250 Participants Needed

Potential Treatment for Sjögren's Disease

(UPSTREAM SjD Trial)

Recruiting at 16 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Vor Biopharma
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

Current available treatment options for Sjögren's disease only help to manage the symptoms, and doctors still do not know how well they work for everyone. There is a need for newer treatment options for people living with Sjögren's disease that may help manage the condition better. The UPSTREAM SjD Study is looking at an investigational medication called telitacicept for people with Sjögren's disease to find out whether it works and how safe it is.

Why do researchers think this study treatment might be promising?

The study drug is designed to potentially block 2 proteins in the body (BLyS and APRIL) that help certain immune cells survive and produce antibodies. When too many antibodies are produced, they can sometimes begin attacking healthy cells. By blocking BLyS and APRIL, the study drug may help calm the overactive immune system and reduce the activity of Sjögren's disease.

Timeline

Screening

Participants are evaluated to confirm eligibility

Approximately 4 weeks
1 Visit

Treatment Period

Weekly injections - either on-site or at home. Total of 49 in-clinic and virtual visits, with at least 13 in-clinic visits.

Up to 11 months
49 Visits

Follow-up

Participants are monitored after completing treatment.

Up to 2 months
2 Visits