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

• Status: Active, not recruiting
• Trial end date: 2024-06-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Incyte Corporation

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:

• 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.

• Male or nonpregnant, nonbreastfeeding 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).