Sjögren’s Disease (SjD)

Smiling Mature Woman Standing In A Park Outdoors In The Summertime

Understanding Sjögren’s Disease

Sjögren’s disease is a chronic autoimmune condition in which the immune system attacks moisture-producing glands and, in many cases, other organs. Hallmark symptoms include dry eyes and dry mouth, alongside fatigue, pain, and systemic complications affecting the skin, lungs, kidneys, and nervous system. About one-third of patients develop significant extraglandular involvement, and the disease carries an elevated lymphoma risk, often leading to substantial impairment in daily life.

One of the most common rheumatic autoimmune diseases, Sjögren’s remains underdiagnosed, with roughly half of cases unrecognized and women comprising the vast majority of patients.

Despite its prevalence and burden, there are currently limited treatment options available, and many patients rely on symptom management.

Telitacicept is an investigational drug. It has not been approved by the U.S. Food and Drug Administration (FDA). The safety and efficacy of telitacicept have not been established.

 

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.