A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
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. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.
Inclusion Criteria:
Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent.
Must self-identify as either Black or African American in race in the open label addenda.
Have severe or very severe AA, as determined by all of the following:
Exclusion Criteria:
Shinjuku-ku, Tokyo 160-0023, Japan
Jung-gu, Incheon 22332, South Korea