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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Secondary Progressive Multiple Sclerosis (SPMS)

In brief

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

Key facts

Study ID

NCT07225504

Run by

Novartis Pharmaceuticals

People needed

1275

Starts

2025-11-11

Expected to finish

2034-01-02

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify 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), 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 it is running

• Ctr for Neurology and Spine — Phoenix, Arizona, United States (enrolling)
• AZ Integrated Neuro and Spine — Phoenix, Arizona, United States (enrolling)
• Center for Neurosciences — Tucson, Arizona, United States (enrolling)
• Fullerton Neuro and Headache Ctr — Fullerton, California, United States (enrolling)
• Regina Berkovich MD PhD Inc — West Hollywood, California, United States (enrolling)
• UC Health Neuroscience Ctr — Aurora, Colorado, United States (enrolling)
• Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Medstar Washington Hosp Ctr — Washington D.C., District of Columbia, United States (enrolling)
• Neurology of Central FL Res Ctr — Altamonte Springs, Florida, United States (enrolling)
• UF Health Cancer Center — Gainesville, Florida, United States (enrolling)
• Homestead Assoc In Research Inc — Homestead, Florida, United States (enrolling)
• Neurology Associates PA — Maitland, Florida, United States (enrolling)
• Miami NS Ins Baptist Health S FL — Miami, Florida, United States (enrolling)
• Aqualane Clinical Research — Naples, Florida, United States (enrolling)
• Orlando Health Clinical Trials — Orlando, Florida, United States (enrolling)
• Comprehensive Neurology Clinic — Orlando, Florida, United States (enrolling)
• Neurology Associates of Ormond Beach — Ormond Beach, Florida, United States (enrolling)
• Axiom Brain Health — Tampa, Florida, United States (enrolling)
• University Of South Florida — Tampa, Florida, United States (enrolling)
• Joi Life Wellness Group LLC — Smyrna, Georgia, United States (enrolling)
• Hawaii Pacific Neuroscience LLC — Honolulu, Hawaii, United States (enrolling)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
• University of Kansas Hospital — Kansas City, Kansas, United States (enrolling)
• Mid Atlantic Epilepsy and Sleep Ctr — Bethesda, Maryland, United States (enrolling)
• Alabama Neurology Associates PC — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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