Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease
UPSTREAM SjD
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
4 other identifiers
interventional
250
1 country
26
Brief Summary
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2026
Typical duration for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2026
CompletedFirst Posted
Study publicly available on registry
February 12, 2026
CompletedStudy Start
First participant enrolled
February 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
June 4, 2026
March 1, 2026
2.8 years
February 4, 2026
June 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.
Change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.
Week 48
Secondary Outcomes (6)
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the treatment of adult participants with pSD.
Week 48
To evaluate the efficacy of telitacicept versus placebo in improving glandular function during the trial.
Week 48
To evaluate the effect of telitacicept versus placebo in improving patient-reported outcomes (i.e., how participants feel and function) during the trial.
Week 48
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the physician's global assessment of disease activity (Physician GDA) score at Week 48
Week 48
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at Week 48
Week 48
- +1 more secondary outcomes
Study Arms (2)
Telitacicept
EXPERIMENTALTelitacicept
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vor Biopharmalead
Study Sites (26)
Arizona Arthritis & Rheumatology Associates P.C.
Chandler, Arizona, 85225, United States
Arizona Arthritis & Rheumatology Associates P.C.
Flagstaff, Arizona, 86001, United States
Arizona Arthritis & Rheumatology Associates, PLLC
Glendale, Arizona, 85306, United States
Arizona Arthritis & Rheumatology Associates P.C.
Phoenix, Arizona, 85392, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Tucson, Arizona, 85704, United States
Wallace Rheumatic Study Center
Beverly Hills, California, 90210, United States
Denver Arthritis Clinic
Denver, Colorado, 80230, United States
Finlay Medical Research Corp
Green Acres, Florida, 33467, United States
Suncoast Clinical Research Inc.
New Port Richey, Florida, 34652, United States
Chicago Clinical Research Institute Inc
Chicago, Illinois, 60607, United States
Clinical Investigation Specialist
Schaumburg, Illinois, 60195, United States
Willow Rheumatology & Wellness
Willowbrook, Illinois, 60527, United States
Accurate Clinical Research, Inc.
Lake Charles, Louisiana, 70605, United States
Arthritis and Rheumatism Associates
Rockville, Maryland, 20850, United States
Altoona Center for Clinical Research, P.C.
Duncansville, Pennsylvania, 16635, United States
Rheumatic Disease Associates, Ltd.
Willow Grove, Pennsylvania, 19090, United States
Allen Arthritis
Allen, Texas, 75013, United States
Arthritis and Rheumatology Research Institute, PLLC
Allen, Texas, 75013, United States
Accurate Clinical Research
Baytown, Texas, 77521, United States
Novel Research LLC
Bellaire, Texas, 77401, United States
Precision Comprehensive Clinical Research Solutions
Euless, Texas, 76040, United States
Lone Star Arthritis & Rheumatology
Fort Worth, Texas, 76109, United States
Accurate Clinical Research, Inc.
Houston, Texas, 77089, United States
R&H Clinical Research Inc.
Katy, Texas, 77450, United States
Velocity Clinical Research, Waco
Waco, Texas, 76710, United States
Tidewater Clinical Research
Chesapeake, Virginia, 23320, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2026
First Posted
February 12, 2026
Study Start
February 26, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
January 1, 2029
Last Updated
June 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share