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

What this study is about

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

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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), 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 < 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

Where this trial is running

• Alabama Neurology Associates PC, Birmingham, Alabama, United States
• Ctr for Neurology and Spine, Phoenix, Arizona, United States
• AZ Integrated Neuro and Spine, Phoenix, Arizona, United States
• Center for Neurosciences, Tucson, Arizona, United States
• Fullerton Neuro and Headache Ctr, Fullerton, California, United States
• Regina Berkovich MD PhD Inc, West Hollywood, California, United States
• Georgetown University Hospital, Washington D.C., District of Columbia, United States
• Medstar Washington Hosp Ctr, Washington D.C., District of Columbia, United States
• Neurology of Central FL Res Ctr, Altamonte Springs, Florida, United States
• UF Health Cancer Center, Gainesville, Florida, United States
• Homestead Assoc In Research Inc, Homestead, Florida, United States
• Neurology Associates PA, Maitland, Florida, United States

+ 211 more sites.

Who to contact

Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07225504.