Baricitinib for Alopecia Areata (BRAVE-AA2 Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Eli Lilly and Company
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing baricitinib to see if it is safe and effective for adults with severe hair loss due to alopecia areata. The drug works by calming the immune system to prevent it from attacking hair follicles. Baricitinib was approved by the FDA for treating severe alopecia areata.
Eligibility Criteria
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.Inclusion Criteria
I have had severe scalp hair loss for over 6 months.
My condition has not gotten better on its own in the last 6 months.
I am a male aged 18-60 or a female aged 18-70.
I am a man or a woman not pregnant or breastfeeding.
Exclusion Criteria
My condition is primarily the 'diffuse' type of astrocytoma.
I took a JAK inhibitor for over 12 weeks without seeing hair growth.
Treatment Details
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.
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.
Baricitinib is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Olumiant for:
- Rheumatoid arthritis
- Severe alopecia areata
- COVID-19
🇪🇺 Approved in European Union as Olumiant for:
- Rheumatoid arthritis
- Severe alopecia areata
- COVID-19
Find a clinic near you
Research locations nearbySelect from list below to view details:
Vital Prospects Clinical Research Institute, P.C.Tulsa, OK
The University of North Carolina at Chapel HillChapel Hill, NC
Dermatologists of Southwest OhioMason, OH
Velocity Clinical Research, ProvidenceEast Greenwich, RI
More Trial Locations
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
Incyte CorporationIndustry Sponsor