Clinical Trials
UPSTREAM SjD
Telitacicept in Active Primary Sjögren’s Disease
The UPSTREAM SjD Phase 3 global study is evaluating the efficacy and safety of telitacicept in patients with Active Primary Sjögren’s Disease.
The ongoing Phase 3 global trial is a randomized, double-blind, placebo-controlled study.
Objective
To assess the impact of telitacicept on EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) scores in patients with Active Primary Sjögren’s Disease.
Endpoints
Primary
Change from baseline in the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score at Week 48
Secondary
- Change from baseline in the stimulated whole salivary flow at Week 48
- Change from baseline in the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score at Week 48
- Change from baseline in the physician’s global assessment of disease activity (Physician GDA) score at Week 48
- Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at Week 48
- Change from baseline in the participant’s global assessment of disease activity (Patient GDA) at Week 48
Enrollment
~250 patients across North America, Europe, Latin America and Asia-Pacific.
If you have questions about our Phase 3 study in SjD, please email sjdstudy@vorbio.com.