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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03899259
Ethics application status
Date submitted
1/04/2019
Date registered
2/04/2019
Date last updated
5/08/2019

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: Baricitinib High Dose - Baricitinib administered orally. Placebo administered orally to maintain the blind.

Experimental: Baricitinib Low Dose - Baricitinib administered orally. Placebo administered orally to maintain the blind.

Placebo Comparator: Placebo - Placebo administered orally.


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 Alopecia Areata Investigator Global Assessment (AA-IGA™) 0 or 1 with a =2 Point Improvement - Percentage of participants achieving AA-IGA™ 0 or 1 with a =2 point improvement
Timepoint [1] 0 0
Week 36
Secondary outcome [1] 0 0
Percent Change from Baseline in Severity of Alopecia Tool (SALT) Score - Percent change from baseline in SALT score
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Percentage of Participants Achieving 75% Improvement of Severity of Alopecia Tool (SALT75) - Percentage of participants achieving SALT75
Timepoint [2] 0 0
Week 36
Secondary outcome [3] 0 0
Percentage of Participants with Patient-Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 - Percentage of participants with PRO for scalp hair assessment score of 0 or 1
Timepoint [3] 0 0
Week 36
Secondary outcome [4] 0 0
Time to Achieve AA-IGA™ 0 or 1 with a =2 Point Improvement - Time to achieve AA-IGA™ 0 or 1 with a =2 point improvement
Timepoint [4] 0 0
Baseline through Week 36
Secondary outcome [5] 0 0
Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 (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 (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 (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 (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 PRO Measure for EB 0 or 1 (Among Participants with PRO Measure for EB =2 at Baseline) - Percentage of participants achieving PRO measure for EB 0 or 1 (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 (Among Participants with PRO Measure EL =2 at Baseline) - Percentage of participants achieving PRO measure for EL 0 or 1 (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 AA Symptoms Domain Score - Change from Baseline in Skindex-16 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 - Change from Baseline in Skindex-16 AA Emotions Domain Score
Timepoint [10] 0 0
Baseline, Week 36
Secondary outcome [11] 0 0
Change from Baseline in Skindex-16 AA Functioning Domain Score - Change from Baseline in Skindex-16 AA Functioning Domain Score
Timepoint [11] 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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 - Adelaide
Recruitment hospital [5] 0 0
Skin and Cancer Foundation Inc. - Carlton
Recruitment hospital [6] 0 0
Fremantle Dermatology - Perth
Recruitment hospital [7] 0 0
Sinclair Dermatology - Victoria
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5073 - Adelaide
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
6160 - Perth
Recruitment postcode(s) [7] 0 0
3002 - Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
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New Hampshire
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
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North Carolina
Country [16] 0 0
United States of America
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Ohio
Country [17] 0 0
United States of America
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Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Rhode Island
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Tucuman
Country [23] 0 0
Argentina
State/province [23] 0 0
Ciudad Autonoma Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Mendoza
Country [25] 0 0
Brazil
State/province [25] 0 0
Rio Grande Do Sul
Country [26] 0 0
Brazil
State/province [26] 0 0
RJ
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Brazil
State/province [27] 0 0
Sao Paulo
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Brazil
State/province [28] 0 0
São Paulo
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Israel
State/province [29] 0 0
Afula
Country [30] 0 0
Israel
State/province [30] 0 0
Beer Sheva
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Israel
State/province [31] 0 0
Haifa
Country [32] 0 0
Israel
State/province [32] 0 0
Jerusalem
Country [33] 0 0
Israel
State/province [33] 0 0
Petach Tikva
Country [34] 0 0
Israel
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Ramat Gan
Country [35] 0 0
Israel
State/province [35] 0 0
Tel Aviv
Country [36] 0 0
Japan
State/province [36] 0 0
Kanagawa
Country [37] 0 0
Japan
State/province [37] 0 0
Shizuoka
Country [38] 0 0
Japan
State/province [38] 0 0
Tokyo
Country [39] 0 0
Japan
State/province [39] 0 0
Yamaguchi
Country [40] 0 0
Japan
State/province [40] 0 0
Osaka
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Chungcheongnam-do
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Gyeonggi-do
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Seoul
Country [44] 0 0
Puerto Rico
State/province [44] 0 0
San Juan
Country [45] 0 0
Taiwan
State/province [45] 0 0
Taichung City (r.o.c)
Country [46] 0 0
Taiwan
State/province [46] 0 0
Tainan
Country [47] 0 0
Taiwan
State/province [47] 0 0
Taipei City
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taipei

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
The reason for this study is to see if baricitinib is safe and effective in adults with
severe or very severe alopecia areata (AA).
Trial website
https://clinicaltrials.gov/show/NCT03899259
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
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
clinicaltrials.gov@lilly.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03899259