AzTrials
AzTrials

Relapsing Multiple SclerosisPhase 3NCT06846281

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

A Phase 3 study testing Remibrutinib oral treatment and Ocrelizumab in people with Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 131 sites in 19 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Relapsing Multiple Sclerosis
What is being tested?
Remibrutinib oral treatment and Ocrelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
131 sitesin 19 countries
Study dates
23 Jun 2025to 25 Jun 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

131 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+41613241111

131 sites in 19 countries

United States45 sites, 44 recruiting

  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001

    Emily Reese, +1 505 272 2836, ejreese@salud.unm.edu

    Clotilde Hainline

    Recruiting

  • Neurology of Central FL Res Ctr

    Altamonte Springs, Florida, 32714

    Adiana Perez, +1 407 790 4990, adiresearchcfl@gmail.com

    Alicia V Cabrera

    Recruiting

  • Austin Regional Clinic

    Austin, Texas, 78731

    Katerina Rodriguez, +1 512 344 0362, krodriguez@innovoresearch.com

    Diana Andino

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Withdrawn

  • SUNY Buffalo The Jacobs Neuro Inst

    Buffalo, New York, 14203

    Kara Patrick, kpatrick@buffalo.edu

    Bianca Weinstock-Guttman

    Recruiting

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

    Anish Panda, +1 781 744 3874, Anish.Panda@lahey.org

    Dan Michael Pineda

    Recruiting

  • Premier Health

    Centerville, Ohio, 45459

    Don McHone, djmchone@premierhealth.com

    Jon Williams

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27517

    Marleny Nolasco, nolascom@neurology.unc.edu

    Monica Maria Diaz

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60607

    Bartosz Jacher, Bartosz.Jacher@Northwestern.edu

    Allison Osen

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Cheryl Bibbs, +1 773 702 5382, cbibbs@bsd.uchicago.edu

    Veronica Cipriani

    Recruiting

  • Univ of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Gideon Gyebi, + 1 513 558 4489, gyebign@ucmail.uc.edu

    Aram Zabeti

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Dawn Maniawski, +1 216 445 5788, maniawd@ccf.org

    Devon Conway

    Recruiting

  • Ohio Health Research Institute

    Columbus, Ohio, 43214

    Megan Heckathorn, 1 614 566 1262, Megan.Heckathorn@ohiohealth.com

    Jacqueline Nicholas

    Recruiting

  • Univ of Texas Southwest Med Center

    Dallas, Texas, 75390-9034

    Manuel Huichapa, manuel.huichapa@utsouthwestern.edu

    Peter Sguigna

    Recruiting

  • Sanford Health

    Fargo, North Dakota, 58102

    Neurology Research Coordinator, 701-234-2474, clinicalresearch@sanfordhealth.org

    Scott Belliston

    Recruiting

  • Michigan Institute of Neurological

    Farmington Hills, Michigan, 48334

    Emily Blazejewski, +1 248 553 0010, eblazejewski@mindonline.com

    Martin Belkin

    Recruiting

  • John Peter Smith Hospital

    Fort Worth, Texas, 76104

    Valentina Jovic, +1 817 702 1680, Vjovic@jpshealth.org

    Horacio Chiong-Rivero

    Recruiting

  • Neurology Center of New England PC

    Foxborough, Massachusetts, 02035

    Jillian Pellegrini, +1 781 551 5812, jpellegrini@neurocenterne.com

    Salvatore Napoli

    Recruiting

  • University of Florida

    Gainesville, Florida, 32610

    Whitney Miller, wjm1433@ufl.edu

    Torge Rempe

    Recruiting

  • Center for Neurological Disorders G

    Greenfield, Wisconsin, 53228-1321

    Emily Barraza, Emily.barraza@cndmilwaukee.com

    Bhupendra Khatri

    Recruiting

  • Premier Neurology

    Greenville, South Carolina, 29605

    Anna Lares, +1 864 655 4005, anna.l@premier-neuro.com

    Mary Denise Hughes

    Recruiting

  • Memorial Healthcare System

    Hollywood, Florida, 33021

    Hina Khan, +1 954 265 6934, hikhan@mhs.net

    Buse Sengul

    Recruiting

  • University of California Irvine

    Irvine, California, 92697

    Veronica Martin, vero@hs.uci.edu

    Michael Sy

    Recruiting

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

    Vonda Whitley, +1 913 588 9600, vwhitley@kumc.edu

    Sharon Lynch

    Recruiting

  • Sibyl Wray MD Neurology PC

    Knoxville, Tennessee, 37922

    Kim Puccio, +1 865 218 6222, kpuccio@hopeneuro.com

    Sibyl Wray

    Recruiting

  • Cleveland Clinic Foundation

    Las Vegas, Nevada, 89106

    Laurinda Keelen, +1 702 483 6003, keelenl@ccf.org

    Carrie M Hersh

    Recruiting

  • Neurology Associates PA

    Maitland, Florida, 32751

    Nicole Perovic, +1 407 647 5996, nicole.naparesearch@gmail.com

    William David Honeycutt

    Recruiting

  • Elite Clinical Research

    Miami, Florida, 33144

    Rebeca Fernandez, +1 305 262 3396, rfernandez@eliteclinicalresearch.com

    Gelasio A Baras

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Anna Freiberg, +1 414 805 5249, afreiberg@mcw.edu

    Ahmed Obeidat

    Recruiting

  • Aqualane Clinical Research

    Naples, Florida, 34105

    Taylor Kerskie, +1 239 434 0332, taylor@aqualaneresearch.com

    Matthew J Baker

    Recruiting

  • MedStar Montgomery Medical Center

    Olney, Maryland, 20832

    Yemisrach Tadesse, yemisrach.g.tadesse@medstar.net

    Faria Amjad

    Recruiting

  • Advent Health Orlando

    Orlando, Florida, 32803

    McKinzie McTyeire, +1 407 303 5600, mckinzie.mctyeire@adventhealth.com

    Anita Fletcher

    Recruiting

  • Orlando Health Clinical Trials

    Orlando, Florida, 32806

    Charlene Carlo, +1 407 352 5434, Charlene.carlo@orlandohealth.com

    Amparo Gutierrez

    Recruiting

  • Memorial HC Ins for Neuroscience

    Owosso, Michigan, 48867

    Samantha Katt, skatt@memorialhealthcare.org

    Robert Joseph Pace

    Recruiting

  • Saturn Research Solutions LLC

    Plano, Texas, 75024

    Maxine Fligg, +1 972 403 8184, mfligg@saturnclinical.com

    Annette Okai

    Recruiting

  • Providence Neurological Services West

    Portland, Oregon, 97225

    Hunter Weaver, +1 503 216 1150, hunter.weaver@providence.org

    Jessica Rice

    Recruiting

  • Velocity Clinical Research

    Raleigh, North Carolina, 27607

    Harsh Patel, HPatel@velocityclinical.com

    Casey Jeffreys

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298-0111

    Aarati Pokharel, aarati.pokharel@vcuhealth.org

    Ryan Canissario

    Recruiting

  • Perseverance Research Center

    Scottsdale, Arizona, 85253

    Adriana Romero, aromero@prcresearcheducation.com

    Barry Hendin

    Recruiting

  • WA Uni School Of Med

    St Louis, Missouri, 63110

    Kiontay Watson, +1 314 362 3293, k.watson@wustl.edu

    Matthew R Brier

    Recruiting

  • Tallahassee Neurological Clinic

    Tallahassee, Florida, 32308

    Sharon Devore, +1 850 878 8121, sharondevore@hotmail.com

    Winston Ortiz

    Recruiting

  • University Of South Florida

    Tampa, Florida, 33612

    Amber McPherson, +1 813 974 9423, amjackson@usf.edu

    John Ciotti

    Recruiting

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

    Diome Kramer, dkramer@holyname.org

    Mary Ann Picone

    Recruiting

  • Vero Beach Neurology

    Vero Beach, Florida, 32960

    Clellia Bergamino, +1 772 492 7051#232, cbergamino@geodysseyrsch.com

    Stuart Shafer

    Recruiting

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010-2975

    Anu Bhooshan, +1 202 877 8946, anu.r.bhooshan@medstar.net

    Brian Barry

    Recruiting

Other trials in United States

France11 sites, 11 recruiting

  • Novartis Investigative Site

    Bordeaux, 33076

    Recruiting

  • Novartis Investigative Site

    Clermont-Ferrand, 63003

    Recruiting

  • Novartis Investigative Site

    Lille, 59000

    Recruiting

  • Novartis Investigative Site

    Marseille, 13885

    Recruiting

  • Novartis Investigative Site

    Nice, 06000

    Recruiting

  • Novartis Investigative Site

    Nîmes, 30029

    Recruiting

  • Novartis Investigative Site

    Paris, 75940

    Recruiting

  • Novartis Investigative Site

    Poitiers, 86021

    Recruiting

  • Novartis Investigative Site

    Strasbourg, 67000

    Recruiting

  • Novartis Investigative Site

    Toulouse, 31059

    Recruiting

  • Novartis Investigative Site

    Tours, 37044

    Recruiting

Other trials in France

Spain11 sites, 11 recruiting

  • Novartis Investigative Site

    Barcelona, 08035

    Recruiting

  • Novartis Investigative Site

    Córdoba, 14004

    Recruiting

  • Novartis Investigative Site

    El Palmar, Murcia, 30120

    Recruiting

  • Novartis Investigative Site

    Madrid, 28009

    Recruiting

  • Novartis Investigative Site

    Madrid, 28034

    Recruiting

  • Novartis Investigative Site

    Madrid, 28040

    Recruiting

  • Novartis Investigative Site

    Madrid, 28222

    Recruiting

  • Novartis Investigative Site

    Málaga, 29010

    Recruiting

  • Novartis Investigative Site

    Seville, 41009

    Recruiting

  • Novartis Investigative Site

    Valencia, Valencia, 46017

    Recruiting

  • Novartis Investigative Site

    Valencia, 46026

    Recruiting

Other trials in Spain

Germany10 sites, 10 recruiting

  • Novartis Investigative Site

    Berlin, 13353

    Recruiting

  • Novartis Investigative Site

    Bochum, 44791

    Recruiting

  • Novartis Investigative Site

    Erbach im Odenwald, 64711

    Recruiting

  • Novartis Investigative Site

    Essen, 45147

    Recruiting

  • Novartis Investigative Site

    Greifswald, 17475

    Recruiting

  • Novartis Investigative Site

    Heidelberg, 69120

    Recruiting

  • Novartis Investigative Site

    Marburg, Hesse, 35043

    Recruiting

  • Novartis Investigative Site

    Münster, 48149

    Recruiting

  • Novartis Investigative Site

    Ulm, 89073

    Recruiting

  • Novartis Investigative Site

    Ulm, 89081

    Recruiting

Other trials in Germany

Italy7 sites, 7 recruiting

  • Novartis Investigative Site

    Bergamo, BG, 24127

    Recruiting

  • Novartis Investigative Site

    Foggia, FG, 71122

    Recruiting

  • Novartis Investigative Site

    Genova, GE, 16132

    Recruiting

  • Novartis Investigative Site

    Milan, MI, 20132

    Recruiting

  • Novartis Investigative Site

    Pavia, PV, 27100

    Recruiting

  • Novartis Investigative Site

    Roma, RM, 00133

    Recruiting

  • Novartis Investigative Site

    Roma, RM, 00168

    Recruiting

Other trials in Italy

Brazil6 sites, 6 recruiting

  • Novartis Investigative Site

    Fortaleza, Ceará, 60120-002

    Recruiting

  • Novartis Investigative Site

    Joinville, Santa Catarina, 89202-165

    Recruiting

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90430-001

    Recruiting

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90560-032

    Recruiting

  • Novartis Investigative Site

    São Paulo, São Paulo, 01244-030

    Recruiting

  • Novartis Investigative Site

    São Paulo, São Paulo, 04076-004

    Recruiting

Other trials in Brazil

Czechia6 sites, 5 recruiting

  • Novartis Investigative Site

    Brno, 602 00

    Active, not recruiting

  • Novartis Investigative Site

    Brno, 625 00

    Recruiting

  • Novartis Investigative Site

    Hradec Králové, 500 05

    Recruiting

  • Novartis Investigative Site

    Jihlava, 586 01

    Recruiting

  • Novartis Investigative Site

    Pardubice, 532 03

    Recruiting

  • Novartis Investigative Site

    Prague, 150 06

    Recruiting

Other trials in Czechia

Argentina4 sites, 4 recruiting

  • Novartis Investigative Site

    Buenos Aires, C1055AAF

    Recruiting

  • Novartis Investigative Site

    Caba, C1182

    Recruiting

  • Novartis Investigative Site

    Rosario, Santa Fe Province, 2000

    Recruiting

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000BZL

    Recruiting

Other trials in Argentina

Australia4 sites, 3 recruiting

  • Novartis Investigative Site

    Liverpool, 2170

    Withdrawn

  • Novartis Investigative Site

    Melbourne, Victoria, 3004

    Recruiting

  • Novartis Investigative Site

    Parkville, Victoria, 3050

    Recruiting

  • Novartis Investigative Site

    St Leonards, 2065

    Recruiting

Other trials in Australia

Canada4 sites, 4 recruiting

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 2B7

    Recruiting

  • Novartis Investigative Site

    Lévis, Quebec, G6W 0M5

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H4A 3T2

    Recruiting

  • Novartis Investigative Site

    Vancouver, British Columbia, V6T 2A1

    Recruiting

Other trials in Canada

United Kingdom4 sites, 4 recruiting

  • Novartis Investigative Site

    Leeds, LS1 3EX

    Recruiting

  • Novartis Investigative Site

    London, W6 8RF

    Recruiting

  • Novartis Investigative Site

    Sheffield, South Yorkshire, S10 2JF

    Recruiting

  • Novartis Investigative Site

    Swansea, SA6 6NL

    Recruiting

Other trials in United Kingdom

Greece3 sites, 3 recruiting

  • Novartis Investigative Site

    Chaïdári, 124 62

    Recruiting

  • Novartis Investigative Site

    Larissa, 411 10

    Recruiting

  • Novartis Investigative Site

    Thessaloniki, 532 46

    Recruiting

Other trials in Greece

Portugal3 sites, 3 recruiting

  • Novartis Investigative Site

    Braga, 4710-243

    Recruiting

  • Novartis Investigative Site

    Coimbra, 3004-561

    Recruiting

  • Novartis Investigative Site

    Lisbon, 1169-050

    Recruiting

Other trials in Portugal

Switzerland3 sites, 3 recruiting

  • Novartis Investigative Site

    Bern, 3010

    Recruiting

  • Novartis Investigative Site

    Lausanne, 1011

    Recruiting

  • Novartis Investigative Site

    Zurich, 8091

    Recruiting

Other trials in Switzerland

Belgium2 sites, 2 recruiting

  • Novartis Investigative Site

    Bruges, 8000

    Recruiting

  • Novartis Investigative Site

    Overpelt, 3900

    Recruiting

Other trials in Belgium

Denmark2 sites, 2 recruiting

  • Novartis Investigative Site

    Aarhus N, 8200

    Recruiting

  • Novartis Investigative Site

    Glostrup Municipality, 2600

    Recruiting

Other trials in Denmark

Mexico2 sites, 2 recruiting

  • Novartis Investigative Site

    Mexico City, Mexico City, 06700

    Recruiting

  • Novartis Investigative Site

    Mexico City, 14050

    Recruiting

Other trials in Mexico

Slovakia2 sites, 2 recruiting

  • Novartis Investigative Site

    Bratislava, Slovakia, 826 06

    Recruiting

  • Novartis Investigative Site

    Trnava, Slovakia, 917 02

    Recruiting

Other trials in Slovakia

South Africa2 sites, 2 recruiting

  • Novartis Investigative Site

    Cape Town, Western Cape, 7405

    Recruiting

  • Novartis Investigative Site

    Pretoria, 0041

    Recruiting

Other trials in South Africa

About this study

Official title: 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).

Read the 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.

Being tested
Remibrutinib oral treatment, Ocrelizumab
Keywords
MS, RMS, Remibrutinib, LOU064, Ocrelizumab, Age, MRI, T2 lesions, NEDA-3

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remibrutinib oral treatmentDrug

    Also called LOU064

    Remibrutinib tablet taken daily

  • OcrelizumabDrug

    Ocrelizumab 600mg infusion or 920mg injection

Study groups in NCT06846281
Study groupRoleWhat they receive
Remibrutinib CoreExperimentalRemibrutinib tablet taken orally
Receives: Drug: Remibrutinib oral treatment
Ocrelizumab CoreActive comparatorOcrelizumab at standard dose and route of administration (i.v. or s.c) per label
Receives: Drug: Ocrelizumab
Remibrutinib ExtensionExperimentalRemibrutinib tablet taken orally
Receives: Drug: Remibrutinib oral treatment
Remibrutinib Extension (Ocrelizumab in Core)ExperimentalRemibrutinib tablet taken orally
Receives: Drug: Remibrutinib oral treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized rate of new or enlarging T2 lesions_Core Part

    Number of new/enlarging T2 lesions per year on MRI at month 24 (relative to baseline)

    Measured: Baseline up to month 24

Secondary outcomes (5)

  1. Participants with no evidence of disease activity-3 (NEDA-3)_Core Part

    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

    Measured: Baseline up to month 24

  2. Number of adverse events (AEs) and serious adverse events (SAEs)_Core Part

    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

    Measured: Baseline up to month 24

  3. Annualized rate of new or enlarging T2 lesions_Extension Part

    Number of new/enlarging T2 lesions per year on MRI

    Measured: Month 24 up to month 48

  4. Participants with no evidence of disease activity-3 (NEDA-3)_Extension Part

    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

    Measured: Month 24 up to month 48

  5. Number of Adverse events and serious adverse events_Extension Part

    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

    Measured: Month 24 up to month 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2025
  2. Study start23 Jun 2025
  3. Primary completion25 Jul 2029 (estimated)
  4. Study completion25 Jun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06846281
Sponsor's protocol ID
CLOU064C12306
Other IDs
2023-509275-17, 2023
Status last verified
Oct 2026
First submitted
24 Feb 2025
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remibrutinib oral treatment and Ocrelizumab in people with Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 131 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in United States, France, Spain, Germany, Italy and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized rate of new or enlarging T2 lesions_Core Part (time frame: Baseline up to month 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06846281.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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