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

Novartis

Status and phase: Enrolling; Phase 3

Conditions: Relapsing Multiple Sclerosis (RMS)

Treatments: Biological: Ofatumumab approved dose; Biological: Ofatumumab new dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT06869785

COMB157Q12301

Details and patient eligibility

About

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.

Full description

This is a Phase 3, open label, parallel-group, multicenter study in participants with relapsing multiple sclerosis

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Ofatumumab dose 1

Active Comparator group

Description:

Approved dosage

Treatment:

Biological: Ofatumumab new dose

Biological: Ofatumumab approved dose

Ofatumumab dose 2

Experimental group

Description:

New dosage

Treatment:

Biological: Ofatumumab new dose