A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
NCT ID: NCT07225504
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1275 participants
INTERVENTIONAL
2025-11-11
2034-01-02
Brief Summary
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Detailed Description
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The study consists of an event-driven Core Part with double-blind treatment, followed by an Extension Part with open-label remibrutinib treatment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Remibrutinib (LOU064)
Core Part: Remibrutinib film-coated tablet taken orally
\[Extension Part: Open-label remibrutinib film-coated tablet taken orally\]
Remibrutinib (blinded)
Remibrutinib (Blinded) active treatment, oral tablet
Remibrutinib (Open label)
Remibrutinib (Open Label), oral tablet
Placebo
Core Part: Matching placebo film-coated tablet taken orally
\[Extension Part: Open-label remibrutinib film-coated tablet taken orally\]
Placebo
Matching placebo (binded), oral tablet
Remibrutinib (Open label)
Remibrutinib (Open Label), oral tablet
Interventions
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Remibrutinib (blinded)
Remibrutinib (Blinded) active treatment, oral tablet
Placebo
Matching placebo (binded), oral tablet
Remibrutinib (Open label)
Remibrutinib (Open Label), oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Alabama Neurology Associates PC
Birmingham, Alabama, United States
AZ Integrated Neuro and Spine
Phoenix, Arizona, United States
Neurology of Central FL Res Ctr
Altamonte Springs, Florida, United States
Orlando Health Clinical Trials
Orlando, Florida, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States
Neurology Clinic PC
Cordova, Tennessee, United States
Novartis Investigative Site
Kogarah, New South Wales, Australia
Novartis Investigative Site
Lévis, Quebec, Canada
Novartis Investigative Site
Sherbrooke, Quebec, Canada
Novartis Investigative Site
Rehovot, , Israel
Novartis Investigative Site
Tel Aviv, , Israel
Novartis Investigative Site
Ẕerifin, , Israel
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Phone: +41613241111
Facility Contacts
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Virginia Weinacker
Role: primary
Brandon McCravey
Role: primary
Adiana Perez
Role: primary
Charlene Carlo
Role: primary
Heather Schutz
Role: primary
Ye Liu
Role: primary
Other Identifiers
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2025-521546-23
Identifier Type: OTHER
Identifier Source: secondary_id
CLOU064P12301
Identifier Type: -
Identifier Source: org_study_id