A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
Purpose
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
Condition
- Secondary Progressive Multiple Sclerosis (SPMS)
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts 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 MS according to the 2017 revised McDonald criteria (Thompson et al 2018), with current SPMS in accordance with the revised clinical course (Lublin et al 2014) 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, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)). - History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS). - Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability to cooperate and comply with the study procedures. - Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML. - Women of childbearing potential (WOCBP), unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for at least 1 week after stopping study treatment. - Significant bleeding risk or coagulation disorders, at Screening. - Use of exclusionary medication prior to Screening/randomization as listed in the protocol. Other protocol-defined inclusion/exclusion critria may apply
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Double blind on Core part and Open label on Extension part
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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] |
|
Recruiting Locations
Alabama Neurology Associates PC
Birmingham, Alabama 35209
Birmingham, Alabama 35209
Ctr for Neurology and Spine
Phoenix, Arizona 85018
Phoenix, Arizona 85018
AZ Integrated Neuro and Spine
Phoenix, Arizona 85037
Phoenix, Arizona 85037
Center for Neurosciences
Tucson, Arizona 85718
Tucson, Arizona 85718
Fullerton Neuro and Headache Ctr
Fullerton, California 92835
Fullerton, California 92835
Regina Berkovich MD PhD Inc
West Hollywood, California 90048
West Hollywood, California 90048
UC Health Neuroscience Ctr
Aurora, Colorado 80045
Aurora, Colorado 80045
Georgetown University Hospital
Washington D.C., District of Columbia 20007
Washington D.C., District of Columbia 20007
Medstar Washington Hosp Ctr
Washington D.C., District of Columbia 20010
Washington D.C., District of Columbia 20010
Neurology of Central FL Res Ctr
Altamonte Springs, Florida 32714
Altamonte Springs, Florida 32714
UF Health Cancer Center
Gainesville, Florida 32610
Gainesville, Florida 32610
Homestead Assoc In Research Inc
Homestead, Florida 33033
Homestead, Florida 33033
Neurology Associates PA
Maitland, Florida 32751
Maitland, Florida 32751
Miami NS Ins Baptist Health S FL
Miami, Florida 33176
Miami, Florida 33176
Aqualane Clinical Research
Naples, Florida 34105
Naples, Florida 34105
Orlando Health Clinical Trials
Orlando, Florida 32806
Orlando, Florida 32806
Comprehensive Neurology Clinic
Orlando, Florida 32825
Orlando, Florida 32825
Neurology Associates of Ormond Beach
Ormond Beach, Florida 32174
Ormond Beach, Florida 32174
University Of South Florida
Tampa, Florida 33612
Tampa, Florida 33612
Hawaii Pacific Neuroscience LLC
Honolulu, Hawaii 96817
Honolulu, Hawaii 96817
Northwestern Memorial Hospital
Chicago, Illinois 60611
Chicago, Illinois 60611
University of Kansas Hospital
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Mid Atlantic Epilepsy and Sleep Ctr
Bethesda, Maryland 20817-1807
Bethesda, Maryland 20817-1807
Neuro Institute of New England P C
Foxborough, Massachusetts 02035
Foxborough, Massachusetts 02035
Elliot Lewis MS Center
Wellesley, Massachusetts 02481
Wellesley, Massachusetts 02481
U Mass Memorial Medical Center
Worchester, Massachusetts 01605
Worchester, Massachusetts 01605
Michigan Institute of Neurological
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
University of New Mexico Hospital
Albuquerque, New Mexico 87106
Albuquerque, New Mexico 87106
Premier Neurology
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Neurology Consultants Of Dallas PA
Dallas, Texas 75231
Dallas, Texas 75231
University of Washington MS Clinic
Seattle, Washington 98133
Seattle, Washington 98133
Citta Clinical Research
Spokane, Washington 99202
Spokane, Washington 99202
More Details
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
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.