Neuroscience

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SOSTOS: A randomized, open label, multi-center, active-comparator study to assess the efficacy, safety and tolerability of ofatumumab 20mg sc monthly versus continued current therapy in relapsing-remitting multiple sclerosis after elevation of serum neurofilament light levels (SOSTOS)
Description
This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.
Eligibility Criteria

Signed informed consent must be obtained prior to participation in the study.
Age 18-45 years
Diagnosis of RRMS per McDonald Criteria (2017)
EDSS 0-5.5 (Inclusive)
Able to obtain MRI and attend study visits at sites
Willing to use wearable device as specified in the protocol
Able to provide blood sample
On a current DMT with approved label use for treatment of RRMS at least 6 months prior to Screening
No relapse reported within 6 months prior to Screening
Patients may enroll in the trial if they have subclinical disease activity as measured by MRI prior to enrollment. An absence of MRI activity is not exclusionary.

Exclusion Criteria:

Primary progressive or secondary progressive phenotype
Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
Use of experimental or investigational drugs for MS within 2 years from Screening
Known sensitivity to gadolinium
Central Nervous System (CNS) anomalies that are better accounted for by another disease process
Known active malignancies
Active chronic disease (or stable but treated with immune therapy) of the immune system other than MS
Active infections including systemic bacterial, viral (including COVID-19) or fungal infections, known to have AIDS or tested positive for HIV antibodies
Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
IgG or IgM levels below lower limit of normal (LLN) at Screening