Completed Enrollment

A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata (BRAVE-AA1)

I4V-MC-JAHO -

This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata.

Trial Summary

Age Range
18 - 70 years
Conditions the trial is for
Alopecia Areata (hair loss)
What the trial is testing?
Baricitinib
Could I receive a Placebo?
Yes
Enrollment Goal
824
Trial Dates
Sep 24, 2018 - Jan 2025
How long will I be in the trial?
The study will last about 104 weeks and may include up to 18 visits.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • At least be 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent

  • Have severe or very severe alopecia areata (AA), as determined by all of the following:

    • Current AA episode of more than 6 months' duration and hair loss encompassing at least half of the scalp

    • No spontaneous improvement in previous 6 months

    • Current episode of severe to very severe alopecia areata of less than 8 years

  • Be male or nonpregnant, nonbreastfeeding female participants

  • Self-identify as either Black or African American in race in the open label addenda

Participants Must Not:

  • Have primarily "diffuse" type of alopecia areata

  • Be currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on alopecia areata

  • Be 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)

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