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NCT Number: NCT05090371

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ofatumumab

Drug

3 loading doses followed by administration every 4 weeks as per label

Disease modifying treatment (DMT)

Drug

Other DMT with approved label use for treatment which participants were on at least 6 months prior to Screening

Primary outcomes

  1. Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3)

    Time frame: Months 3 to 15

    A participant is considered as achieved NEDA-3 if the participant has not had a clinical relapse (recurrence of a disease activity after a recovery), has not had an increase in disability and has no new radiological MRI activity (no new occurrences of contrast-enhancing lesions) during study Months 3 to 15.

Secondary outcomes

  1. Percentage of participants with a single baseline NfL≥10pg/ml and NfL<10pg/ml achieving NEDA-3 (No Evidence of Disease Activity-3)

    Time frame: Months 3 to15

    Participants with a single baseline NfL≥10 pg/ml and NfL<10pg/ml will be considered as achieved NEDA-3 if the participant has not had a clinical relapse (recurrence of a disease activity after a recovery), has not had an increase in disability and has no new radiological MRI activity (no new occurrences of contrast-enhancing lesions)

  2. Annualized relapse rate in Months 3 to 15

    Time frame: Months 3 to 15

    Relapses are recurrences of a disease activity after a recovery. A confirmed MS relapse is one accompanied by a clinically relevant change in the EDSS performed by the EDSS Rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores (FSs) or 2 points on one FS, excluding changes involving bowel/bladder or cerebral FS compared to the previous available rating (the last EDSS rating that did not occur during a relapse). Confirmation of MS relapse based on these definitions will be done centrally.

  3. Percentage of participants without a worsening of their disability

    Time frame: Months 3 to 15

    No increase or worsening of disability

  4. Percentage of participants with NEDA (No Evidence of Disease Activity) - Clinical

    Time frame: Months 3 to 15

    A participant is considered as achieved NEDA-clinical is no clinical relapse or disease progression (by EDSS) has occurred.

  5. Percentage of participants with NEDA (No Evidence of Disease Activity) - Radiological

    Time frame: Months 3 to 15

    A participant is considered as achieved NEDA-radiological if the participant has has no new radiological MRI activity (no new occurrences of contrast-enhancing lesions) during study Months 3 to 15.

  6. Mean change in The Symbol-Digit Modality Test

    Time frame: Baseline, Months 3 and 15

    This test measures cognition in patients with MS. Patients are asked to substitute a number, either orally or written, for randomized presentations of geometric figures.

  7. Mean change in the Time 25 Foot Walk

    Time frame: Baseline, Months 3 and 15

    This is a test of mobility and leg function. The patient is instructed to one end of a marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time to complete the test is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is performed again when the patient is directed to walk back the same distance. A walking device is permitted during this test.

  8. Mean change in the 9 Hole Peg Test

    Time frame: Baseline, Months 3 and 15

    This is a test of upper extremity function. The patient is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. The patient picks up the nine pegs one at a time as quickly as possible, puts them in nine holes and once they are in the holes, the patient removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. This test is performed with both the dominant and non-dominant hand.

  9. Mean change in Gd+ lesion count

    Time frame: Baseline, Months 3 and 15

    Increase in the number of contrast-enhancing lesions on MRI

  10. Mean change in Gd+ lesion volume

    Time frame: Baseline, Months 3 and 15

    Increase in size of contrast-enhancing lesions on MRI

  11. Mean change in T2 lesion count

    Time frame: Baseline, Months 3 and 15

    Increase in new T2 lesions on MRI

  12. Mean change in T2 lesion volume

    Time frame: Baseline, Months 3 and 15

    Increase in size of T2 lesions on MRI

  13. Mean change from Baseline in T1

    Time frame: Baseline up to Month 15

    Presence of new or enlarged T1 lesions

  14. Mean change in MSQOL-54

    Time frame: Month 3 to Month 15

    The MSQOL-54 is health-related quality of life questionnaire that assesses the physical, mental, and social effects experienced by MS patients, as well as functional disability. It is made up for 54 questions with a total score ranging from.0 to 100. Higher scores indicate better quality of life.

  15. Mean whole brain and regional volume loss from Baseline

    Time frame: Baseline up to Month 15

    Brain volume loss is a marker of progressive loss of brain structure and function. It is a predictor of disability progression.

  16. Percentage of participants reporting treatment emergent adverse events (TEAEs) and serious adverse events

    Time frame: Baseline up to Month 15

    Adverse events (TEAEs) and serious adverse events will be reported at each visit

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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)

Acronym: SOSTOS

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 22, 2021
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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