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Janus Kinase (JAK) Inhibitor
Baricitinib for Alopecia Areata (BRAVE-AA2 Trial)
Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 36
Awards & highlights
BRAVE-AA2 Trial Summary
This trial is testing if baricitinib is a safe and effective treatment for people with severe or very severe AA.
Who is the study for?
Adults with severe or very severe alopecia areata (AA) for less than 8 years, or those with regrowth in the past 8 years, can join. They must be aged between 18-60 for males and up to 70 for females, not pregnant or breastfeeding, and have had no hair improvement in the last six months.Check my eligibility
What is being tested?
The study is testing if Baricitinib is effective and safe compared to a placebo in adults with severe AA. Participants will either receive Baricitinib or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Baricitinib may cause side effects such as infections, blood clots, cholesterol changes, liver enzyme elevations, and possibly others. The exact side effects experienced by participants will be monitored throughout the trial.
BRAVE-AA2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had severe scalp hair loss for over 6 months.
Select...
My condition has not gotten better on its own in the last 6 months.
Select...
I am a male aged 18-60 or a female aged 18-70.
Select...
I am a man or a woman not pregnant or breastfeeding.
BRAVE-AA2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20
Secondary outcome measures
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 Symptoms Domain Score
+10 moreSide effects data
From 2015 Phase 3 trial • 1307 Patients • NCT0171035810%
Nasopharyngitis
4%
Upper respiratory tract infection
4%
Urinary tract infection
4%
Headache
4%
Pharyngitis
3%
Alanine aminotransferase increased
3%
Back pain
3%
Erectile dysfunction
3%
Nausea
3%
Hypertension
2%
Diarrhoea
2%
Cough
2%
Dyspepsia
2%
Bronchitis
2%
Influenza
2%
Rash
1%
Hypercholesterolaemia
1%
Hyperlipidaemia
1%
Rheumatoid arthritis
1%
Anaemia
1%
Blood creatine phosphokinase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adalimumab Treatment A
Adalimumab Treatment B
Placebo Treatment B
Baricitinib Follow-up
Baricitinib Treatment A
Placebo Follow-up
BaricitinibTreatment B
Adalimumab Follow-up
Placebo Treatment A
Rescue
BRAVE-AA2 Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: 4 mg Baricitinib Maximum Extended Enrollment (MEE)Experimental Treatment2 Interventions
Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.
Group II: 4 Milligram (mg) BaricitinibExperimental Treatment2 Interventions
Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.
Group III: 2 mg Baricitinib MEEExperimental Treatment1 Intervention
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.
Group IV: 2 mg BaricitinibExperimental Treatment2 Interventions
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.
Group V: Placebo MEEPlacebo Group1 Intervention
Participants received two placebo tablets administered orally QD to maintain the blind.
Group VI: PlaceboPlacebo Group1 Intervention
Participants received two placebo tablets administered orally QD to maintain the blind.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Baricitinib
2017
Completed Phase 3
~9510
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,615 Previous Clinical Trials
3,200,512 Total Patients Enrolled
3 Trials studying Alopecia Areata
1,434 Patients Enrolled for Alopecia Areata
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
54,619 Total Patients Enrolled
2 Trials studying Alopecia Areata
914 Patients Enrolled for Alopecia Areata
Study DirectorEli Lilly and Company
8 Previous Clinical Trials
2,658 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: 4 Milligram (mg) Baricitinib
- Group 2: 2 mg Baricitinib
- Group 3: 4 mg Baricitinib Maximum Extended Enrollment (MEE)
- Group 4: 2 mg Baricitinib MEE
- Group 5: Placebo MEE
- Group 6: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers still recruiting patients for this trial?
"The clinical trial is no longer recruiting patients, as reflected on the corresponding clinicaltrials.gov listing which was last updated on 1/24/2022. Although this particular trial has completed recruitment, there are 127 other trials currently looking for participants."
Answered by AI
When will Baricitinib be available for public purchase?
"There is both prior clinical data supporting efficacy and multiple rounds of safety testing, so Baricitinib received a score of 3."
Answered by AI
Could you tell me how many medical facilities are running this trial?
"There are 35 sites currently enrolling patients for this clinical trial. To reduce the inconvenience of travel, participants should try to select a location nearest to them from Northridge, San Francisco, South Bend or the other 32 locations."
Answered by AI
Could elderly individuals be adversely affected by participating in this research?
"The age range for this particular clinical trial is 18 to 70 years old. However, there are 19 other trials available for patients that are below the age of majority and 94 different trials open to senior citizens."
Answered by AI
Are there any medical prerequisites for joining this research project?
"To qualify for this research, patients must have alopecia areata and be between 18-70 years old. This study needs approximately 546 individuals to enroll."
Answered by AI
What have beenbaricitinib’s most successful treatments?
"Baricitinib is most often given to patients that require hospitalization. However, it has also been used to treat conditions such as coronavirus disease 2019 (covid‑19), ecmo treatment, and rheumatoid arthritis."
Answered by AI
Are there any other examples of Baricitinib's efficacy?
"Baricitinib was first studied in 2007 by University of Nebraska Medical Center. Since then, there have been 18299 completed trials worldwide. As of right now, 34 clinical trials are actively recruiting patients with a large number taking place out of Northridge, California."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
Florida
California
Other
How old are they?
65+
18 - 65
What site did they apply to?
University of North Carolina Dermatology and Skin Cancer Cen
University Hospitals Cleveland Medical Center
Center For Dermatology Clinical Research, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I've tried Finasteride and Minoxidil oral medication but did not work. I’ve tried the shots at your office, creams etc hoping to find something that works I am under salt score of 30.
PatientReceived 1 prior treatment
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