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Taking people in United KingdomPhase 3

Tests remibrutinib in people with secondary progressive multiple sclerosis

Tests remibrutinib against placebo in adults with secondary progressive multiple sclerosis.

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Brighton, Bristol, Coventry, Glasgow, Leeds, London, Nottingham, Romford, and Stoke-on-Trent, United KingdomSee the 9 sitesAlso in 35 other countries, 244 sites
Registry title
A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
Status
Recruiting
Phase
Phase 3
People taking part
1,275 people, planned
Started
11 Nov 2025
Expected to end
2 Jan 2034
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Remibrutinib (blinded)
  • Placebo
  • Remibrutinib (Open label)
Record updated
13 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 with secondary progressive multiple sclerosis (SPMS) whose disability has been getting worse and who have had no relapses in the past 24 months.

Age
18 to 65 years
Sex
Women and men can join.
Disease stage
Secondary progressive multiple sclerosis (SPMS), diagnosed by the 2017 McDonald criteria. EDSS score of 3.0 to 6.0. No documented relapses in the 24 months before screening. Documented worsening of disability in the 12 months before screening.
Earlier treatment
People who used certain medicines listed in the protocol before screening cannot join.

Main reasons for not taking part

  • Cannot or will not have MRI scans
  • History of serious central nervous system disease, or conditions that can look like multiple sclerosis
  • Ongoing drug or alcohol abuse, or another factor, such as a serious psychiatric condition, that could get in the way of following the trial
  • History of confirmed progressive multifocal leukoencephalopathy (PML) or symptoms like PML
  • Significant bleeding risk or blood clotting disorder

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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))
  • Use of exclusionary medication prior to Screening/randomization as listed in the protocol; Other protocol-defined inclusion/exclusion critria may apply
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?
  • Which type of multiple sclerosis (MS) has your doctor told you that you have?
  • In the past 2 years, have you had a relapse (a flare-up of new or worse MS symptoms)?
  • Can you have MRI scans (scans that use strong magnets)?

Where in United Kingdom

Also in 35 other countries, 244 sites

  • Brighton, East SussexHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
  • BristolHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
  • CoventryHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
  • GlasgowHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
  • Leeds, West YorkshireHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
  • LondonHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
  • NottinghamHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
  • Romford, EssexHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
  • Stoke-on-TrentHospital not named in the registryContact: Novartis PharmaceuticalsTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Remibrutinib (LOU064)Treatment being tested

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

    Treatment: Remibrutinib (blinded) and Remibrutinib (Open label)

  • PlaceboPlacebo, for comparison

    Core Part: Matching placebo film-coated tablet taken orally \[Extension Part: Open-label remibrutinib film-coated tablet taken orally\]

    Treatment: Placebo and Remibrutinib (Open label)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Tests remibrutinib in people with secondary progressive multiple sclerosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07225504, who can take part
Record updated
13 October 2026