Recruiting NCT07225504

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

Phase III Interventional Secondary Progressive Multiple Sclerosis (SPMS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Remibrutinib (blinded), Placebo, Remibrutinib (Open label).
Who it may be relevant to: Registry conditions: Secondary Progressive Multiple Sclerosis (SPMS). Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +27
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis

Overview

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.

Interventions

Drug Remibrutinib (blinded)
Remibrutinib (Blinded) active treatment, oral tablet
Drug Placebo
Matching placebo (binded), oral tablet
Drug Remibrutinib (Open label)
Remibrutinib (Open Label), oral tablet

Primary outcome measures

Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS) [Time frame: From baseline up to approximately 5 years]

Secondary outcome measures (8)

Time to 3-month confirmed disability progression (3mCDP) on EDSS [Time frame: From baseline up to approximately 5 years]
Time to 6-month confirmed disability improvement (6mCDI) on EDSS [Time frame: From baseline up to approximately 5 years]
Time to 3-month worsening by at least 20% in Timed 25-Foot Walk (T25FW) [Time frame: From baseline up to approximately 5 years]
Time to 3-month worsening by at least 20% in 9-Hole Peg Test (9-HPT) [Time frame: From baseline up to approximately 5 years]
Annualized rate of new or enlarging T2 lesions [Time frame: From baseline up to approximately 5 years]
Annualized rate of brain atrophy [Time frame: From baseline up to approximately 5 years]
Time to 6-month worsening by at least 4 points in Symbol Digit Modalities Test (SDMT) [Time frame: From baseline up to approximately 5 years]
Number of participants with Adverse events and Serious adverse events (SAE) [Time frame: From baseline up to approximately 5 years]

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 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.

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), 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment