A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation
SOSTOS
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)
1 other identifier
interventional
136
2 countries
43
Brief 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. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2022
Longer than P75 for phase_4
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2021
CompletedFirst Posted
Study publicly available on registry
October 22, 2021
CompletedStudy Start
First participant enrolled
March 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 13, 2027
March 30, 2026
March 1, 2026
5.1 years
October 12, 2021
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Months 3 to 15
Secondary Outcomes (16)
Percentage of participants with a single baseline NfL≥10pg/ml and NfL<10pg/ml achieving NEDA-3 (No Evidence of Disease Activity-3)
Months 3 to15
Annualized relapse rate in Months 3 to 15
Months 3 to 15
Percentage of participants without a worsening of their disability
Months 3 to 15
Percentage of participants with NEDA (No Evidence of Disease Activity) - Clinical
Months 3 to 15
Percentage of participants with NEDA (No Evidence of Disease Activity) - Radiological
Months 3 to 15
- +11 more secondary outcomes
Study Arms (2)
Ofatumumab
EXPERIMENTAL20 mg
DMT continued therapy
ACTIVE COMPARATORParticipants randomized to the continued therapy arm will continue to take their disease modifying treatment (DMT) as prescribed commercially by their physician.
Interventions
Other DMT with approved label use for treatment which participants were on at least 6 months prior to Screening
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Alabama Neurology Associates PC
Birmingham, Alabama, 35209, United States
North Central Neurology Associates PC
Cullman, Alabama, 35058, United States
Radiant Research Chandler
Chandler, Arizona, 85224, United States
Arizona Neuroscience Research LLC
Phoenix, Arizona, 85032, United States
University of California at Los Angeles
Torrance, California, 90509-2004, United States
Neurology of Central FL Res Ctr
Altamonte Springs, Florida, 32714, United States
S And D Clinical Research
Cape Coral, Florida, 33904, United States
Homestead Assoc In Research Inc
Homestead, Florida, 33033, United States
Neurology Associates PA
Maitland, Florida, 32751, United States
Orlando Health Clinical Trials
Orlando, Florida, 32806, United States
Emerald Coast Neurology
Pensacola, Florida, 32514, United States
University Of South Florida
Tampa, Florida, 33612, United States
Kootenai Health
Coeur d'Alene, Idaho, 83815, United States
Neuro Medial Clinic of Central Louisiana
Alexandria, Louisiana, 71301, United States
International Neurorehab Institute
Lutherville, Maryland, 21093, United States
Reliant Medical Group
Worcester, Massachusetts, 01608, United States
Henry Ford Hospital
Detroit, Michigan, 48202-2689, United States
Memorial Healthcare
Owosso, Michigan, 48867, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505, United States
St Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Jersey Shore University Medical Ctr
Neptune City, New Jersey, 07753, United States
SUNY Upstate Medical Center
Syracuse, New York, 13210, United States
University Of NC At Chapel Hill
Chapel Hill, North Carolina, 27599 9500, United States
Piedmont HealthCare
Charlotte, North Carolina, 28210, United States
Velocity Clinical Research
Raleigh, North Carolina, 27607, United States
Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, 37922, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Neuro Mind Clinical Trials Ltd Co
Katy, Texas, 77449, United States
Covenant Medical Group
Lubbock, Texas, 79410, United States
West Texas Cancer Center
Odessa, Texas, 79761, United States
Tranquil Clinical Research
Webster, Texas, 77598, United States
Sentara Neuroscience Institute
Virginia Beach, Virginia, 23456, United States
Evergreen Health Multiple Sclerosis Center
Kirkland, Washington, 98034, United States
Swedish Medical Center
Seattle, Washington, 98122-4379, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Novartis Investigative Site
Edmonton, Alberta, T6G 2B7, Canada
Novartis Investigative Site
Burnaby, British Columbia, V5G 2X6, Canada
Novartis Investigative Site
Vancouver, British Columbia, V6T 2A1, Canada
Novartis Investigative Site
Granby, Quebec, J2G 1T7, Canada
Novartis Investigative Site
Lévis, Quebec, G6W 0M5, Canada
Novartis Investigative Site
Saskatoon, Saskatchewan, S7K 0M7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2021
First Posted
October 22, 2021
Study Start
March 2, 2022
Primary Completion (Estimated)
April 13, 2027
Study Completion (Estimated)
April 13, 2027
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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