The purpose of this study is to evaluate the efficacy and safety of different doses of SYHX1901 tablets in the treatment of severe alopecia areata.
This is a multicenter, randomized, double-blind, placebo-controlled phase II study to evaluate the efficacy and safety of two different doses of SYHX1901 tablets compared with placebo in the treatment of severe alopecia areata. The total duration of the study will be 56 60 weeks which will be comprised of: a screening period (4 weeks); a core treatment period (24 weeks),a extended treatment period(28 weeks)and a follow-up assessment period (4 weeks). Eligible subjects will be randomly assigned to SYHX1901 dose 1 , dose 2,dose 3 or placebo group at a 1:2:2:1 ratio for continuous oral administration for 24 weeks, then placebo group will receive SYHX1901 at dose 3 for 28 weeks, the SYHX1901 dose 1, dose 2,dose 3 group will remain the same dose for 28 weeks. The SALT(Severity of AlLopecia Tool) score will be a stratification factor. Subjects will be monitored for the safety throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
Percentage of subjects with Alopecia Severity Score Tool (SALT) score < or = 20%
Percentage of subjects achieving a SALT score \< or = 20% at week 24
Time frame: Week 24
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