Clinical Trial: A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.
Study Status: Completed
Recruit Status: RECRUITING
Condition: Sjogrens Syndrome
Study Type: INTERVENTIONAL
Official Title: A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.
Brief Summary:
The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjogrens syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 or CVAY736A2302).The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe for injection.All participants will receive ianalumab either monthly or every 3 months.The treatment duration will be 3 years with an additional up to 2-year safety follow-up.The total duration of this…
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