Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab

Launched by NOVARTIS PHARMACEUTICALS · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to give a medication called ofatumumab to people with relapsing multiple sclerosis (RMS). The researchers want to see how this new dosage works in the body, how safe it is, and how well it can help manage the condition compared to the current approved dosage. If you or a family member is between 18 and 60 years old and has been diagnosed with RMS, you might be eligible to participate in this trial. However, certain health conditions or treatments may prevent participation, such as having a serious infection, specific neurological issues, or being pregnant or nursing.

Participants in this study will receive either the new or the standard dosage of ofatumumab, and they will be closely monitored for any side effects and how well the treatment works. Joining this trial is voluntary, and those who participate will help advance our understanding of this medication and potentially improve treatment options for others with RMS. If you're considering participation, it’s essential to discuss any questions or concerns with your healthcare provider to see if this trial is right for you.

Gender

ALL

Eligibility 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