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Clinical Trials in the USA / NCT07404865
Recruiting Phase 3

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

NCT07404865 · tracked via the Priya Life Science USA tracker
Sponsor
Vor Biopharma
Phase
Phase 3
Started
2026-02-26
Last updated
2026-08-27

Condition(s) studied

Primary Sjogren's Disease

Investigational drug(s) / intervention(s)

TelitaciceptPlacebo

Telitacicept: Subcutaneous injection

Placebo: Subcutaneous injection

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (43)

FacilityCityRegionStatus
Arizona Arthritis & Rheumatology Associates P.C. Chandler Arizona Recruiting
Arizona Arthritis & Rheumatology Associates P.C. Flagstaff Arizona Recruiting
Arizona Arthritis & Rheumatology Associates, PLLC Glendale Arizona Recruiting
Arizona Arthritis & Rheumatology Associates P.C. Phoenix Arizona Recruiting
Arizona Arthritis & Rheumatology Associates, P.C. Tucson Arizona Recruiting
Wallace Rheumatic Study Center Beverly Hills California Recruiting
Denver Arthritis Clinic Denver Colorado Recruiting
Tekton Research Fort Collins Colorado Recruiting
Clinical Research of West Florida, Inc. Tampa Colorado Recruiting
Clinical Research of West Florida - Corporate Clearwater Florida Recruiting
Clinical Research of West Florida, Inc. Clearwater Florida Recruiting
GNP Research Cooper City Florida Recruiting
Finlay Medical Research Corp Green Acres Florida Recruiting
Suncoast Clinical Research Inc. New Port Richey Florida Recruiting
Sarasota Arthritis Center Sarasota Florida Recruiting
Bioresearch Partners South Miami Florida Recruiting
Bioresearch Partner South Miami Florida Recruiting
Conquest Research Winter Park Florida Recruiting
St. Luke's Clinic - Rheumatology Boise Idaho Recruiting
Chicago Clinical Research Institute Inc Chicago Illinois Recruiting
Clinical Investigation Specialist Schaumburg Illinois Recruiting
Willow Rheumatology & Wellness Willowbrook Illinois Recruiting
Accurate Clinical Research, Inc. Lake Charles Louisiana Recruiting
Arthritis and Rheumatism Associates Rockville Maryland Recruiting
Tufts Medical Center Boston Massachusetts Recruiting
Clinical Research Institute of Michigan, LLC Saint Clair Shores Michigan Recruiting
Kansas City Physician Partners Kansas City Missouri Recruiting
Arthritis and Osteoporosis Consultants of the Carolinas Charlotte North Carolina Recruiting
Altoona Center for Clinical Research, P.C. Duncansville Pennsylvania Recruiting
Rheumatic Disease Associates, Ltd. Willow Grove Pennsylvania Recruiting
Allen Arthritis Allen Texas Recruiting
Arthritis and Rheumatology Research Institute, PLLC Allen Texas Recruiting
Amarillo Premier Research, LLC Amarillo Texas Recruiting
Accurate Clinical Research Baytown Texas Recruiting
Novel Research LLC Bellaire Texas Recruiting
Helios CR Inc - Dallas, TX Dallas Texas Recruiting
Precision Comprehensive Clinical Research Solutions Euless Texas Recruiting
Lone Star Arthritis & Rheumatology Fort Worth Texas Recruiting
Accurate Clinical Research, Inc. Houston Texas Recruiting
Precision Comprehensive Clinical Research Solution Irving Texas Recruiting

+ 3 more sites — see the full list on the official registry below.

More Vor Biopharma trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07404865 on ClinicalTrials.gov ↗ ← All trials in the USA