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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03899259




Registration number
NCT03899259
Ethics application status
Date submitted
1/04/2019
Date registered
2/04/2019

Titles & IDs
Public title
A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
Scientific 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
Secondary ID [1] 0 0
I4V-MC-JAIR
Secondary ID [2] 0 0
16978
Universal Trial Number (UTN)
Trial acronym
BRAVE-AA2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alopecia Areata 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Baricitinib
Treatment: Drugs - Placebo

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.

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

Placebo comparator: Placebo - Participants received two placebo tablets administered orally QD to maintain the blind.

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.

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.

Placebo comparator: Placebo MEE - Participants received two placebo tablets administered orally QD to maintain the blind.


Treatment: Drugs: Baricitinib
Administered orally

Treatment: Drugs: Placebo
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) = 20
Timepoint [1] 0 0
Week 36
Secondary outcome [1] 0 0
Percent Change From Baseline in SALT Score at Week 36
Timepoint [1] 0 0
Baseline, Week 36
Secondary outcome [2] 0 0
Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50)
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Week 36
Secondary outcome [4] 0 0
Time for Participants to Achieve SALT = 20
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
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)
Timepoint [5] 0 0
Week 36
Secondary outcome [6] 0 0
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)
Timepoint [6] 0 0
Week 36
Secondary outcome [7] 0 0
Percentage of Participants Achieving Patient-Reported Outcome (PRO) Measure for EB 0 or 1 With =2-point Improvement From Baseline (Among Participants With PRO Measure for EB =2 at Baseline)
Timepoint [7] 0 0
Week 36
Secondary outcome [8] 0 0
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)
Timepoint [8] 0 0
Week 36
Secondary outcome [9] 0 0
Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score
Timepoint [9] 0 0
Baseline, Week 36
Secondary outcome [10] 0 0
Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36
Timepoint [10] 0 0
Baseline, Week 36
Secondary outcome [11] 0 0
Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36
Timepoint [11] 0 0
Baseline, Week 36
Secondary outcome [12] 0 0
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score at Week 36
Timepoint [12] 0 0
Baseline, Week 36
Secondary outcome [13] 0 0
Mean Change From Baseline in HADS Depression Score at Week 36
Timepoint [13] 0 0
Baseline,Week 36

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
546
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Woden Dermatology - Phillip
Recruitment hospital [2] 0 0
Skin & Cancer Foundation Australia - Westmead
Recruitment hospital [3] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [4] 0 0
Clinical Trials SA Pty Ltd - Campbelltown
Recruitment hospital [5] 0 0
Skin Health Institute Inc. - Carlton
Recruitment hospital [6] 0 0
Sinclair Dermatology - Melbourne
Recruitment hospital [7] 0 0
Fremantle Dermatology - Fremantle
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2045 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5073 - Campbelltown
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
3002 - Melbourne
Recruitment postcode(s) [7] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
State/province [3] 0 0
California
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United States of America
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Connecticut
Country [5] 0 0
United States of America
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Florida
Country [6] 0 0
United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Maryland
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Massachusetts
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United States of America
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Michigan
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Minnesota
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Missouri
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Rhode Island
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Texas
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad Autónoma De Buenos Aires
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Argentina
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Tucuman
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Argentina
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Mendoza
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Brazil
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Rio Grande Do Sul
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Brazil
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RJ
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Brazil
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Brazil
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São Paulo
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Brazil
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Rio de Janeiro
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Beijing
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Guangdong
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Hunan
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Jiangsu
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Shaanxi
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Shanghai
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China
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Shanxi
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China
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Tianjin
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China
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Zhejiang
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Israel
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HaDarom
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Israel
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HaMerkaz
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Israel
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HaTsafon
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Israel
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Tell Abib
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Israel
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Yerushalayim
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Japan
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Kanagawa
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Yamaguchi
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Japan
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Osaka
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Korea, Republic of
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Chungcheongnam-do
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul-teukbyeolsi [Seoul]
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Korea, Republic of
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Seoul
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Puerto Rico
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San Juan
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
State/province [58] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Incyte Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03899259