NCT05349214

Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

A Randomized, Double-blind, Placebo Controlled, 3-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-2)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 506 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)

Detailed description

Three-arm study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjogren's syndrome. The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of ianalumab (VAY736) administered subcutaneously (s.c.) monthly or every 3 months compared to placebo in patients with active Sjogren's syndrome.

Conditions

• Sjogren Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	VAY736	ianalumab s.c.
OTHER	Placebo	placebo s.c.

Timeline

• Start date: 2022-08-04
• Primary completion: 2025-05-13
• Completion: 2027-05-13
• First posted: 2022-04-27
• Last updated: 2026-03-11

Locations

146 sites across 26 countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study