drugset / Trial / NCT07621809

Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden

NCT07621809

Phase 3 Recruiting 570 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.

Timeline

Start
2026-07-15
Primary completion
2029-08-13
Completion
2033-08-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ianalumab Monoclonal antibody 300 mg Subcutaneous

Indications