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
- Allen, Amarillo, Baytown, Bellaire, Beverly Hills, Boise, Boston, Chandler, Charlotte, Chesapeake, Chicago, Clearwater, Cooper City, Dallas, Denver, Duncansville, Durham, Euless, Flagstaff, Fort Collins, Fort Worth, Glendale, Green Acres, Houston, Irving, Kansas City, Katy, Lake Charles, Miami, New Port Richey, Oklahoma City, Philadelphia, Phoenix, Rockville, Saint Clair Shores, Sarasota, Schaumburg, South Miami, Tampa, Tucson, Waco, Willow Grove, Willowbrook, and Winter Park, United StatesSee the 47 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 United States
- Allen ArthritisAllen, United StatesTaking people
- Arthritis and Rheumatology Research Institute, PLLCAllen, United StatesTaking people
- Amarillo Premier Research, LLCAmarillo, United StatesTaking people
- Accurate Clinical ResearchBaytown, United StatesTaking people
- Novel Research LLCBellaire, United StatesTaking people
- Wallace Rheumatic Study CenterBeverly Hills, United StatesTaking people
- St. Luke's Clinic - RheumatologyBoise, United StatesTaking people
- Tufts Medical CenterBoston, United StatesTaking people
- Arizona Arthritis & Rheumatology Associates P.C.Chandler, United StatesTaking people
- Arthritis and Osteoporosis Consultants of the CarolinasCharlotte, United StatesTaking people
- Tidewater Clinical ResearchChesapeake, United StatesTaking people
- Chicago Clinical Research Institute INCChicago, United StatesTaking people
- Clinical Research of West Florida - CorporateClearwater, United StatesTaking people
- Clinical Research of West Florida, Inc.Clearwater, United StatesTaking people
- GNP ResearchCooper City, United StatesTaking people
- Helios CR Inc - Dallas, TXDallas, United StatesTaking people
- Denver Arthritis ClinicDenver, United StatesTaking people
- Altoona Center for Clinical Research, P.C.Duncansville, United StatesTaking people
- Duke University Medical CenterDurham, United StatesTaking people
- Precision Comprehensive Clinical Research SolutionsEuless, United StatesTaking people
- Arizona Arthritis & Rheumatology Associates P.C.Flagstaff, United StatesTaking people
- Tekton ResearchFort Collins, United StatesTaking people
- Lone Star Arthritis & RheumatologyFort Worth, United StatesTaking people
- Arizona Arthritis & Rheumatology Associates, PLLCGlendale, United StatesTaking people
- Finlay Medical Research CorpGreen Acres, United StatesTaking people
- Accurate Clinical Research, IncHouston, United StatesTaking people
- Precision Comprehensive Clinical Research SolutionIrving, United StatesTaking people
- Kansas City Physician PartnersKansas City, United StatesTaking people
- R&H Clinical Research, Inc.Katy, United StatesTaking people
- Accurate Clinical Research, IncLake Charles, United StatesTaking people
- Clever Medical ResearchMiami, United StatesTaking people
- Suncoast Clinical Research, Inc.New Port Richey, United StatesTaking people
- Oklahoma Medical Research FoundationOklahoma City, United StatesTaking people
- Clinical Research of Philadelphia, LLCPhiladelphia, United StatesTaking people
- Arizona Arthritis & Rheumatology Associates P.C.Phoenix, United StatesTaking people
- Arthritis and Rheumatism AssociatesRockville, United StatesTaking people
- Clinical Research Institute of Michigan, LLCSaint Clair Shores, United StatesTaking people
- Sarasota Arthritis CenterSarasota, United StatesTaking people
- Clinical Investigation SpecialistSchaumburg, United StatesTaking people
- Bioresearch PartnerSouth Miami, United StatesTaking people
- Bioresearch PartnersSouth Miami, United StatesTaking people
- Clinical Research of West Florida IncTampa, United StatesTaking people
- Arizona Arthritis & Rheumatology Associates, P.C.Tucson, United StatesTaking people
- Velocity Clinical Research, WacoWaco, United StatesTaking people
- Rheumatic Disease Associates, Ltd.Willow Grove, United StatesTaking people
- Willow Rheumatology WellnessWillowbrook, United StatesTaking people
- Conquest ResearchWinter Park, United StatesTaking 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.