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

• Status: Active, not recruiting
• Trial end date: 2024-05-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: 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).