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Taking people in ItalyPhase 3

Remibrutinib compared with placebo in people with secondary progressive multiple sclerosis

Tests remibrutinib against placebo for slowing disability in secondary progressive multiple sclerosis.

Key facts

Who runs it
Novartis Pharma AG
Where
Ancona, Bergamo, Cagliari, Chieti Scalo, Foggia, Gallarate (VA), Naples, Orbassano, Pavia, Pozzilli, and Rome, ItalySee the 14 sitesAlso in 24 other countries, 170 sites
Trial code
Registry title
A clinical trial to find out how well LOU064 (remibrutinib) works and how safe it is for people with secondary progressive multiple sclerosis
Status
Recruiting
Phase
Phase 3
People taking part
677 people, planned
Started
21 Apr 2026
Expected to end
1 Jan 2034
Type of study
Interventional
Record updated
30 July 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 18-65 with secondary progressive multiple sclerosis (SPMS) and worsening disability but no recent relapses.

Age
18-65 years (inclusive)
Sex
Men and women
Disease stage
SPMS diagnosed by the 2017 revised McDonald criteria. No documented relapses in the 24 months before screening. EDSS score of 3.0 to 6.0. Documented worsening of disability in the 12 months before screening.
Earlier treatment
People who used medicines listed as excluded in the protocol before screening or randomization cannot join.

Main reasons for not taking part

  • Unwilling or unable to have MRI scans, for example claustrophobia or metal implants, pacemaker or defibrillator
  • History of serious brain or spinal cord disease, or nerve disorders that can mimic MS
  • Ongoing drug or alcohol abuse, or another factor such as a serious psychiatric condition that may stop you following the study procedures
  • History of confirmed PML (progressive multifocal leukoencephalopathy) or symptoms consistent with it
  • Significant bleeding risk or blood clotting disorders

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 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

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
  • History of clinically significant CNS disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic MS at Screening
  • 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

Check if you might fit

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

  • 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 Italy

Also in 24 other countries, 170 sites

  • Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyTaking people
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
  • Azienda Socio Sanitaria Locale N. 8 Di CagliariCagliari, ItalyTaking people
  • Universita' Degli Studi G. D'Annunzio Di ChietiChieti Scalo, ItalyTaking people
  • Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, ItalyTaking people
  • ASST della Valle Olona Presidio Ospedaliero S. Antonio Abate di GallarateGallarate (VA), ItalyTaking people
  • Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyTaking people
  • Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, ItalyTaking people
  • Fondazione Istituto Neurologico Nazionale Casimiro MondinoPavia, ItalyTaking people
  • Istituto Neurologico Mediterraneo Neuromed S.p.A.Pozzilli, ItalyTaking people
  • Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
  • Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRome, ItalyTaking people
  • Provincia Religiosa Di S.Pietro Dell' Ordine Ospedaliero Di San Giovanni Di Dio FatebenefratelliRome, ItalyTaking people

About the trial

What the trial wants to find out

To demonstrate efficacy of remibrutinib compared to placebo in delaying disability progression based on EDSS

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

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
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
Remibrutinib compared with placebo 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 9 November 2026.
Fit questions
Built from 2025-521546-23-00, who can take part
Record updated
30 July 2026