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 (89) 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
Alabama
Alabama Neurology Associates PC
RECRUITING
Birmingham
Arizona
AZ Integrated Neuro and Spine
RECRUITING
Phoenix
Center for Neurosciences
RECRUITING
Tucson
California
Fullerton Neuro and Headache Ctr
RECRUITING
Fullerton
Regina Berkovich MD PhD Inc
RECRUITING
West Hollywood
Washington, D.c.
Georgetown University Hospital
RECRUITING
Washington D.c.
Florida
Neurology of Central FL Res Ctr
RECRUITING
Altamonte Springs
UF Health Cancer Center
RECRUITING
Gainesville
Aqualane Clinical Research
RECRUITING
Naples
Comprehensive Neurology Clinic
RECRUITING
Orlando
Orlando Health Clinical Trials
RECRUITING
Orlando
Neurology Associates of Ormond Beach
RECRUITING
Ormond Beach
Axiom Brain Health
RECRUITING
Tampa
Hawaii
Hawaii Pacific Neuroscience LLC
RECRUITING
Honolulu
Kansas
University of Kansas Hospital
RECRUITING
Kansas City
Maryland
Mid Atlantic Epilepsy and Sleep Ctr
RECRUITING
Bethesda
Michigan
Michigan Institute of Neurological
RECRUITING
Farmington Hills
Tennessee
Neurology Clinic PC
RECRUITING
Cordova
Texas
Saturn Research Solution
RECRUITING
Plano
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Buenos Aires
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Santiago Del Estero
Australia
Novartis Investigative Site
RECRUITING
Clayton
Novartis Investigative Site
RECRUITING
Heidelberg
Novartis Investigative Site
RECRUITING
Kogarah
Novartis Investigative Site
RECRUITING
New Lambton Heights
Novartis Investigative Site
RECRUITING
Westmead
Bulgaria
Novartis Investigative Site
RECRUITING
Pleven
Novartis Investigative Site
RECRUITING
Sofia
Novartis Investigative Site
RECRUITING
Sofia
Novartis Investigative Site
RECRUITING
Sofia
Canada
Novartis Investigative Site
RECRUITING
Lévis
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Sherbrooke
Novartis Investigative Site
RECRUITING
Vancouver
China
Novartis Investigative Site
RECRUITING
Chongqing
Novartis Investigative Site
RECRUITING
Hangzhou
Novartis Investigative Site
RECRUITING
Hohhot
Novartis Investigative Site
RECRUITING
Shanghai
Novartis Investigative Site
RECRUITING
Suzhou
Novartis Investigative Site
RECRUITING
Tianjin
Novartis Investigative Site
RECRUITING
Wenzhou
Novartis Investigative Site
RECRUITING
Wuhan
Colombia
Novartis Investigative Site
RECRUITING
Medellín
Novartis Investigative Site
RECRUITING
Medellín
France
Novartis Investigative Site
RECRUITING
Ajaccio
Novartis Investigative Site
RECRUITING
Amiens
Novartis Investigative Site
RECRUITING
Clermont-ferrand
Novartis Investigative Site
RECRUITING
Gonesse
Novartis Investigative Site
RECRUITING
Grenoble
Novartis Investigative Site
RECRUITING
Lille
Novartis Investigative Site
RECRUITING
Lille
Novartis Investigative Site
RECRUITING
Montpellier
Novartis Investigative Site
RECRUITING
Nice
Novartis Investigative Site
RECRUITING
Nîmes
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Poitiers
Novartis Investigative Site
RECRUITING
Tours
Germany
Novartis Investigative Site
RECRUITING
Freiburg Im Breisgau
Novartis Investigative Site
RECRUITING
Halle
Hungary
Novartis Investigative Site
RECRUITING
Budapest
Novartis Investigative Site
RECRUITING
Kistarcsa
India
Novartis Investigative Site
RECRUITING
Gurugram
Novartis Investigative Site
RECRUITING
Hyderabad
Novartis Investigative Site
RECRUITING
Kochi
Novartis Investigative Site
RECRUITING
Mangalore
Novartis Investigative Site
RECRUITING
New Delhi
Novartis Investigative Site
RECRUITING
Vellore
Israel
Novartis Investigative Site
RECRUITING
Jerusalem
Novartis Investigative Site
RECRUITING
Ramat Gan
Novartis Investigative Site
RECRUITING
Rehovot
Novartis Investigative Site
RECRUITING
Tel Aviv
Novartis Investigative Site
RECRUITING
Ẕerifin
Italy
Novartis Investigative Site
RECRUITING
Foggia
Portugal
Novartis Investigative Site
RECRUITING
Braga
Novartis Investigative Site
RECRUITING
Lisbon
Romania
Novartis Investigative Site
RECRUITING
Bucharest
Novartis Investigative Site
RECRUITING
Campulung Muscel
South Africa
Novartis Investigative Site
RECRUITING
Cape Town
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
L'hospitalet De Llobregat
Novartis Investigative Site
RECRUITING
Málaga
Novartis Investigative Site
RECRUITING
Salamanca
Novartis Investigative Site
RECRUITING
Valencia
Switzerland
Novartis Investigative Site
RECRUITING
Bern
Novartis Investigative Site
RECRUITING
Lausanne
United Kingdom
Novartis Investigative Site
RECRUITING
Glasgow
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