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Relapsing-Remitting Multiple SclerosisPhase 4SOSTOSNCT05090371

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

A Phase 4 study testing Ofatumumab and Disease modifying treatment (DMT) in people with Relapsing-Remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 43 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Relapsing-Remitting Multiple Sclerosis
What is being tested?
Ofatumumab and Disease modifying treatment (DMT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
43 sitesin 2 countries
Study dates
2 Mar 2022to 13 Apr 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

43 sites in 2 countries.

43 sites in 2 countries

United States37 sites

  • Neuro Medial Clinic of Central Louisiana

    Alexandria, Louisiana, 71301

  • Neurology of Central FL Res Ctr

    Altamonte Springs, Florida, 32714

  • Alabama Neurology Associates PC

    Birmingham, Alabama, 35209

  • S And D Clinical Research

    Cape Coral, Florida, 33904

  • Radiant Research Chandler

    Chandler, Arizona, 85224

  • University Of NC At Chapel Hill

    Chapel Hill, North Carolina, 27599 9500

  • Piedmont HealthCare

    Charlotte, North Carolina, 28210

  • Kootenai Health

    Coeur d'Alene, Idaho, 83815

  • North Central Neurology Associates PC

    Cullman, Alabama, 35058

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2689

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Homestead Assoc In Research Inc

    Homestead, Florida, 33033

  • Clinical Trial Network

    Houston, Texas, 77074

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Neuro Mind Clinical Trials Ltd Co

    Katy, Texas, 77449

  • Evergreen Health Multiple Sclerosis Center

    Kirkland, Washington, 98034

  • Sibyl Wray MD Neurology PC

    Knoxville, Tennessee, 37922

  • St Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Covenant Medical Group

    Lubbock, Texas, 79410

  • International Neurorehab Institute

    Lutherville, Maryland, 21093

  • Neurology Associates PA

    Maitland, Florida, 32751

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Jersey Shore University Medical Ctr

    Neptune City, New Jersey, 07753

  • West Texas Cancer Center

    Odessa, Texas, 79761

  • Orlando Health Clinical Trials

    Orlando, Florida, 32806

  • Memorial Healthcare

    Owosso, Michigan, 48867

  • Emerald Coast Neurology

    Pensacola, Florida, 32514

  • Arizona Neuroscience Research LLC

    Phoenix, Arizona, 85032

  • Velocity Clinical Research

    Raleigh, North Carolina, 27607

  • Swedish Medical Center

    Seattle, Washington, 98122-4379

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • SUNY Upstate Medical Center

    Syracuse, New York, 13210

  • University Of South Florida

    Tampa, Florida, 33612

  • University of California at Los Angeles

    Torrance, California, 90509-2004

  • Sentara Neuroscience Institute

    Virginia Beach, Virginia, 23456

  • Tranquil Clinical Research

    Webster, Texas, 77598

  • Reliant Medical Group

    Worcester, Massachusetts, 01608

Other trials in United States

Canada6 sites

  • Novartis Investigative Site

    Burnaby, British Columbia, V5G 2X6

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 2B7

  • Novartis Investigative Site

    Granby, Quebec, J2G 1T7

  • Novartis Investigative Site

    Lévis, Quebec, G6W 0M5

  • Novartis Investigative Site

    Saskatoon, Saskatchewan, S7K 0M7

  • Novartis Investigative Site

    Vancouver, British Columbia, V6T 2A1

Other trials in Canada

About this study

Official 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)

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.

Read the detailed 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.

Being tested
Ofatumumab, Disease modifying treatment (DMT)
Keywords
Ofatumumab, Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, adult, OMB157, RRMS, MS, secondary progressive MS, relapse
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OfatumumabDrug

    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

Study groups in NCT05090371
Study groupRoleWhat they receive
OfatumumabExperimental20 mg
Receives: Drug: Ofatumumab
DMT continued therapyActive comparatorParticipants randomized to the continued therapy arm will continue to take their disease modifying treatment (DMT) as prescribed commercially by their physician.
Receives: Drug: Disease modifying treatment (DMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Months 3 to 15

Secondary outcomes (16)

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

    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)

    Measured: Months 3 to15

  2. Annualized relapse rate in 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.

    Measured: Months 3 to 15

  3. Percentage of participants without a worsening of their disability

    No increase or worsening of disability

    Measured: Months 3 to 15

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

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

    Measured: Months 3 to 15

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

    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.

    Measured: Months 3 to 15

  6. Mean change in The Symbol-Digit Modality Test

    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.

    Measured: Baseline, Months 3 and 15

  7. Mean change in the Time 25 Foot Walk

    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.

    Measured: Baseline, Months 3 and 15

  8. Mean change in the 9 Hole Peg Test

    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.

    Measured: Baseline, Months 3 and 15

  9. Mean change in Gd+ lesion count

    Increase in the number of contrast-enhancing lesions on MRI

    Measured: Baseline, Months 3 and 15

  10. Mean change in Gd+ lesion volume

    Increase in size of contrast-enhancing lesions on MRI

    Measured: Baseline, Months 3 and 15

  11. Mean change in T2 lesion count

    Increase in new T2 lesions on MRI

    Measured: Baseline, Months 3 and 15

  12. Mean change in T2 lesion volume

    Increase in size of T2 lesions on MRI

    Measured: Baseline, Months 3 and 15

  13. Mean change from Baseline in T1

    Presence of new or enlarged T1 lesions

    Measured: Baseline up to Month 15

  14. Mean change in MSQOL-54

    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.

    Measured: Month 3 to Month 15

  15. Mean whole brain and regional volume loss from Baseline

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

    Measured: Baseline up to Month 15

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

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

    Measured: Baseline up to Month 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2021
  2. Study start2 Mar 2022
  3. Primary completion13 Apr 2027 (estimated)
  4. Study completion13 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized, open label, multi-center, active-comparator study
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05090371
Sponsor's protocol ID
COMB157GUS09
Acronym
SOSTOS
Status last verified
May 2026
First submitted
12 Oct 2021
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ofatumumab and Disease modifying treatment (DMT) in people with Relapsing-Remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 43 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3) (time frame: Months 3 to 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05090371.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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