What the trial was testing
The BRAVE-AA1 enrolled 784 patients with alopecia areata. The study was sponsored by Eli Lilly and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was mid-stage testing (phase 2/3). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
39% had near-complete scalp regrowth at 36 weeks vs. 6% on the comparison pill.
New England Journal of Medicine · 2022 · NCT03570749
These findings — that achieved near-complete scalp regrowth at 36 weeks on 4 mg baricitinib — were published in the New England Journal of Medicine and represent the headline result of the study.
Researchers tracked outcomes across 784 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with alopecia areata, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Baricitinib (Olumiant) is FDA-approved for severe alopecia areata in adults and available now. It is taken once daily as a pill. Side effects to watch for include infections, blood clots, and changes in cholesterol. Ask a dermatologist about whether you qualify and what monitoring is needed.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open alopecia areata trials
Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata
This study evaluates the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have 50% or greater scalp hair loss.
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
This is a first-in-human study of ABS-201, a new investigational medicine, in healthy adult men and women. Its main purpose is to find out whether ABS-201 is safe and well tolerated, as well as to understand how the body processes it and how it affects related biological markers. ABS-201 is being developed as a possible treatment for androgenetic alopecia (male- and female-pattern hair loss); its effect on hair growth has not yet been established. The study has two parts: in the single ascending dose (SAD) part, healthy adults receive one intravenous dose of ABS-201 or placebo; and in the multiple ascending dose (MAD) part, participants (including men with androgenetic alopecia) receive several subcutaneous doses of ABS-201 or placebo. The MAD part also evaluates the effect of ABS-201 on hair growth. The main questions it aims to answer are: What medical problems, if any, do participants experience when taking a single dose or many doses of ABS-201? How does the medication, ABS-201, compare to placebo (a look alike substance that does not contain any medication). Participants who qualify for the trial will receive either ABS-201 or a placebo, and visit the study clinic for scheduled checkups and tests for approximately 12 months in the single ascending dose (SAD) part and approximately 18 months in the multiple ascending dose (MAD) part. In the MAD part, participants receive repeated subcutaneous doses.