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Phase II-III

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

  • Study HIC#:2000023903
  • Last Updated:02/06/2019

Brief Summary:

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.

  • Age18 years - 70 years
  • GenderBoth
  • Start Date01/02/2019
  • End Date12/30/2018

Trial Purpose and Description

To test the hypothesis that the high dose of baricitinib selected at the Decision Point is superior to placebo in the treatment of patients with severe AA.

Eligibility Criteria

Inclusion Criteria: 

Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent.

Have severe or very severe AA, as determined by all of the following:
9702;hair loss encompassing ≥50% of the scalp, as measured by SALT (AA-IGA of 3 or 4) at screening and baseline.
9702;no spontaneous improvement over the past 6 months.
9702;current episode of severe or very severe AA of less than 8 years. Note: participants who have severe or very severe AA for 8805;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.

Male or non-pregnant, non-breastfeeding female participants.

Exclusion Criteria:
Primarily "diffuse" type of AA.
Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA.
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).

Principal Investigator

Sub-Investigator

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