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

NCT07404865

RecruitingPhase 3

Sponsor: Vor Biopharma

Conditions: Primary Sjogren's Disease

Interventions: Telitacicept, Placebo

Countries: United States

Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. Male or female aged 18 to 75 years of age (both inclusive) at screening
2. Participants must meet the 2016 American College of Rheumatology (ACR)/EULAR classification criteria for primary Sjogren's Syndrome at the time of screening.
3. ESSDAI ≥5 at screening (score calculated excluding renal, pulmonary and neurological domains)
4. 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 Criteria:

1. 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)
2. 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).
3. Participants with severe fibromyalgia that could interfere with the assessment of response of Primary Sjogren's Disease to therapy
4. Active life-threatening or organ-threatening complications of Primary Sjogren's Disease at the time of screening based on investigator evaluation
5. 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
Locations (28)
  • Chandler, Arizona, United States
  • Flagstaff, Arizona, United States
  • Glendale, Arizona, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Beverly Hills, California, United States
  • Denver, Colorado, United States
  • Clearwater, Florida, United States
  • Green Acres, Florida, United States
  • New Port Richey, Florida, United States
  • South Miami, Florida, United States
  • Chicago, Illinois, United States
  • Schaumburg, Illinois, United States
  • Willowbrook, Illinois, United States
  • Lake Charles, Louisiana, United States
  • Rockville, Maryland, United States
  • Duncansville, Pennsylvania, United States
  • Willow Grove, Pennsylvania, United States
  • Allen, Texas, United States
  • Allen, Texas, United States
  • Baytown, Texas, United States
  • Bellaire, Texas, United States
  • Euless, Texas, United States
  • Fort Worth, Texas, United States
  • Houston, Texas, United States
  • Katy, Texas, United States
  • Waco, Texas, United States
  • Chesapeake, Virginia, United States