NCT07225504

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,275 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)

Detailed description

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, parallel-group, event-driven study to evaluate the efficacy, safety and tolerability of remibrutinib in SPMS patients. Approximately 1275 eligible participants will be randomized to receive either remibrutinib or matching placebo. The study consists of an event-driven Core Part with double-blind treatment, followed by an Extension Part with open-label remibrutinib treatment.

Conditions

• Secondary Progressive Multiple Sclerosis (SPMS)

Interventions

Type	Name	Description
DRUG	Remibrutinib (blinded)	Remibrutinib (Blinded) active treatment, oral tablet
DRUG	Placebo	Matching placebo (binded), oral tablet
DRUG	Remibrutinib (Open label)	Remibrutinib (Open Label), oral tablet

Timeline

• Start date: 2025-11-11
• Primary completion: 2030-12-03
• Completion: 2034-01-02
• First posted: 2025-11-06
• Last updated: 2026-04-06

Locations

90 sites across 20 countries: United States, Argentina, Australia, Bulgaria, Canada, China, Colombia, Czechia, France, Germany, Hungary, India, Israel, Italy, Portugal, Romania, South Africa, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study