Alopecia Areata (Hair Loss)
A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).
The study will last about 104 weeks and may include up to 18 visits.
Key Participation Requirements
All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria
Inclusion Criteria: -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
Exclusion Criteria: -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)