Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease
Recruiting · NCT07404865 · Interventional (participants receive a specific treatment) · Lead sponsor: Vor Biopharma
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboTelitacicept
What this trial is about
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
43 locations listed across 15 US states.
- Arizona Arthritis & Rheumatology Associates P.C. - Chandler, Arizona, United States
- Arizona Arthritis & Rheumatology Associates P.C. - Flagstaff, Arizona, United States
- Arizona Arthritis & Rheumatology Associates, PLLC - Glendale, Arizona, United States
- Arizona Arthritis & Rheumatology Associates P.C. - Phoenix, Arizona, United States
- Arizona Arthritis & Rheumatology Associates, P.C. - Tucson, Arizona, United States
- Wallace Rheumatic Study Center - Beverly Hills, California, United States
- Denver Arthritis Clinic - Denver, Colorado, United States
- Tekton Research - Fort Collins, Colorado, United States
- Clinical Research of West Florida, Inc. - Tampa, Colorado, United States
- Clinical Research of West Florida - Corporate - Clearwater, Florida, United States
- Clinical Research of West Florida, Inc. - Clearwater, Florida, United States
- GNP Research - Cooper City, Florida, United States
- Finlay Medical Research Corp - Green Acres, Florida, United States
- Suncoast Clinical Research Inc. - New Port Richey, Florida, United States
- Sarasota Arthritis Center - Sarasota, Florida, United States
- Bioresearch Partners - South Miami, Florida, United States
- Bioresearch Partner - South Miami, Florida, United States
- Conquest Research - Winter Park, Florida, United States
- St. Luke's Clinic - Rheumatology - Boise, Idaho, United States
- Chicago Clinical Research Institute Inc - Chicago, Illinois, United States
- Clinical Investigation Specialist - Schaumburg, Illinois, United States
- Willow Rheumatology & Wellness - Willowbrook, Illinois, United States
- Accurate Clinical Research, Inc. - Lake Charles, Louisiana, United States
- Arthritis and Rheumatism Associates - Rockville, Maryland, United States
- Tufts Medical Center - Boston, Massachusetts, United States
- Clinical Research Institute of Michigan, LLC - Saint Clair Shores, Michigan, United States
- Kansas City Physician Partners - Kansas City, Missouri, United States
- Arthritis and Osteoporosis Consultants of the Carolinas - Charlotte, North Carolina, United States
- Altoona Center for Clinical Research, P.C. - Duncansville, Pennsylvania, United States
- Rheumatic Disease Associates, Ltd. - Willow Grove, Pennsylvania, United States
- Allen Arthritis - Allen, Texas, United States
- Arthritis and Rheumatology Research Institute, PLLC - Allen, Texas, United States
- Amarillo Premier Research, LLC - Amarillo, Texas, United States
- Accurate Clinical Research - Baytown, Texas, United States
- Novel Research LLC - Bellaire, Texas, United States
- Helios CR Inc - Dallas, TX - Dallas, Texas, United States
- Precision Comprehensive Clinical Research Solutions - Euless, Texas, United States
- Lone Star Arthritis & Rheumatology - Fort Worth, Texas, United States
- Accurate Clinical Research, Inc. - Houston, Texas, United States
- Precision Comprehensive Clinical Research Solution - Irving, Texas, United States
- R&H Clinical Research Inc. - Katy, Texas, United States
- Velocity Clinical Research, Waco - Waco, Texas, United States
- Tidewater Clinical Research - Chesapeake, Virginia, United States