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.

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 Sjögren's Syndrome

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 612 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 \[NCT05349214\]).

Detailed description

This is a multicenter, randomized, double-blind, followed by an open-label, phase 3 study to assess the long-term safety and tolerability of of 300 mg ianalumab s.c. injection in participants with Sjögren's syndrome who have taken part in and completed one of two NEPTUNUS core studies, NEPTUNUS-1 (CVAY736A2301) or NEPTUNUS-2 (CVAY736A2302). There will be no screening period in this trial. From Week 48 of the NEPTUNUS core study, participants will be given the opportunity to consent to this extension study. Eligible participants will enter the double blind treatment period and receive ianalumab 300 mg either monthly or every three months, consistent with their prior treatment assignment. Participants previously randomized to placebo in the core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or every three months, starting at Week 60. Participants assigned to every three month dosing will receive monthly placebo injections between active doses to maintain blinding. The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe (PFS) in needle safety device for injection or ianalumab via 2 mL autoinjector (AI). An AI is a device constituent of a single integral, or single entity, drug-device combination product, with drug primary mode of action. Participants already enrolled into the study (before AI approval and implementation) will continue receiving the treatment via PFS and will not be switched to AI. All participants, including those previously on ianalumab 300 mg every three months or monthly in the double-blind treatment period will switch to open-label treatment and receive ianalumab 300 mg monthly. The treatment duration including both double-blind and open-label treatment periods will be 6 years. After the treatment period, all participants will enter a follow-up period to be monitored for at least 20 weeks and then a conditional (if B-cell recovery criteria have not been met) follow-up period. The total post treatment follow-up period is up to 2 years. The total duration of this extension study will be up to 8 years.

Conditions

• Sjogrens Syndrome

Interventions

Type	Name	Description
DRUG	Ianalumab (VAY736)	Ianalumab 300 mg / 2 mL, PFS or AI, monthly or every 3 months, solution for injection for subcutaneous use
OTHER	Placebo	Placebo 0 mg/2 mL PFS or AI, once monthly between doses of Ianalumab 3 monthly , solution for injection for subcutaneous Use

Timeline

• Start date: 2023-10-27
• Primary completion: 2033-04-22
• Completion: 2033-04-22
• First posted: 2023-08-14
• Last updated: 2026-03-23

Locations

197 sites across 35 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Japan, Lithuania, Mexico, Poland, Portugal, Romania, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study