Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562894
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-18
Brief Title:
Study to Evaluate Safety and Efficacy of SYHX1901 Tablets in Severe Alopecia Areata Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SYHX1901 Tablets in the Treatment of Severe Alopecia Areata
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 weeks which will be comprised of a screening period 4 weeks a core treatment period 24 weeksa extended treatment period28 weeksand a follow-up assessment period 4 weeks Eligible subjects will be randomly assigned to SYHX1901 dose 1 dose 2dose 3 or placebo group at a 1221 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 2dose 3 group will remain the same dose for 28 weeks The SALTSeverity of ALopecia Tool score will be a stratification factor Subjects will be monitored for the safety throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None