Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease
This study is testing a new treatment called Telitacicept for people with active primary Sjögren's Disease. Telitacicept is given as an injection under the skin and works by targeting certain immune pathways that are overactive in autoimmune diseases. Some participants will receive Telitacicept, while others will receive a placebo (an inactive substance). The main goal is to see if Telitacicept improves disease activity after 48 weeks, as measured by a specific score called the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI). You may be able to join if you are between 18 and 75 years old, have primary Sjögren's Syndrome, and have an ESSDAI score of 5 or higher. The study plans to enroll 250 participants.
- Study design
- This is a Phase 3 interventional study that plans to enroll 250 participants. It compares Telitacicept to a placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at Week 48, indicating follow-up for at least this duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease
At a glance
Conditions
Where it's being run
43 sites across 15 statesWho to contact
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What this trial measures
- To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.Week 48
Change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.