Tests telitacicept against placebo in adults with active primary Sjögren's disease
Tests telitacicept, compared with placebo, in adults with active Sjögren's disease.
Plain-language title generated from the registry record
Registry title: Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease
Key facts
- Where
- Plovdiv and Sofia, BulgariaSee the 3 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07404865, who can take part
Where in Bulgaria
- Medical Centre EpionaPlovdiv, BulgariaTaking people
- University Hospital LozenetzSofia, BulgariaTaking people
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EADSofia, BulgariaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vor Biopharma
- Trial code
- NCT07404865EU 2026-525556-28-00
- Record updated
- 19 October 2026
- Original description
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)Read full original descriptionShow less
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept in Adult Participants With Active Primary Sjögren's Disease
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)
Inclusion: Male or female aged 18 to 75 years of age (both inclusive) at screening; Participants must meet the 2016 American College of Rheumatology (ACR)/EULAR classification criteria for primary Sjogren's Syndrome at the time of screening; ESSDAI ≥5 at screening (score calculated excluding renal, pulmonary and neurological domains); Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)/Anti-Sjogren's Syndrome A (Ro) at the Screening Visit; Additional inclusion criteria are defined in the protocol.
Exclusion: Participants who have a systemic autoimmune disease other than Primary Sjogren's Disease, such as rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis, that can better explain the majority of the symptoms (i.e., secondary Sjogren's Disease); Participants who have another autoimmune disease or inflammatory condition that could interfere with assessment of response of Primary Sjogren's Disease to therapy (e.g., systemic sclerosis, inflammatory bowel disease, gout); Participants with severe fibromyalgia that could interfere with the assessment of response of Primary Sjogren's Disease to therapy; Active life-threatening or organ-threatening complications of Primary Sjogren's Disease at the time of screening based on investigator evaluation; Significant, uncontrolled medical disease in any organ system not related to Primary Sjogren's Disease (e.g., poorly controlled asthma, cardiovascular disease, accelerated hypertension, major depression, etc.) that in the opinion of the investigator would preclude participant participation; Additional exclusion criteria are defined in the protocol.