Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT06562894
Brief Summary:
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.
Detailed Description:
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:
NCT06562894
Study Brief:
Protocol Section:
NCT06562894