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

Running, not enrolling · Phase 3

Conditions studied: Relapsing Multiple Sclerosis (RMS)

In brief

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.

Key facts

Study ID

NCT06869785

Run by

Novartis Pharmaceuticals

People needed

196

Starts

2025-03-13

Expected to finish

2030-03-23

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 it is running

• Xenoscience Inc — Phoenix, Arizona, United States
• Ctr for Neurology and Spine — Phoenix, Arizona, United States
• Phoenix Neurological Associates — Phoenix, Arizona, United States
• The Research and Education Inst. of Alta Bates Summit Med. Grp — Berkeley, California, United States
• Fullerton Neuro and Headache Ctr — Fullerton, California, United States
• University of California Irvine — Irvine, California, United States
• CenExcel Clinical Research — Los Alamitos, California, United States
• Velocity Clinical Trials — Los Angeles, California, United States
• Regina Berkovich MD PhD Inc — West Hollywood, California, United States
• CU Anschutz Med Campus — Aurora, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Neurology of Central FL Res Ctr — Altamonte Springs, Florida, United States
• Neurology Offices Of South Florida — Boca Raton, Florida, United States
• First Choice Neurology — Boca Raton, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Memorial Healthcare System — Hollywood, Florida, United States
• Neurology Associates PA — Maitland, Florida, United States
• UM Department Of Neurology — Miami, Florida, United States
• Elite Clinical Research — Miami, Florida, United States
• Reliant Medical Research — Miami, Florida, United States
• Aqualane Clinical Research — Naples, Florida, United States
• AdventHealth — Orlando, Florida, United States
• Orlando Health Clinical Trials — Orlando, Florida, United States
• Neurology Associates of Ormond Beach — Ormond Beach, Florida, United States
• Alabama Neurology Associates PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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