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

NCT ID: NCT07225504

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2034-01-02

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. Approximately 1275 eligible participants will be randomized to receive either remibrutinib or matching placebo.

The study consists of an event-driven Core Part with double-blind treatment, followed by an Extension Part with open-label remibrutinib treatment.

Conditions

Secondary Progressive Multiple Sclerosis (SPMS)

Keywords

MS; Multiple sclerosis; secondary progressive multiple sclerosis; SPMS; remibrutinib; LOU064; adult; Expanded Disability Status Scale; EDSS; McDonald diagnostic criteria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Remibrutinib (LOU064)

Core Part: Remibrutinib film-coated tablet taken orally

[Extension Part: Open-label remibrutinib film-coated tablet taken orally]

Group Type: EXPERIMENTAL

Remibrutinib (blinded)

Intervention Type: DRUG

Remibrutinib (Blinded) active treatment, oral tablet

Remibrutinib (Open label)

Intervention Type: DRUG

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]

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo (binded), oral tablet

Remibrutinib (Open label)

Intervention Type: DRUG

Remibrutinib (Open Label), oral tablet

Interventions

Remibrutinib (blinded)

Remibrutinib (Blinded) active treatment, oral tablet

Intervention Type: DRUG

Placebo

Matching placebo (binded), oral tablet

Intervention Type: DRUG

Remibrutinib (Open label)

Remibrutinib (Open Label), oral tablet

Intervention Type: DRUG

Other Intervention Names

LOU064; LOU064

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Novartis Pharmaceuticals

Role: CONTACT

Phone: 1-888-669-6682

Email: novartis.email@novartis.com

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Other Identifiers

CLOU064P12301

Identifier Type: -

Identifier Source: org_study_id