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.

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NCT07404865

Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease

Recruiting
PHASE3Ages 18–75InterventionalTreatment
Vor Biopharma
~250 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:TelitaciceptPlacebo

At a glance

Recruiting sites
43 of 43 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over Week 48
Primary Sjogren's Disease
43 sites across 15 states
Texas12
Florida9
Arizona5
Colorado3
Illinois3
Pennsylvania2
California1
Idaho1

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  • 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.