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Switching to Ofatumumab for Patients with Relapsing-Remitting Multiple Sclerosis

A Randomized, Open Label, Multi-center, Active-comparator Study to Assess Efficacy, Safety & Tolerability of Ofatumumab 20mg sc Monthly Versus Continued Current Therapy in Relapsing-remitting Multiple Sclerosis After Elevation of Serum Neurofilament Light Levels (SOSTOS)

Phase 4 Interventional Novartis · NCT05090371

This study is testing if switching to a new treatment called ofatumumab helps people with relapsing-remitting multiple sclerosis who haven't had a relapse in the past year feel better compared to sticking with their current medication.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years to 50 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsofatumumab
Locations41 sites (Birmingham, Alabama and 40 other locations)
Trial IDNCT05090371 on ClinicalTrials.gov

What this trial studies

This multicenter study evaluates whether patients with relapsing-remitting multiple sclerosis (RRMS) who have not experienced a relapse in the past year would benefit from switching to ofatumumab compared to continuing their current therapy. The study will also investigate if elevated serum neurofilament light (NfL) levels can predict the benefits of this switch. Participants will undergo a screening period followed by a run-in phase, and those who remain relapse-free will be randomized to receive either ofatumumab or their current treatment for 15 months. Additionally, some participants will wear a digital study watch to monitor physical activity, sleep, and vital signs throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-45 with a diagnosis of relapsing-remitting multiple sclerosis who have not had a relapse in the past year.

Not a fit: Patients with primary or secondary progressive multiple sclerosis or those with other diseases affecting their clinical presentation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective treatment strategies for patients with RRMS, potentially improving their long-term outcomes.

How similar studies have performed: While this approach is novel in evaluating the switch to ofatumumab based on NfL levels, similar studies have shown promise in optimizing treatment for MS patients.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsing-Remitting Multiple SclerosisOfatumumabMultiple SclerosisadultOMB157RRMSMSsecondary progressive MS
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.