Clinical Trial

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

Study acronym: THALASSA
Recruiting Phase 3
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-10
Trial Details
NCT Number NCT07621809
Lead Sponsor Novartis Pharmaceuticals
Conditions Sjögren´s Disease
Enrollment 570 participants
Start Date 2026-07-15
Primary Completion 2029-08-13 (estimated)
Study Completion 2033-08-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-09