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Could a simpler dosing schedule for an MS drug work just as well?

NCT ID NCT06869785

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 11, 2026 · Updated 2 times

Summary

This study tests a new maintenance dosing schedule for ofatumumab, a drug used to control relapsing multiple sclerosis (MS). Researchers want to see if the new schedule is as safe and effective as the current approved dose. About 196 adults with relapsing MS will take part, and the study will measure drug levels in the blood and monitor side effects.

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

196 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Mar 2030

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

18 to 100 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.

Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Male or female study participants aged 18 to 60 years (inclusive) at screening. * Diagnosis of multiple sclerosis (MS) according to the 2017 Revised McDonald criteria (Thompson et al 2018). Relapsing forms of MS: relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS). Exclusion Criteria: * Participants suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator or emergence of any clinically significant condition/disease (e.g. active systemic bacterial, viral or fungal infections) during screening prior to Day 1 which might result in safety risk for participants. * Participants with history of confirmed progressive multifocal leukoencephalopathy (PML) or neurological symptoms consistent with PML. * Participants at risk of developing or having reactivation of hepatitis * Emergence of active chronic disease (or stable but treated with immune therapy) prior to Day 1 of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency). * Pregnant or nursing (lactating) women * History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system (except for basal cell carcinoma, or squamous cell carcinomas of the skin that have been treated with no evidence of recurrence in the past 3 months). * Participants taking prohibited therapies, including B cell targeted therapies (e.g. such as ocrelizumab, rituximab, ofatumumab, ublituximab, and inebilizumab) Other protocol-defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

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

Relapsing multiple sclerosis (RMS)

Contacts and locations

Locations

  • Advent Neurology Clinic

    Roeland Park, Kansas, 66205, United States

  • AdventHealth

    Orlando, Florida, 32804, United States

  • Alabama Neurology Associates PC

    Birmingham, Alabama, 35209, United States

  • Aqualane Clinical Research

    Naples, Florida, 34105, United States

  • Atlanta NeuroScience Institute

    Atlanta, Georgia, 30327, United States

  • Axiom Brain Health

    Tampa, Florida, 33609, United States

  • CU Anschutz Med Campus

    Aurora, Colorado, 80045, United States

  • Caribbean Center for Clinical Research Inc

    Guaynabo, 00968, Puerto Rico

  • Carum Research

    Dallas, Texas, 75231, United States

  • CenExcel Clinical Research

    Los Alamitos, California, 90720, United States

  • Cleveland Clinic Foundation

    Las Vegas, Nevada, 89106, United States

  • Conquest Research

    Vienna, Virginia, 22182, United States

  • Ctr for Neurology and Spine

    Phoenix, Arizona, 85018, United States

  • Dayton Center for Neurological Disorders

    Centerville, Ohio, 45459, United States

  • Delricht Research

    New Orleans, Louisiana, 70115, United States

  • Elite Clinical Research

    Miami, Florida, 33144, United States

  • First Choice Neurology

    Boca Raton, Florida, 33486, United States

  • Fullerton Neuro and Headache Ctr

    Fullerton, California, 92835, United States

  • Hackensack University Medical Ctr

    Hackensack, New Jersey, 07601, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2689, United States

  • International Neurorehab Institute

    Lutherville, Maryland, 21093, United States

  • Josephson Wallack Munshower Neurology PC

    Indianapolis, Indiana, 46256, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medstar Washington Hospital Center

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

  • Memorial Healthcare System

    Hollywood, Florida, 33021, United States

  • Mid Atlantic Epilepsy and Sleep Ctr

    Bethesda, Maryland, 20817-1807, United States

  • MultiCare Research Institute for Research and Innovation

    Tacome, Washington, 98405, United States

  • Neuro Medial Clinic of Central Louisiana

    Alexandria, Louisiana, 71301, United States

  • Neurology Associates PA

    Maitland, Florida, 32751, United States

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174, United States

  • Neurology Clinic PC

    Cordova, Tennessee, 38018, United States

  • Neurology Offices Of South Florida

    Boca Raton, Florida, 33428, United States

  • Neurology of Central FL Res Ctr

    Altamonte Springs, Florida, 32714, United States

  • Neurostudies Inc

    Port Charlotte, Florida, 33952, United States

  • OSU Wexner Medical Center

    Columbus, Ohio, 43221, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Orlando Health Clinical Trials

    Orlando, Florida, 32806, United States

  • Phoenix Neurological Associates

    Phoenix, Arizona, 85018, United States

  • Premiere Research Institute

    West Palm Beach, Florida, 33407, United States

  • Puerto Rico Multiple Sclerosis Ctr

    Caguas, 00725, Puerto Rico

  • Regina Berkovich MD PhD Inc

    West Hollywood, California, 90048, United States

  • Rochester Cent For Behavioral

    Rochester Hills, Michigan, 48307, United States

  • Saturn Research Solutions LLC

    Plano, Texas, 75024, United States

  • Sentara Neuroscience Institute

    Virginia Beach, Virginia, 23456, United States

  • Sibyl Wray MD Neurology PC

    Knoxville, Tennessee, 37922, United States

  • South Shore Neurologic Associates

    Patchogue, New York, 11772, United States

  • Swedish Neuroscience Institute

    Seattle, Washington, 98122, United States

  • Tallahassee Neurological Clinic

    Tallahassee, Florida, 32308, United States

  • The Research and Education Inst of Alta Bates Summit Med Grp

    Berkeley, California, 94705, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107-5098, United States

  • True North Neurology

    Port Jefferson, New York, 11776, United States

  • UM Department Of Neurology

    Miami, Florida, 33136, United States

  • Univ of Kansas Hosp and Med Ctr

    Kansas City, Kansas, 66160, United States

  • University Of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University Of South Florida

    Tampa, Florida, 33612, United States

  • University of California Irvine

    Irvine, California, 92697, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • University of Tennessee Medical Ctr

    Knoxville, Tennessee, 37920, United States

  • Velocity Clinical Research

    Raleigh, North Carolina, 27607, United States

  • Velocity Clinical Trials

    Los Angeles, California, 90057, United States

  • Vero Beach Neurology

    Vero Beach, Florida, 32960, United States

  • WA Uni School Of Med

    St Louis, Missouri, 63110, United States

  • Xenoscience Inc

    Phoenix, Arizona, 85004, United States

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