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
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
AZ Integrated Neuro and Spine
RECRUITING
Phoenix
Florida
Neurology of Central FL Res Ctr
RECRUITING
Altamonte Springs
Orlando Health Clinical Trials
RECRUITING
Orlando
Neurology Associates of Ormond Beach
RECRUITING
Ormond Beach
Tennessee
Neurology Clinic PC
RECRUITING
Cordova
Other Locations
Australia
Novartis Investigative Site
RECRUITING
Kogarah
Canada
Novartis Investigative Site
RECRUITING
Lévis
Novartis Investigative Site
RECRUITING
Sherbrooke
Israel
Novartis Investigative Site
RECRUITING
Rehovot
Novartis Investigative Site
RECRUITING
Ẕerifin
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2025-11-11
Estimated Completion Date: 2034-01-02
Participants
Target number of participants: 1275
Treatments
Experimental: Remibrutinib (LOU064)
Core Part: Remibrutinib film-coated tablet taken orally~\[Extension Part: Open-label remibrutinib film-coated tablet taken orally\]
Placebo_comparator: Placebo
Core Part: Matching placebo film-coated tablet taken orally~\[Extension Part: Open-label remibrutinib film-coated tablet taken orally\]
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals