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A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Secondary Progressive Multiple Sclerosis (SPMS)

Interventions: Remibrutinib (blinded), Placebo, Remibrutinib (Open label)

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (236)

Birmingham, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Fullerton, California, United States
West Hollywood, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Altamonte Springs, Florida, United States
Gainesville, Florida, United States
Homestead, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Smyrna, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Bethesda, Maryland, United States
Foxborough, Massachusetts, United States
Wellesley, Massachusetts, United States
Worchester, Massachusetts, United States
Farmington Hills, Michigan, United States
Albuquerque, New Mexico, United States
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