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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 52
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 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
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 at Week 36
Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36
Change From Baseline in Skindex-16 Alopecia Areata (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
BaricitinibTreatment B
Placebo Follow-up
Baricitinib Follow-up
Baricitinib Treatment A
Placebo Treatment B
Adalimumab Treatment 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Alopecia Areata include JAK inhibitors like Baricitinib, which work by interfering with the JAK-STAT signaling pathways that are involved in the immune response. By inhibiting these pathways, JAK inhibitors can reduce inflammation and autoimmunity, which are key factors in Alopecia Areata.
Other treatments include corticosteroids, which suppress the immune system to reduce inflammation, and immunosuppressants like methotrexate and cyclosporine, which also modulate the immune response. Understanding these mechanisms is crucial for patients as it highlights the importance of targeting the immune system to manage and potentially reverse hair loss in Alopecia Areata.
Case Report: Successful Treatment of Alopecia Universalis With Tofacitinib and Increased Cytokine Levels: Normal Therapeutic Reaction or Danger Signal?
Case Report: Successful Treatment of Alopecia Universalis With Tofacitinib and Increased Cytokine Levels: Normal Therapeutic Reaction or Danger Signal?
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,624 Previous Clinical Trials
3,216,378 Total Patients Enrolled
3 Trials studying Alopecia Areata
1,434 Patients Enrolled for Alopecia Areata
Incyte CorporationIndustry Sponsor
368 Previous Clinical Trials
54,915 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.
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