NCT05350072

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

A Randomized, Double-blind, Placebo Controlled, 2-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-1)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-1)

Detailed description

Two-arm study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjogren's syndrome. The purpose of the study is to demonstrate the clinical efficacy, safety and tolerability of ianalumab (VAY736) administered subcutaneously (s.c.) monthly 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: 2022-07-28
• Primary completion: 2025-05-07
• Completion: 2027-05-06
• First posted: 2022-04-27
• Last updated: 2026-03-11

Locations

78 sites across 18 countries: United States, Austria, Belgium, Brazil, Chile, China, Czechia, France, Germany, Guatemala, Lithuania, Mexico, Poland, Portugal, Singapore, South Korea, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study