Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

August 25, 2026 updated by: Novartis Pharmaceuticals

A Randomized, Open-label, Parallel-group, Non-inferiority Study Comparing Efficacy, Safety, and Tolerability of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis, Followed by Open-label Treatment With Remibrutinib

The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a randomized, open-label, non-inferiority multi-center, Phase 3b study to provide efficacy, safety, and tolerability data for remibrutinib after switching from ocrelizumab and in comparison to continuous ocrelizumab in plwRMS.

This study consists of an initial Core Part (CP) (maximum duration per participant of up to 24 months), followed by an Extension Part (EP) (of up to 24 months duration) for eligible participants.

All participants completing the 24-month treatment of the Core Part of the study may be eligible to continue in the Extension Part, an open-label, single-arm, fixed-dose design in which participants are treated with remibrutinib for up to 24 months.

The study will be conducted in the USA among other countries globally.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1055AAF
        • Recruiting
        • Novartis Investigative Site
      • Caba, Argentina, C1182
        • Recruiting
        • Novartis Investigative Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Recruiting
        • Novartis Investigative Site
      • Rosario, Santa Fe Province, Argentina, S2000BZL
        • Recruiting
        • Novartis Investigative Site
  • Australia
      • Liverpool, Australia, 2170
        • Withdrawn
        • Novartis Investigative Site
      • St Leonards, Australia, 2065
        • Recruiting
        • Novartis Investigative Site
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Novartis Investigative Site
      • Parkville, Victoria, Australia, 3050
        • Recruiting
        • Novartis Investigative Site
  • Belgium
      • Bruges, Belgium, 8000
        • Recruiting
        • Novartis Investigative Site
      • Overpelt, Belgium, 3900
        • Recruiting
        • Novartis Investigative Site
  • Brazil
    • Ceará
      • Fortaleza, Ceará, Brazil, 60120-002
        • Recruiting
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
        • Recruiting
        • Novartis Investigative Site
      • Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
        • Recruiting
        • Novartis Investigative Site
    • Santa Catarina
      • Joinville, Santa Catarina, Brazil, 89202-165
        • Recruiting
        • Novartis Investigative Site
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01244-030
        • Recruiting
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 04076-004
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2A1
        • Recruiting
        • Novartis Investigative Site
    • Quebec
      • Lévis, Quebec, Canada, G6W 0M5
        • Recruiting
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H4A 3T2
        • Recruiting
        • Novartis Investigative Site
  • Czechia
      • Brno, Czechia, 625 00
        • Recruiting
        • Novartis Investigative Site
      • Brno, Czechia, 602 00
        • Active, not recruiting
        • Novartis Investigative Site
      • Hradec Králové, Czechia, 500 05
        • Recruiting
        • Novartis Investigative Site
      • Jihlava, Czechia, 586 01
        • Recruiting
        • Novartis Investigative Site
      • Pardubice, Czechia, 532 03
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 150 06
        • Recruiting
        • Novartis Investigative Site
  • Denmark
      • Aarhus N, Denmark, 8200
        • Recruiting
        • Novartis Investigative Site
      • Glostrup Municipality, Denmark, 2600
        • Recruiting
        • Novartis Investigative Site
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Novartis Investigative Site
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • Novartis Investigative Site
      • Lille, France, 59000
        • Recruiting
        • Novartis Investigative Site
      • Marseille, France, 13885
        • Recruiting
        • Novartis Investigative Site
      • Nice, France, 06000
        • Recruiting
        • Novartis Investigative Site
      • Nîmes, France, 30029
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75940
        • Recruiting
        • Novartis Investigative Site
      • Poitiers, France, 86021
        • Recruiting
        • Novartis Investigative Site
      • Strasbourg, France, 67000
        • Recruiting
        • Novartis Investigative Site
      • Toulouse, France, 31059
        • Recruiting
        • Novartis Investigative Site
      • Tours, France, 37044
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Novartis Investigative Site
      • Bochum, Germany, 44791
        • Recruiting
        • Novartis Investigative Site
      • Erbach im Odenwald, Germany, 64711
        • Recruiting
        • Novartis Investigative Site
      • Essen, Germany, 45147
        • Recruiting
        • Novartis Investigative Site
      • Greifswald, Germany, 17475
        • Recruiting
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Recruiting
        • Novartis Investigative Site
      • Münster, Germany, 48149
        • Recruiting
        • Novartis Investigative Site
      • Ulm, Germany, 89081
        • Recruiting
        • Novartis Investigative Site
      • Ulm, Germany, 89073
        • Recruiting
        • Novartis Investigative Site
  • Greece
      • Chaïdári, Greece, 124 62
        • Recruiting
        • Novartis Investigative Site
      • Larissa, Greece, 411 10
        • Recruiting
        • Novartis Investigative Site
      • Thessaloniki, Greece, 53246
        • Recruiting
        • Novartis Investigative Site
  • Italy
    • BG
      • Bergamo, BG, Italy, 24127
        • Recruiting
        • Novartis Investigative Site
    • FG
      • Foggia, FG, Italy, 71122
        • Recruiting
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italy, 16132
        • Recruiting
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20132
        • Recruiting
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Recruiting
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00133
        • Recruiting
        • Novartis Investigative Site
      • Roma, RM, Italy, 00168
        • Recruiting
        • Novartis Investigative Site
  • Mexico
      • Mexico City, Mexico, 14050
        • Recruiting
        • Novartis Investigative Site
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06700
        • Recruiting
        • Novartis Investigative Site
  • Portugal
      • Braga, Portugal, 4710243
        • Recruiting
        • Novartis Investigative Site
      • Coimbra, Portugal, 3004-561
        • Recruiting
        • Novartis Investigative Site
      • Lisbon, Portugal, 1169-050
        • Recruiting
        • Novartis Investigative Site
  • Slovakia
    • Slovakia
      • Bratislava, Slovakia, Slovakia, 826 06
        • Recruiting
        • Novartis Investigative Site
      • Trnava, Slovakia, Slovakia, 917 02
        • Recruiting
        • Novartis Investigative Site
  • South Africa
      • Pretoria, South Africa, 0041
        • Recruiting
        • Novartis Investigative Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7405
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Novartis Investigative Site
      • Córdoba, Spain, 14004
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28222
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28009
        • Recruiting
        • Novartis Investigative Site
      • Málaga, Spain, 29010
        • Recruiting
        • Novartis Investigative Site
      • Seville, Spain, 41009
        • Recruiting
        • Novartis Investigative Site
      • Valencia, Spain, 46026
        • Recruiting
        • Novartis Investigative Site
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Novartis Investigative Site
    • Valencia
      • Valencia, Valencia, Spain, 46017
        • Recruiting
        • Novartis Investigative Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Novartis Investigative Site
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Novartis Investigative Site
      • Zurich, Switzerland, 8091
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • Leeds, United Kingdom, LS1 3EX
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, W6 8RF
        • Recruiting
        • Novartis Investigative Site
      • Swansea, United Kingdom, SA6 6NL
        • Recruiting
        • Novartis Investigative Site
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85253
    • California
      • Irvine, California, United States, 92697
        • Recruiting
        • University of California Irvine
        • Principal Investigator:
          • Michael Sy
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010-2975
        • Recruiting
        • Medstar Washington Hospital Center
        • Principal Investigator:
          • Brian Barry
        • Contact:
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • Recruiting
        • Neurology of Central FL Res Ctr
        • Principal Investigator:
          • Alicia V Cabrera
        • Contact:
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida
        • Principal Investigator:
          • Torge Rempe
        • Contact:
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Healthcare System
        • Principal Investigator:
          • Buse Sengul
        • Contact:
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Neurology Associates PA
        • Principal Investigator:
          • William David Honeycutt
        • Contact:
      • Miami, Florida, United States, 33144
      • Naples, Florida, United States, 34105
        • Recruiting
        • Aqualane Clinical Research
        • Principal Investigator:
          • Matthew J Baker
        • Contact:
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Advent Health Orlando
        • Principal Investigator:
          • Anita Fletcher
        • Contact:
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Clinical Trials
        • Principal Investigator:
          • Amparo Gutierrez
        • Contact:
      • Tallahassee, Florida, United States, 32308
        • Recruiting
        • Tallahassee Neurological Clinic
        • Principal Investigator:
          • Winston Ortiz
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • University of South Florida
        • Principal Investigator:
          • John Ciotti
        • Contact:
      • Vero Beach, Florida, United States, 32960
        • Recruiting
        • Vero Beach Neurology
        • Principal Investigator:
          • Stuart Shafer
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
        • Principal Investigator:
          • Veronica Cipriani
      • Chicago, Illinois, United States, 60607
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Hospital
        • Principal Investigator:
          • Sharon Lynch
        • Contact:
    • Maryland
      • Olney, Maryland, United States, 20832
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Withdrawn
        • Tufts Medical Center
      • Burlington, Massachusetts, United States, 01805
        • Recruiting
        • Lahey Hospital and Medical Center
        • Principal Investigator:
          • Dan Michael Pineda
        • Contact:
      • Foxborough, Massachusetts, United States, 02035
        • Recruiting
        • Neurology Center of New England PC
        • Principal Investigator:
          • Salvatore Napoli
        • Contact:
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Michigan Institute of Neurological
        • Principal Investigator:
          • Martin Belkin
        • Contact:
      • Owosso, Michigan, United States, 48867
        • Recruiting
        • Memorial HC Ins for Neuroscience
        • Principal Investigator:
          • Robert Joseph Pace
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • WA Uni School Of Med
        • Principal Investigator:
          • Matthew R Brier
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Cleveland Clinic Foundation
        • Principal Investigator:
          • Carrie M Hersh
        • Contact:
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Recruiting
        • Holy Name Medical Center
        • Principal Investigator:
          • Mary Ann Picone
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • Recruiting
        • University of New Mexico
        • Principal Investigator:
          • Clotilde Hainline
        • Contact:
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • SUNY Buffalo The Jacobs Neuro Inst
        • Contact:
        • Principal Investigator:
          • Bianca Weinstock-Guttman
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
    • North Dakota
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Centerville, Ohio, United States, 45459
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Univ of Cincinnati Medical Center
        • Principal Investigator:
          • Aram Zabeti
        • Contact:
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Principal Investigator:
          • Devon Conway
        • Contact:
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Ohio Health Research Institute
        • Principal Investigator:
          • Jacqueline Nicholas
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Neurological Services West
        • Contact:
        • Principal Investigator:
          • Jessica Rice
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Premier Neurology
        • Principal Investigator:
          • Mary Denise Hughes
        • Contact:
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • Recruiting
        • Sibyl Wray MD Neurology PC
        • Principal Investigator:
          • Sibyl Wray
        • Contact:
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Austin Regional Clinic
        • Principal Investigator:
          • Diana Andino
        • Contact:
      • Dallas, Texas, United States, 75390-9034
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • John Peter Smith Hospital
        • Principal Investigator:
          • Horacio Chiong-Rivero
        • Contact:
      • Plano, Texas, United States, 75024
        • Recruiting
        • Saturn Research Solutions LLC
        • Principal Investigator:
          • Annette Okai
        • Contact:
    • Virginia
      • Richmond, Virginia, United States, 23298-0111
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • Ryan Canissario
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228-1321
        • Recruiting
        • Center for Neurological Disorders G
        • Principal Investigator:
          • Bhupendra Khatri
        • Contact:
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • Ahmed Obeidat
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Male or female aged 40 to 70 years (inclusive)
  • Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
  • Treated with ocrelizumab according to routine clinical practice and at standard dose
  • Neurologically stable within 30 days
  • Suitable to be switched to remibrutinib based on physician judgement or patient preference

Key Exclusion Criteria:

  • Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria
  • History of clinically significant Central Nervous System disease or neurological disorders
  • History of confirmed Progressive Multifocal Leukoencephalopathy or neurological symptoms consistent
  • Active clinically significant systemic bacterial, viral, parasitic or fungal infections
  • Active, chronic disease of the immune system other than MS
  • Severe cardiac disease or significant findings on the ECG
  • Participant who is unable to undergo MRI scans
  • History of life-threatening infusion or injection reaction related to ocrelizumab
  • Participants not adequately controlled on ocrelizumab (CD19+ B-cell count ≥10 cells/µL at screening)

Other inclusion and exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remibrutinib Core
Remibrutinib tablet taken orally
Drug: Remibrutinib oral treatment
Remibrutinib tablet taken daily
Other Names:
  • LOU064
Active Comparator: Ocrelizumab Core
Ocrelizumab at standard dose and route of administration (i.v. or s.c) per label
Drug: Ocrelizumab
Ocrelizumab 600mg infusion or 920mg injection
Experimental: Remibrutinib Extension
Remibrutinib tablet taken orally
Drug: Remibrutinib oral treatment
Remibrutinib tablet taken daily
Other Names:
  • LOU064
Experimental: Remibrutinib Extension (Ocrelizumab in Core)
Remibrutinib tablet taken orally
Drug: Remibrutinib oral treatment
Remibrutinib tablet taken daily
Other Names:
  • LOU064

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized rate of new or enlarging T2 lesions_Core Part
Time Frame: Baseline up to month 24
Number of new/enlarging T2 lesions per year on MRI at month 24 (relative to baseline)
Baseline up to month 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events (AEs) and serious adverse events (SAEs)_Core Part
Time Frame: Baseline up to month 24
Adverse events will be collected throughout the trial. Any safety assessment findings such as laboratory, vital signs, electrocardiogram data that are considered clinically significant or meet the protocol definition of an adverse event will be reported as adverse event or serious adverse event, as appropriate
Baseline up to month 24
Annualized rate of new or enlarging T2 lesions_Extension Part
Time Frame: Month 24 up to month 48
Number of new/enlarging T2 lesions per year on MRI
Month 24 up to month 48
Number of Adverse events and serious adverse events_Extension Part
Time Frame: Month 24 up to month 48
Adverse events will be collected throughout the trial. Any safety assessment findings such as laboratory, vital signs, electrocardiogram data that are considered clinically significant or meet the protocol definition of an adverse event will be reported as adverse event or serious adverse event, as appropriate
Month 24 up to month 48
Participants with no evidence of disease activity-3 (NEDA-3)_Core Part
Time Frame: Baseline up to month 24
Participants with no evidence of disease activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6-month confirmed disability progression (6mCDP) and new/enlarging T2 lesions on MRI
Baseline up to month 24
Participants with no evidence of disease activity-3 (NEDA-3)_Extension Part
Time Frame: Month 24 up to month 48
Participants with no evidence of disease activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6-month confirmed disability progression (6mCDP) and new/enlarging T2 lesions on MRI
Month 24 up to month 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2025

Primary Completion (Estimated)

July 25, 2029

Study Completion (Estimated)

June 25, 2031

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 26, 2025

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLOU064C12306
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2023-509275-17 (Other Identifier: EU CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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