Completed Enrollment

A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata (BRAVE-AA2)

The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).

Trial Summary

Age Range
18 - 70 years
Conditions the trial is for
Alopecia Areata (Hair Loss)
What the trial is testing?
Baricitinib, Placebo
Could I receive a Placebo?
Yes
Enrollment Goal
546
Trial Dates
Jul 8, 2019 - Jul 2024
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:

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

  • Participants must have severe or very severe AA, as determined by all of the following: - 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 - current episode of severe or very severe AA of less than 8 years. Note: participants who have severe or very severe AA for 8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years

  • Participant must be male or nonpregnant, nonbreastfeeding female participants

Participants Must Not:

  • Participants must not have primarily diffuse type of AA

  • Participants must not be currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA

  • Participants must not have been 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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