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Can a monthly injection stop MS in its tracks? new study aims to find out

NCT ID NCT05084638

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a monthly injection of ofatumumab in 180 people with very early relapsing-remitting multiple sclerosis (MS). The goal was to see if the drug could stop all signs of disease activity—like relapses, disability worsening, and new brain lesions—over 18 months. Researchers also compared these patients to healthy volunteers to see if treatment could make their health measures similar to people without MS.

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

180 people

The number who actually took part.

Started

Jan 2022

Finished

Feb 2026

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 35 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Participants eligible for inclusion in this study must meet all of the following criteria: 1. Signed informed consent must be obtained prior to participation in the study 2. Age 18-35 years Patients in the healthy control arm eligible for inclusion must fulfill the following criteria: 3. Able to obtain MRI (HC with abnormal MRI at Screening will be excluded) and use wearable device 4. Able to provide blood sample (no CSF will be collected in HC) Patients in the ofatumumab-treated arm eligible for inclusion must fulfill the following criteria: 5. Diagnosis of RRMS per McDonald Criteria (2010/2017) 6. Within 6 months of diagnosis of clinically definite MS (CDMS) 7. EDSS 0-3.0 (Inclusive) 8. Treatment-naïve to MS DMT 9. Able to obtain MRI and attend study visits at sites 10. Able to use wearable device 11. Able to provide blood sample (and CSF for sub-group n=15) Key Exclusion Criteria: Participants in the healthy control arm meeting any of the following criteria are not eligible for inclusion in this study: 1. Confounding medical condition as determined by the investigator RRMS patients fulfilling any of the following exclusion criteria are not eligible for inclusion in this study: 2. Diseases other than multiple sclerosis responsible for the clinical or MRI presentation 3. Patients with neuromyelitis optica, Radiologic/ Clinically Isolated Syndrome, Secondary Progressive or Primary Progressive MS diagnosis 4. Use of experimental or investigational drugs for MS 5. Previous use of Disease Modifying Therapy (DMT) or chemotherapeutic medications for MS 6. Relapse between screening and Baseline visits 7. Known sensitivity to gadolinium; patients with chronic, severe kidney disease 8. Known history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes 9. CNS anomalies that are better accounted for by another disease process or MRI anomalies causing clinically apparent impairments 10. Known active malignancies 11. Pregnant or nursing (lactating) women 12. Females of childbearing potential (all women physiologically capable of becoming pregnant) should use effective contraception while receiving ofatumumab and for 6 months after the last treatment of ofatumumab 13. Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS or with immunodeficiency syndrome 14. Patients with active infections including systemic bacterial, viral (including SARS-CoV-2/COVID-19) or fungal infections, or known to have AIDS or to test positive for HIV antibody at Screening 15. Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML 16. Patients with IgG or IgM levels below LLN at Screening 17. Patients that have received any live or live-attenuated vaccines within 4 weeks prior to first dose of study drug administration 18. Patients at risk of developing or having reactivation of hepatitis

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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.

Relapse remitting multiple sclerosis

Contacts and locations

Locations

  • Arizona Neuroscience Research LLC

    Phoenix, Arizona, 85032, United States

  • Barrow Neurological Clinics at St Josephs Hospital and MC

    Phoenix, Arizona, 85013, United States

  • Caribbean Center for Clinical Research, Inc

    Guaynabo, 00968, Puerto Rico

  • Emerald Coast Neurology

    Pensacola, Florida, 32514, United States

  • Evergreen Health Multiple Sclerosis Center

    Kirkland, Washington, 98034, United States

  • First Choice Neurology

    Boca Raton, Florida, 33486, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2689, United States

  • Keck School of Medicine

    Los Angeles, California, 90033, United States

  • Lonestar Neurology of San Antonio

    San Antonio, Texas, 78258, United States

  • Lundquist Inst BioMed at Harbor

    Torrance, California, 90509-2910, United States

  • MD First Research

    Chandler, Arizona, 85226, United States

  • MedStar Health

    Washington D.C., District of Columbia, 20007, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • MultiCare Neuroscience Center of Washington

    Tacoma, Washington, 98405, United States

  • Multiple Sclerosis Center of Excellence of OMRF

    Oklahoma City, Oklahoma, 73104, United States

  • Neurology Associates PA

    Maitland, Florida, 32751, United States

  • Neurology Diagnostics Inc

    Dayton, Ohio, 45408, United States

  • Neurology of Central FL Res Ctr

    Altamonte Springs, Florida, 32714, United States

  • Neuroscience Institute at Hackensack

    Hackensack, New Jersey, 07601, United States

  • Ochsner Cancer Institute

    New Orleans, Louisiana, 70121, United States

  • Orlando Health Clinical Trials

    Orlando, Florida, 32806, United States

  • Regina Berkovich MD PhD Inc

    West Hollywood, California, 90048, United States

  • Renown Institute for Neurosciences

    Reno, Nevada, 89521, United States

  • Shepherd Center

    Atlanta, Georgia, 30309, United States

  • Sibyl Wray MD Neurology PC

    Knoxville, Tennessee, 37922, United States

  • Tallahassee Neurological Clinic

    Tallahassee, Florida, 32308, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107-5098, United States

  • UC Health Neuroscience Ctr

    Aurora, Colorado, 80045, United States

  • UT Health Science Center

    Houston, Texas, 77030, United States

  • Univ of Texas Southwest Med Center

    Dallas, Texas, 75390-9034, United States

  • University Of South Florida

    Tampa, Florida, 33612, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001, United States

  • Velocity Clinical Research

    Raleigh, North Carolina, 27607, United States

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

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