Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT05673993
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2022-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome
Sponsor:
RemeGen Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase Ⅲ, Multi-center, Randomized, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Subcutaneous Telitacicept in Subjects With Active Primary Sjogren's Syndrome
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 subcutaneous Telitacicept versus placebo in subjects with active primary Sjogren's Syndrome.
Detailed Description:
This is a phase Ⅲ, multi-center, randomized, double-blind, placebo-controlled study. Subjects with active primary Sjogren's Syndrome (pSS) will be randomized to receive subcutaneous Telitacicept 80 mg, Telitacicept 160 mg or placebo weekly for a total of 48 weeks. Subjects are allowed to be transferred to another group after Week 24 by the investigator so that those randomized to the placebo group are able to receive either Telitacicept 80 mg or Telitacicept 160 mg afterwards. Subjects who are randomized to Telitacicept 80 mg and Telitacicept 160 mg groups will remain in the previous treatment group even if the investigator chooses to transfer them. Subjects and investigators are blinded throughout the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: