Back to search results

Remibrutinib for Secondary Progressive Multiple Sclerosis (SPMS)

This study is testing a drug called remibrutinib to see if it can help people with secondary progressive multiple sclerosis (SPMS). Researchers want to find out if remibrutinib is safe and effective in slowing down the progression of the disease. You might be able to join if you are between 18 and 65 years old and have been diagnosed with SPMS. The main goal is to see how long it takes for your disability to worsen over a 6-month period, as measured by a common scale (Expanded Disability Status Scale or EDSS). This study plans to include about 1275 participants. The current recruitment status is unclear.

Study design
This is a Phase III, randomized, double-blind study where participants will receive either remibrutinib or a placebo. It will involve about 1275 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your disability progression will be measured from the start of the study for up to approximately 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07225504

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

Recruiting
PHASE3Ages 18–65InterventionalTreatment
Novartis Pharmaceuticals
~1,275 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Remibrutinib (blinded)PlaceboRemibrutinib (Open label)

At a glance

Recruiting sites
256 of 256 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)
Measured over From baseline up to approximately 5 years

Conditions

Secondary Progressive Multiple Sclerosis (SPMS)

Explore related trials

Multiple Sclerosis

Where it's being run

256 sites across 118 states
France20
Florida11
Poland11
Spain10
Bulgaria8
Germany8
Israel8
Quebec6

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

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

    The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). 6mCDP is defined as an increase from baseline in EDSS sustained for at least 6 months.