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Could a simple blood test guide MS treatment? new study tests ofatumumab switch

NCT ID NCT05090371

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looks at whether people with relapsing-remitting MS who have not had a relapse in the past year but have high levels of a nerve damage marker (NfL) in their blood would benefit from switching to the drug ofatumumab. About 136 participants will either switch to ofatumumab or stay on their current therapy. The goal is to see if the switch leads to fewer relapses, less disability, and fewer brain lesions over 15 months.

What this could mean

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

Active substance
Ofatumumab
What this could lead to
If successful, this could show that switching to ofatumumab helps control MS activity better than staying on current therapy, especially for patients with elevated NfL levels.
What could go wrong
This is a Phase 4 study with only 136 participants, so results may not apply to all MS patients. The benefit may be small or not seen at all.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

136 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Apr 2027

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 50 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. * Age 18-45 years * Diagnosis of RRMS per McDonald Criteria (2017) * EDSS 0-5.5 (Inclusive) * Able to obtain MRI and attend study visits at sites * Willing to use wearable device as specified in the protocol * Able to provide blood sample * On a current DMT with approved label use for treatment of RRMS at least 6 months prior to Screening * No relapse reported within 6 months prior to Screening * Patients may enroll in the trial if they have subclinical disease activity as measured by MRI prior to enrollment. An absence of MRI activity is not exclusionary. Exclusion Criteria: * Primary progressive or secondary progressive phenotype * Diseases other than multiple sclerosis responsible for the clinical or MRI presentation * Use of experimental or investigational drugs for MS within 2 years from Screening * Known sensitivity to gadolinium * Central Nervous System (CNS) anomalies that are better accounted for by another disease process * Known active malignancies * Active chronic disease (or stable but treated with immune therapy) of the immune system other than MS * Active infections including systemic bacterial, viral (including COVID-19) or fungal infections, known to have AIDS or tested positive for HIV antibodies * Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML * IgG or IgM levels below lower limit of normal (LLN) at Screening

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Conditions

The condition(s) this trial relates to.

multiple sclerosis Recurrence relapsing-remitting multiple sclerosis

As listed by the trial registrant

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

Relapsing-remitting multiple sclerosis

Contacts and locations

Locations

  • Alabama Neurology Associates PC

    Birmingham, Alabama, 35209, United States

  • Arizona Neuroscience Research LLC

    Phoenix, Arizona, 85032, United States

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311, United States

  • Clinical Trial Network

    Houston, Texas, 77074, United States

  • Covenant Medical Group

    Lubbock, Texas, 79410, United States

  • Emerald Coast Neurology

    Pensacola, Florida, 32514, United States

  • Evergreen Health Multiple Sclerosis Center

    Kirkland, Washington, 98034, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2689, United States

  • Homestead Assoc In Research Inc

    Homestead, Florida, 33033, United States

  • International Neurorehab Institute

    Lutherville, Maryland, 21093, United States

  • Jersey Shore University Medical Ctr

    Neptune City, New Jersey, 07753, United States

  • Kootenai Health

    Coeur d'Alene, Idaho, 83815, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Healthcare

    Owosso, Michigan, 48867, United States

  • Neuro Medial Clinic of Central Louisiana

    Alexandria, Louisiana, 71301, United States

  • Neuro Mind Clinical Trials Ltd Co

    Katy, Texas, 77449, United States

  • Neurology Associates PA

    Maitland, Florida, 32751, United States

  • Neurology of Central FL Res Ctr

    Altamonte Springs, Florida, 32714, United States

  • North Central Neurology Associates PC

    Cullman, Alabama, 35058, United States

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 2B7, Canada

  • Novartis Investigative Site

    Burnaby, British Columbia, V5G 2X6, Canada

  • Novartis Investigative Site

    Vancouver, British Columbia, V6T 2A1, Canada

  • Novartis Investigative Site

    Granby, Quebec, J2G 1T7, Canada

  • Novartis Investigative Site

    Lévis, Quebec, G6W 0M5, Canada

  • Novartis Investigative Site

    Saskatoon, Saskatchewan, S7K 0M7, Canada

  • Orlando Health Clinical Trials

    Orlando, Florida, 32806, United States

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485, United States

  • Piedmont HealthCare

    Charlotte, North Carolina, 28210, United States

  • Radiant Research Chandler

    Chandler, Arizona, 85224, United States

  • Reliant Medical Group

    Worcester, Massachusetts, 01608, United States

  • S And D Clinical Research

    Cape Coral, Florida, 33904, United States

  • SUNY Upstate Medical Center

    Syracuse, New York, 13210, United States

  • Sentara Neuroscience Institute

    Virginia Beach, Virginia, 23456, United States

  • Sibyl Wray MD Neurology PC

    Knoxville, Tennessee, 37922, United States

  • St Barnabas Medical Center

    Livingston, New Jersey, 07039, United States

  • Swedish Medical Center

    Seattle, Washington, 98122-4379, United States

  • Tranquil Clinical Research

    Webster, Texas, 77598, United States

  • University Of NC At Chapel Hill

    Chapel Hill, North Carolina, 27599 9500, United States

  • University Of South Florida

    Tampa, Florida, 33612, United States

  • University of California at Los Angeles

    Torrance, California, 90509-2004, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505, United States

  • Velocity Clinical Research

    Raleigh, North Carolina, 27607, United States

  • West Texas Cancer Center

    Odessa, Texas, 79761, United States

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