Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease
ConditionPrimary Sjogren's Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVor Biopharma
About this trial
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Telitacicept
- Placebo
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov