Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New M

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

Running, not recruitingPhase 3Relapsing and progressiveNCT06869785

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Ofatumumab new dose

Compared with

  • Ofatumumab approved dose

What it measured

Main measures

  • Ofatumumab plasma pharmacokinetics - area under the curve

    Up to 12 weeks

    How the body handles the medicine

Other measures (5)

  • Ofatumumab plasma pharmacokinetics - minimum observed plasma concentration

    Up to 12 weeks

    How the body handles the medicine

  • Ofatumumab plasma pharmacokinetics - maximum observed plasma concentration

    Up to 12 weeks

    How the body handles the medicine

  • Incidence of Adverse events (AE) and Serious adverse events (SAE)

    Up to 52 weeks

    Safety

  • Proportion of participants with anti-drug antibodies

    Up to 52 weeks

    Immune response

  • Participant B cell counts

    Up to 52 weeks

    Immune response

Who could take part

Relapsing and progressive · 18 to 100

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis.

Papers

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    History

      1. Started

        Mar 2025

      2. Main results due

        Jan 2026

      3. Finished

        Mar 2030

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