Relapsing Multiple Sclerosis (RMS)
Conditions
Keywords
Relapsing Multiple Sclerosis
Brief summary
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.
Detailed description
This is a Phase 3, open label, parallel-group, multicenter study in participants with relapsing multiple sclerosis
Interventions
BIOLOGICALOfatumumab approved dose
Approved dosage
BIOLOGICALOfatumumab new dose
New dosage
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ofatumumab plasma pharmacokinetics - area under the curve | Up to 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Ofatumumab plasma pharmacokinetics - minimum observed plasma concentration | Up to 12 weeks |
| Ofatumumab plasma pharmacokinetics - maximum observed plasma concentration | Up to 12 weeks |
| Incidence of Adverse events (AE) and Serious adverse events (SAE) | Up to 52 weeks |
| Proportion of participants with anti-drug antibodies | Up to 52 weeks |
| Participant B cell counts | Up to 52 weeks |
Countries
Puerto Rico, United States
Outcome results
None listed