed Practices and Research
  • Massachusetts General Hospital
  • Brigham and Women's HospitalRecruiting
  • Clarkston Skin Research
  • M Health Fairview University of Minnesota Medical Center - East BankRecruiting
  • ActivMed Practices & Research, Inc.Recruiting
  • Montefiore Medical Center
  • University of Rochester School of Medicine
  • University Hospitals Cleveland Medical Center
  • Cleveland Clinic Foundation
  • Ohio State UniversityRecruiting
  • Northwest Dermatology InstituteRecruiting
  • Oregon Medical Research Center
  • OHSU Center for Health and Healing
  • The Pennsylvania Centre for Dermatology, LLCRecruiting
  • Penn State Univ. Milton S. Hershey Medical Center
  • Penn Medicine: University of Pennsylvania Health SystemRecruiting
  • University of Pittsburgh Medical Center
  • Dermatology Associates of Plymouth Meeting
  • Medical University of South CarolinaRecruiting
  • Bellaire Dermatology
  • Modern Research Associates
  • Center for Clinical StudiesRecruiting
  • Austin Institute for Clinical ResearchRecruiting
  • Texas Dermatology and Laser Specialists
  • Dermatology Clinical Research Center of San Antonio
  • Center for Clinical Studies, LTD.LLPRecruiting
  • University of Utah MidValley Dematology
  • Dermatology Associates
  • Kurume University Hospital
  • Hamamatsu University School of Medicine, University Hospital
  • Tokyo Medical Univ. Hospital
  • Osaka City University Hospital
  • Seoul National University Bundang Hospital
  • Inha University Hospital
  • Chonbuk National University Hospital
  • Pusan National University Hospital
  • Kyung Pook National University Hospital
  • Chungnam National University Hospital
  • Seoul National University Hospital
  • Eunpyeong St. Mary's Hospital
  • Konkuk University Medical Center
  • Kyunghee University Hospital at Gangdong
  • Chungang University Hospital
  • Clinica de Investigacion en Reumatologia y Obesidad S. C.
  • Consultorio Privado de la Dra. Villanueva
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • CRI Centro Regiomontano de Investigacion S.C.
  • B&B Investigaciones Medicas, SC
  • Derma Norte del Bajío, S.C.
  • RM Pharma Specialists S.A. de C.V.
  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C
  • Ponce School of Medicine CAIMED Center
  • GCM Medical Group, PSC- Hato Rey

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Baricitinib High Dose

Baricitinib Low Dose

Placebo

Open-Label Addenda Baricitinib High Dose

Arm Description

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

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

Participants administered orally.

Baricitinib will be administered orally during the open-label addenda.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Participants Achieving 50% Improvement of SALT (SALT50)
Percentage of participants achieving SALT50
Percent Change from Baseline in SALT Score
Percent change from baseline in SALT score
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 Eye Lash (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 Patient Reported Outcome (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)
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
June 18, 2018
Last Updated
October 19, 2023
Sponsor
Eli Lilly and Company
Collaborators
Incyte Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT03570749
Brief Title
A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata
Acronym
BRAVE-AA1
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 24, 2018 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
January 26, 2025 (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
This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.

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 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
824 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baricitinib High Dose
Arm Type
Experimental
Arm Description
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Arm Title
Baricitinib Low Dose
Arm Type
Experimental
Arm Description
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants administered orally.
Arm Title
Open-Label Addenda Baricitinib High Dose
Arm Type
Experimental
Arm Description
Baricitinib will be administered orally during the open-label addenda.
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
Percentage of Participants Achieving 50% Improvement of SALT (SALT50)
Description
Percentage of participants achieving SALT50
Time Frame
Week 12
Title
Percent Change from Baseline in SALT Score
Description
Percent change from baseline in SALT score
Time Frame
Baseline, 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 Eye Lash (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 Patient Reported Outcome (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
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. Must self-identify as either Black or African American in race in the open label addenda. Have severe or very severe AA, as determined by all of the following: Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured by SALT Alopecia Areata Investigator Global Assessment (AA-IGA) of 3 or 4) at screening and baseline. No spontaneous improvement over the past 6 months. Current episode of severe or very severe AA of less than 8 years. Male or nonpregnant, nonbreastfeeding female participants. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
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
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
205-502-9960
First Name & Middle Initial & Last Name & Degree
Tiffany Mayo
Facility Name
Coastal Clinical Research, Inc
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Johnson Dermatology
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
760-203-3839
First Name & Middle Initial & Last Name & Degree
Stacy R. Smith
Facility Name
Alliance Research Centers
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of CA, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92617
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
310-337-7171
First Name & Middle Initial & Last Name & Degree
Howard Sofen
Facility Name
Stanford Medicine Outpatient Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
650-721-7167
First Name & Middle Initial & Last Name & Degree
Justin Ko
Facility Name
University of California Davis-Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University Clinical Trials, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mosaic Dermatology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
203-577-1050
First Name & Middle Initial & Last Name & Degree
Brett A King
Facility Name
Solutions Through Advanced Research, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
305-243-8205
First Name & Middle Initial & Last Name & Degree
Antonella Tosti
Facility Name
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
813-960-2400
First Name & Middle Initial & Last Name & Degree
Seth Forman
Facility Name
Skin Care Physicians of Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medaphase Inc
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
DS Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
502-585-9059
First Name & Middle Initial & Last Name & Degree
Cindy E Owen
Facility Name
Callender Center For Clinical Research
City
Glenn Dale
State/Province
Maryland
ZIP/Postal Code
20769
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
301-249-0970
First Name & Middle Initial & Last Name & Degree
Valerie Callender
Facility Name
ActivMed Practices and Research
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
617-525-8335
First Name & Middle Initial & Last Name & Degree
Arash Mostaghimi
Facility Name
Clarkston Skin Research
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
M Health Fairview University of Minnesota Medical Center - East Bank
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
612-625-6118
First Name & Middle Initial & Last Name & Degree
Maria K Hordinsky
Facility Name
ActivMed Practices & Research, Inc.
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
603-319-8863
First Name & Middle Initial & Last Name & Degree
Abel Jarell
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2490
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Rochester School of Medicine
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Ohio State University
City
Gahanna
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
614-366-9201
First Name & Middle Initial & Last Name & Degree
Jessica Kaffenberger
Facility Name
Northwest Dermatology Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
503-223-1933
First Name & Middle Initial & Last Name & Degree
Nisha Desai
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
OHSU Center for Health and Healing
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The Pennsylvania Centre for Dermatology, LLC
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
610-594-6660
First Name & Middle Initial & Last Name & Degree
Scott L Gottlieb
Facility Name
Penn State Univ. Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Penn Medicine: University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
215-615-2934
First Name & Middle Initial & Last Name & Degree
Susan Taylor
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dermatology Associates of Plymouth Meeting
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
843-792-5858
First Name & Middle Initial & Last Name & Degree
Lara Wine Lee
Facility Name
Bellaire Dermatology
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Modern Research Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
7135288818
First Name & Middle Initial & Last Name & Degree
Stephen Keith Tyring
Facility Name
Austin Institute for Clinical Research
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
512-279-2545
First Name & Middle Initial & Last Name & Degree
Edward Lain
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Center for Clinical Studies, LTD.LLP
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
281-333-2288
First Name & Middle Initial & Last Name & Degree
PATRICIA LEE
Facility Name
University of Utah MidValley Dematology
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dermatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830 0011
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Hamamatsu University School of Medicine, University Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tokyo Medical Univ. Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Geonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Inha University Hospital
City
Junggu
State/Province
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Chonbuk National University Hospital
City
Jeonju
State/Province
Jeon Ra Buk-Do, Korea
ZIP/Postal Code
54907
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Pusan National University Hospital
City
Busan
State/Province
Korea
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Kyung Pook National University Hospital
City
Daegu
State/Province
Korea
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Chungnam National University Hospital
City
Daejeon
State/Province
Korea
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Eunpyeong St. Mary's Hospital
City
Seoul
ZIP/Postal Code
03312
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Kyunghee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Chungang University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Clinica de Investigacion en Reumatologia y Obesidad S. C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Consultorio Privado de la Dra. Villanueva
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44657
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
State/Province
N.l.
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
CRI Centro Regiomontano de Investigacion S.C.
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64060
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
B&B Investigaciones Medicas, SC
City
Mazatlan
State/Province
Sinaloa
ZIP/Postal Code
82140
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Derma Norte del Bajío, S.C.
City
Aguascalientes
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
RM Pharma Specialists S.A. de C.V.
City
Distrito Federal
ZIP/Postal Code
3100
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Ponce School of Medicine CAIMED Center
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Individual Site Status
Active, not recruiting
Facility Name
GCM Medical Group, PSC- Hato Rey
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Individual Site Status
Active, not recruiting

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 European Union (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/74jaQin8Q0aiIE2iaE2sCu
Description
A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata (Hair Loss)

Learn more about this trial

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

We'll reach out to this number within 24 hrs