A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation (SOSTOS)

Novartis

Status and phase: Enrolling; Phase 4

Conditions: Relapsing-Remitting Multiple Sclerosis

Treatments: Drug: Disease modifying treatment (DMT); Drug: Ofatumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05090371

COMB157GUS09

Details and patient eligibility

About

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.

Full description

This is a multicenter, prospective study of up to 150 relapsing-remitting MS participants/ The study is looking to see if patients who have not had a relapse in the past year would benefit from switching to ofatumumab.

After giving consent, participants will have a 1 week screening/qualification period. If they qualify to continue, they will start a a six month run-in period during which lab samples will be collected. Patients that are relapse-free during the run-in period will continue into next period of the study in which they will be randomized to either ofatumumab or continued therapy for the next 15 months. Every 3 out of 5 randomized participants will be selected to wear a digital study watch to collect physical activity, sleep, and vitals during this 15 month period. The study watch will be worn 24 hours a day, 7 days a week but can be removed during showers/bathing. At the end of the 15 month period, a study completion visit will be held.

The total study duration is 21 months plus 1 week for screening/qualification.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Ofatumumab

Experimental group

Description:

20 mg

Treatment:

Drug: Ofatumumab

DMT continued therapy

Active Comparator group

Description:

Participants randomized to the continued therapy arm will continue to take their disease modifying treatment (DMT) as prescribed commercially by their physician.

Treatment:

Drug: Disease modifying treatment (DMT)