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Could a daily pill replace infusions for MS? new trial aims to find out

NCT ID NCT06846281

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times

Summary

This phase 3 trial is testing whether a daily pill called remibrutinib works as well as the standard infusion or injection ocrelizumab for people with relapsing multiple sclerosis. About 360 adults aged 40–70 who are stable on ocrelizumab will either switch to remibrutinib or stay on ocrelizumab. The study will track brain lesions, relapses, and disability progression over two years to see if the switch is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Remibrutinib (daily tablet)
What this could lead to
If successful, this could offer people with relapsing MS a convenient daily pill option instead of regular infusions or injections, while still controlling the disease.
What could go wrong
This is a non-inferiority study, so remibrutinib may not be better than ocrelizumab—just as good or possibly worse. It is also a switch study, so results may not apply to people starting treatment for the first time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsing multiple sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    126 sites in 19 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advent Health Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Aqualane Clinical Research

    RECRUITING

    Naples, Florida, 34105, United States

  • Austin Regional Clinic

    RECRUITING

    Austin, Texas, 78731, United States

  • Center for Neurological Disorders G

    RECRUITING

    Greenfield, Wisconsin, 53228-1321, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Las Vegas, Nevada, 89106, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Elite Clinical Research

    RECRUITING

    Miami, Florida, 33144, United States

  • Holy Name Medical Center

    RECRUITING

    Teaneck, New Jersey, 07666, United States

  • John Peter Smith Hospital

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Lahey Hospital and Medical Center

    RECRUITING

    Burlington, Massachusetts, 01805, United States

  • MedStar Montgomery Medical Center

    RECRUITING

    Olney, Maryland, 20832, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medstar Washington Hospital Center

    RECRUITING

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

  • Memorial HC Ins for Neuroscience

    RECRUITING

    Owosso, Michigan, 48867, United States

  • Memorial Healthcare System

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Michigan Institute of Neurological

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Neurology Associates PA

    RECRUITING

    Maitland, Florida, 32751, United States

    Contact Email: •••••@•••••

  • Neurology Center of New England PC

    RECRUITING

    Foxborough, Massachusetts, 02035, United States

  • Neurology of Central FL Res Ctr

    RECRUITING

    Altamonte Springs, Florida, 32714, United States

    Contact Email: •••••@•••••

  • Novartis Investigative Site

    RECRUITING

    Rosario, Santa Fe Province, 2000, Argentina

  • Novartis Investigative Site

    RECRUITING

    Rosario, Santa Fe Province, S2000BZL, Argentina

  • Novartis Investigative Site

    RECRUITING

    Buenos Aires, C1055AAF, Argentina

  • Novartis Investigative Site

    RECRUITING

    Caba, C1182, Argentina

  • Novartis Investigative Site

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    RECRUITING

    Parkville, Victoria, 3050, Australia

  • Novartis Investigative Site

    WITHDRAWN

    Liverpool, 2170, Australia

  • Novartis Investigative Site

    RECRUITING

    St Leonards, 2065, Australia

  • Novartis Investigative Site

    RECRUITING

    Bruges, 8000, Belgium

  • Novartis Investigative Site

    RECRUITING

    Overpelt, 3900, Belgium

  • Novartis Investigative Site

    RECRUITING

    Fortaleza, Ceará, 60120-002, Brazil

  • Novartis Investigative Site

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

  • Novartis Investigative Site

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90560-032, Brazil

  • Novartis Investigative Site

    RECRUITING

    Joinville, Santa Catarina, 89202-165, Brazil

  • Novartis Investigative Site

    RECRUITING

    São Paulo, São Paulo, 01244-030, Brazil

  • Novartis Investigative Site

    RECRUITING

    São Paulo, São Paulo, 04076-004, Brazil

  • Novartis Investigative Site

    RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

  • Novartis Investigative Site

    RECRUITING

    Vancouver, British Columbia, V6T 2A1, Canada

  • Novartis Investigative Site

    RECRUITING

    Lévis, Quebec, G6W 0M5, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H4A 3T2, Canada

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Brno, 602 00, Czechia

  • Novartis Investigative Site

    RECRUITING

    Brno, 625 00, Czechia

  • Novartis Investigative Site

    RECRUITING

    Hradec Králové, 500 05, Czechia

  • Novartis Investigative Site

    RECRUITING

    Jihlava, 586 01, Czechia

  • Novartis Investigative Site

    RECRUITING

    Pardubice, 532 03, Czechia

  • Novartis Investigative Site

    RECRUITING

    Prague, 150 06, Czechia

  • Novartis Investigative Site

    RECRUITING

    Aarhus N, 8200, Denmark

  • Novartis Investigative Site

    RECRUITING

    Glostrup Municipality, 2600, Denmark

  • Novartis Investigative Site

    RECRUITING

    Bordeaux, 33076, France

  • Novartis Investigative Site

    RECRUITING

    Clermont-Ferrand, 63003, France

  • Novartis Investigative Site

    RECRUITING

    Lille, 59000, France

  • Novartis Investigative Site

    RECRUITING

    Marseille, 13885, France

  • Novartis Investigative Site

    RECRUITING

    Nice, 06000, France

  • Novartis Investigative Site

    RECRUITING

    Nîmes, 30029, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75940, France

  • Novartis Investigative Site

    RECRUITING

    Poitiers, 86021, France

  • Novartis Investigative Site

    RECRUITING

    Strasbourg, 67000, France

  • Novartis Investigative Site

    RECRUITING

    Toulouse, 31059, France

  • Novartis Investigative Site

    RECRUITING

    Tours, 37044, France

  • Novartis Investigative Site

    RECRUITING

    Berlin, 13353, Germany

  • Novartis Investigative Site

    RECRUITING

    Bochum, 44791, Germany

  • Novartis Investigative Site

    RECRUITING

    Erbach im Odenwald, 64711, Germany

  • Novartis Investigative Site

    RECRUITING

    Essen, 45147, Germany

  • Novartis Investigative Site

    RECRUITING

    Greifswald, 17475, Germany

  • Novartis Investigative Site

    RECRUITING

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    RECRUITING

    Münster, 48149, Germany

  • Novartis Investigative Site

    RECRUITING

    Ulm, 89073, Germany

  • Novartis Investigative Site

    RECRUITING

    Ulm, 89081, Germany

  • Novartis Investigative Site

    RECRUITING

    Chaïdári, 124 62, Greece

  • Novartis Investigative Site

    RECRUITING

    Larissa, 411 10, Greece

  • Novartis Investigative Site

    RECRUITING

    Thessaloniki, 53246, Greece

  • Novartis Investigative Site

    RECRUITING

    Bergamo, BG, 24127, Italy

  • Novartis Investigative Site

    RECRUITING

    Foggia, FG, 71122, Italy

  • Novartis Investigative Site

    RECRUITING

    Genova, GE, 16132, Italy

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20132, Italy

  • Novartis Investigative Site

    RECRUITING

    Pavia, PV, 27100, Italy

  • Novartis Investigative Site

    RECRUITING

    Roma, RM, 00133, Italy

  • Novartis Investigative Site

    RECRUITING

    Roma, RM, 00168, Italy

  • Novartis Investigative Site

    RECRUITING

    Mexico City, Mexico City, 06700, Mexico

  • Novartis Investigative Site

    RECRUITING

    Mexico City, 14050, Mexico

  • Novartis Investigative Site

    RECRUITING

    Braga, 4710243, Portugal

  • Novartis Investigative Site

    RECRUITING

    Coimbra, 3004-561, Portugal

  • Novartis Investigative Site

    RECRUITING

    Lisbon, 1169-050, Portugal

  • Novartis Investigative Site

    RECRUITING

    Bratislava, Slovakia, 826 06, Slovakia

  • Novartis Investigative Site

    RECRUITING

    Trnava, Slovakia, 917 02, Slovakia

  • Novartis Investigative Site

    RECRUITING

    Cape Town, Western Cape, 7405, South Africa

  • Novartis Investigative Site

    RECRUITING

    Pretoria, 0041, South Africa

  • Novartis Investigative Site

    RECRUITING

    El Palmar, Murcia, 30120, Spain

  • Novartis Investigative Site

    RECRUITING

    Valencia, Valencia, 46017, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28009, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28034, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28040, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28222, Spain

  • Novartis Investigative Site

    RECRUITING

    Málaga, 29010, Spain

  • Novartis Investigative Site

    RECRUITING

    Seville, 41009, Spain

  • Novartis Investigative Site

    RECRUITING

    Valencia, 46026, Spain

  • Novartis Investigative Site

    RECRUITING

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Lausanne, 1011, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Zurich, 8091, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Sheffield, South Yorkshire, S10 2JF, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Leeds, LS1 3EX, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, W6 8RF, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Swansea, SA6 6NL, United Kingdom

  • Ohio Health Research Institute

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Orlando Health Clinical Trials

    RECRUITING

    Orlando, Florida, 32806, United States

  • Perseverance Research Center

    RECRUITING

    Scottsdale, Arizona, 85253, United States

  • Premier Health

    RECRUITING

    Centerville, Ohio, 45459, United States

  • Premier Neurology

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Providence Neurological Services West

    RECRUITING

    Portland, Oregon, 97225, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60607, United States

  • SUNY Buffalo The Jacobs Neuro Inst

    RECRUITING

    Buffalo, New York, 14203, United States

  • Sanford Health

    RECRUITING

    Fargo, North Dakota, 58122, United States

  • Saturn Research Solutions LLC

    RECRUITING

    Plano, Texas, 75024, United States

  • Sibyl Wray MD Neurology PC

    RECRUITING

    Knoxville, Tennessee, 37922, United States

  • Tallahassee Neurological Clinic

    RECRUITING

    Tallahassee, Florida, 32308, United States

  • Tufts Medical Center

    WITHDRAWN

    Boston, Massachusetts, 02111, United States

  • Univ of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Univ of Texas Southwest Med Center

    RECRUITING

    Dallas, Texas, 75390-9034, United States

  • University Of South Florida

    RECRUITING

    Tampa, Florida, 33612, United States

  • University of California Irvine

    RECRUITING

    Irvine, California, 92697, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Kansas Hospital

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of New Mexico

    RECRUITING

    Albuquerque, New Mexico, 87131-0001, United States

  • Velocity Clinical Research

    RECRUITING

    Raleigh, North Carolina, 27607, United States

  • Vero Beach Neurology

    RECRUITING

    Vero Beach, Florida, 32960, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298-0111, United States

  • WA Uni School Of Med

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.