A randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis

This study wants to know how well the study drug, remibrutinib, works and how safe it is compared to placebo in people with secondary progressive multiple sclerosis (SPMS).


Why this Research Matters

Multiple sclerosis (MS) is a disease where the body's immune system attacks the brain and spinal cord. Common symptoms are fatigue, numbness or tingling, muscle stiffness or lack of strength, and trouble walking. The study will learn the effects of remibrutinib on people with SPMS and understand if being treated with remibrutinib will slow down the progression of your SPMS.This study will ask you to participate in study activities during a core period of up to 5 years with participants in a double-blind treatment (receiving either remibrutinib or placebo) then followed by an extension period of up to 3 years with open-label remibrutinib treatment.


Who can Participate

Adult

You may be able to join the study if you are an adult aged between 18-65 years old with a SPMS diagnosis that have a documentation of disability progression in the last 12 months and do not have documentation of a clinical relapse in the last 24 months.


Study ID

Protocol Number: 25-2134

More information available at ClinicalTrials.gov: NCT07225504


Meet the Team

Image of Principal Investigator

Enrique Alvarez, MD, PhD

Principal Investigator