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

RecruitingPhase 3Ages 18 Years - 75 YearsAllVor Biopharma
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Telitacicept
  • Placebo
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Where

49 sites
Arizona Arthritis & Rheumatology Associates P.C.
Chandler, United States
Arizona Arthritis & Rheumatology Associates P.C.
Flagstaff, United States
Arizona Arthritis & Rheumatology Associates, PLLC
Glendale, United States
Arizona Arthritis & Rheumatology Associates P.C.
Phoenix, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Tucson, United States
Wallace Rheumatic Study Center
Beverly Hills, United States
Denver Arthritis Clinic
Denver, United States
Tekton Research
Fort Collins, United States

…and 41 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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