A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis
Novartis Pharmaceuticals
Summary
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Signed informed consent must be obtained prior to any assessment performed. * Male or female participants aged 18-65 (inclusive) at Screening. * Diagnosis of SPMS according to the 2017 revised McDonald criteria (Thompson et al 2018) at Screening. * Absence of documented clinical relapses in the 24 months before Screening and randomization. * EDSS score of 3.0 to 6.0 (inclusive) at Screening. * Documented evidence of disability progression in the 12 months before Screening. Exclusion Criteria: * Unwilling or unable to undergo MRI scans as per protocol (for example, clau…
Interventions
- DrugRemibrutinib (blinded)
Remibrutinib (Blinded) active treatment, oral tablet
- DrugPlacebo
Matching placebo (binded), oral tablet
- DrugRemibrutinib (Open label)
Remibrutinib (Open Label), oral tablet
Locations (164)
- Alabama Neurology Associates PCBirmingham, Alabama
- AZ Integrated Neuro and SpinePhoenix, Arizona
- Center for NeurosciencesTucson, Arizona
- Fullerton Neuro and Headache CtrFullerton, California
- Regina Berkovich MD PhD IncWest Hollywood, California
- Georgetown University HospitalWashington D.C., District of Columbia