Status:
RECRUITING
A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Secondary Progressive Multiple Sclerosis (SPMS)
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
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. ...
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 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:
- 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
Key Trial Info
Start Date :
November 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 2 2034
Estimated Enrollment :
1275 Patients enrolled
Trial Details
Trial ID
NCT07225504
Start Date
November 11 2025
End Date
January 2 2034
Last Update
April 6 2026
Active Locations (90)
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1
Alabama Neurology Associates PC
Birmingham, Alabama, United States, 35209
2
AZ Integrated Neuro and Spine
Phoenix, Arizona, United States, 85037
3
Center for Neurosciences
Tucson, Arizona, United States, 85718
4
Fullerton Neuro and Headache Ctr
Fullerton, California, United States, 92835