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Looking for participantsPhase3

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

Sponsor: Novartis Pharmaceuticals

NCT ID: NCT07225504

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Remibrutinib (blinded) (drug), Placebo (drug), Remibrutinib (Open label) (drug)
How long the study runs
Study runs about 98 months (dates as stated)
About the drug or intervention
Remibrutinib (blinded) — drug: Remibrutinib (Blinded) active treatment, oral tablet · Placebo — drug: Matching placebo (binded), oral tablet · Remibrutinib (Open label) — drug: Remibrutinib (Open Label), oral tablet
Patient visit burden
Not specified by the sponsor

In plain English

This Novartis Pharmaceuticals study is testing how well and how safely remibrutinib works in people with secondary progressive multiple sclerosis (SPMS), a form of MS where symptoms steadily get worse over time. Not stated — ask the trial team for further details about the study's aims.

Who can take part

  • Adults aged 18 to 65 who have given informed consent
  • A diagnosis of MS and current secondary progressive MS at screening
  • No relapses (flare-ups) in the 24 months before screening
  • An EDSS (disability scale) score between 3.0 and 6.0 at screening
  • Evidence that disability has got worse in the 12 months before screening

Who may not be able to

  • People unable or unwilling to have MRI scans (for example due to claustrophobia, a pacemaker, or certain metal implants)
  • History of significant brain or spinal conditions, or other neurological conditions that could look like MS
  • Ongoing drug or alcohol misuse, or other factors (such as a serious mental health condition) that could affect taking part
  • History of, or symptoms of, progressive multifocal leukoencephalopathy (PML), a rare brain infection
  • Women who could become pregnant, unless using highly effective contraception during treatment and for at least 1 week after stopping
  • Significant bleeding risk or blood clotting disorders at screening
  • Taking certain medicines before screening or joining, as listed in the study protocol

What taking part involves

  • • Taking the study medicine remibrutinib — not stated — ask the trial team about how it is taken, the dose, and whether there is a placebo (dummy) group
  • • Having MRI scans as part of the study
  • • Contraception for women who could become pregnant, during treatment and for at least 1 week after stopping

Time commitment: Not stated — ask the trial team about how long the study lasts, how many visits are needed, and what else taking part would involve.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 65 Years
Who
All
Number of participants
1,275
Started
2025-11-11
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for secondary progressive multiple sclerosis (spms)
  • • Phase3 - 1,275 participants
  • • The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)

Who can take part?

  • • Ages 18 Years to 65 Years
  • • Diagnosed with secondary progressive multiple sclerosis (spms)

Where?

  • • Brighton - Novartis Investigative Site
  • • Romford - Novartis Investigative Site
  • • Coventry - Novartis Investigative Site
  • • Glasgow - Novartis Investigative Site
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)

More detail

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.

Secondary Progressive Multiple Sclerosis (SPMS)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 65 Years
  • Who can join: All genders

What the study is looking for

  • ✓Signed agreement to take part 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...
  • ✓Absence of documented clinical relapses in the 24 months before Screening and randomization.
  • ✓EDSS score of 3.0 to 6.0 (inclusive) at Screening.

Who cannot take part

  • ✗Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may...
  • ✗Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms...
  • ✗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
See the full 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

Where Is This Study? (7 UK sites)

Novartis Investigative Site

Brighton BN2 5BE, United Kingdom

Recruiting

Novartis Investigative Site

Romford RM7 0AG, United Kingdom

Recruiting

Novartis Investigative Site

Coventry CV2 2DX, United Kingdom

Recruiting

Novartis Investigative Site

Glasgow EH9 1LF, United Kingdom

Recruiting

Novartis Investigative Site

Leeds LS1 3EX, United Kingdom

Recruiting

Novartis Investigative Site

London E1 2AT, United Kingdom

Recruiting

Novartis Investigative Site

Nottingham NG7 2UH, United Kingdom

Recruiting

How to Get in Touch

Novartis Pharmaceuticals

Sponsor contact

CONTACT

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

Sponsor contact

CONTACT

+41613241111
Data sourced from ClinicalTrials.gov · Last verified: 2026-07