The study is evaluating the study drug and looking at how well it works, how it is tolerated and how safe it is for people with primary Sjogren's disease (pSjD).
This study is about two years long. It consists of following- Screening period (2 weeks) Double-blind study treatment period (48 weeks) Open-label extension (48 weeks) Safety followup period (8 weeks)
At least 18 years old, Clinical diagnosis of primary Sjogren's disease. Secondary Sjogren's disease diagnosis is excluded. Inclusion- Women of childbearing potential should agree to use contraceptive measures consistent with local regulations. Exclusion: -Any autoimmune disease that would interfere with accurate assessment of clinical symptoms of pSjD. -Active, not adequately controlled fibromyalgia, or participant who is receiving fibromyalgia treatment that has not been stable for at least 12 weeks before screening. -Any severe systemic pSjD manifestation that is not adequately controlled at baseline that may put the participant at undue risk based on the investigator's opinion. -Severe renal impairment -Comorbidities for example, asthma, chronic obstructive pulmonary disease, which have required 3 or more courses of systemic glucocorticoids within previous 12 months
Protocol Number: 25-0435
Principal Investigator