Health Condition 1: G35- Multiple sclerosis
Conditions
Interventions
Intervention1: Remibrutinib: Remibrutinib film-coated tablet 100 mg b.i.d. upto 72 months
Control Intervention1: Placebo: Matching placebo film-coated
tablet 0 mg b.i.d. upto 72 months
Sponsors
Novartis Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: • Signed informed consent must be obtained prior to any assessment performed. • Male or female participants aged 18 to 65 years (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
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 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), defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate less than 1 percent 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate efficacy of remibrutinib compared to placebo in delaying disability progression based on EDSSTimepoint: Time to 6-month confirmed disability progression (6mCDP) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess whether remibrutinib is superior to placebo in: - Delaying disability progression based on EDSS - Other clinical and MRI measuresTimepoint: - Time to 3-month confirmed disability progression (3mCDP) on EDSS - Time to 6-month confirmed disability improvement (6mCDI) on EDSS - Time to 3-month worsening by at least 20 percent in Timed 25-Foot Walk (T25FW) - Time to 3-month worsening by at least 20 percent in 9-Hole Peg Test (9-HPT) - Annualized rate of new or enlarging T2 lesions - Percentage of participants with annualized rate of brain atrophy greater than 0.45 percent - Time to 6-month worsening by at least 4 points in Symbol Digit Modalities Test (SDMT);To assess the safety and tolerability of remibrutinibTimepoint: Adverse events, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating Scale (C-SSRS) from Baseline till End of Study | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Switzerland, United Kingdom, United States of America
Contacts
Public ContactMurugananthan K
Novartis Healthcare Private Limited
Outcome results
None listed