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New dosing regimen of Ofatumumab for relapsing multiple sclerosis

An Open-label, Randomized, Parallel Group, Non-inferiority Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab, Followed by Extended Treatment in Participants With Relapsing Multiple Sclerosis

Phase 3 Interventional Novartis · NCT06869785

This study is testing a new dosing schedule of Ofatumumab to see if it works better and is safer for people with relapsing multiple sclerosis compared to the current approved dose.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsocrelizumab, rituximab, ofatumumab, ublituximab, inebilizumab
Locations25 sites (Fullerton, California and 24 other locations)
Trial IDNCT06869785 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacokinetics, pharmacodynamics, safety, and tolerability of a new maintenance dosing regimen of Ofatumumab compared to the approved dosage in participants with relapsing multiple sclerosis. It is a Phase 3, open-label, parallel-group, multicenter study designed to gather comprehensive data on the effects of the new dosing regimen. Participants will receive either the approved dose or the new dose of Ofatumumab, and their responses will be monitored throughout the study.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 60 with a diagnosis of relapsing forms of multiple sclerosis.

Not a fit: Patients with a history of progressive multifocal leukoencephalopathy or those at risk of hepatitis reactivation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with relapsing multiple sclerosis.

How similar studies have performed: Other studies have shown success with similar dosing regimens of Ofatumumab, indicating potential for positive outcomes.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Fullerton, California and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsing Multiple Sclerosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.