drugset / Trial / NCT05985915

A Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

NCT05985915

Phase 3 Active not recruiting 612 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjögren's syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 \[NCT05350072\] or CVAY736A2302 \[NCT05349214\]).

Timeline

Start
2023-10-27
Primary completion
2033-04-22
Completion
2033-04-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Ianalumab Monoclonal antibody 300 mg Subcutaneous

Indications