Clinical trial NCT05090371: A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Ofatumumab
Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
adult
OMB157
RRMS
MS
secondary progressive MS
relapse
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-10-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, open label, multi-center, active-comparator study
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3)
timeFrame: Months 3 to 15
Secondary outcomes:
measure: Percentage of participants with a single baseline NfL≥10pg/ml and NfL<10pg/ml achieving NEDA-3 (No Evidence of Disease Activity-3)
timeFrame: Months 3 to15
measure: Annualized relapse rate in Months 3 to 15
timeFrame: Months 3 to 15
measure: Percentage of participants without a worsening of their disability
timeFrame: Months 3 to 15
measure: Percentage of participants with NEDA (No Evidence of Disease Activity) - Clinical
timeFrame: Months 3 to 15
measure: Percentage of participants with NEDA (No Evidence of Disease Activity) - Radiological
timeFrame: Months 3 to 15
measure: Mean change in The Symbol-Digit Modality Test
timeFrame: Baseline, Months 3 and 15
measure: Mean change in the Time 25 Foot Walk
timeFrame: Baseline, Months 3 and 15
measure: Mean change in the 9 Hole Peg Test
timeFrame: Baseline, Months 3 and 15
measure: Mean change in Gd+ lesion count
timeFrame: Baseline, Months 3 and 15
measure: Mean change in Gd+ lesion volume
timeFrame: Baseline, Months 3 and 15
measure: Mean change in T2 lesion count
timeFrame: Baseline, Months 3 and 15
measure: Mean change in T2 lesion volume
timeFrame: Baseline, Months 3 and 15
measure: Mean change from Baseline in T1
timeFrame: Baseline up to Month 15
measure: Mean change in MSQOL-54
timeFrame: Month 3 to Month 15
measure: Mean whole brain and regional volume loss from Baseline
timeFrame: Baseline up to Month 15
measure: Percentage of participants reporting treatment emergent adverse events (TEAEs) and serious adverse events
timeFrame: Baseline up to Month 15
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Neurology Associates PC
state: Alabama
city: Cullman
country: United States
facility: North Central Neurology Associates PC
state: Alabama
city: Phoenix
country: United States
facility: Arizona Neuroscience Research LLC
state: Arizona
city: Torrance
country: United States
facility: University of California at Los Angeles
state: California
city: Altamonte Springs
country: United States
facility: Neurology of Central FL Res Ctr
state: Florida
city: Cape Coral
country: United States
facility: S And D Clinical Research
state: Florida
city: Homestead
country: United States
facility: Homestead Assoc In Research Inc
state: Florida
city: Maitland
country: United States
facility: Neurology Associates PA
state: Florida
city: Orlando
country: United States
facility: Orlando Health Clinical Trials
state: Florida
city: Pensacola
country: United States
facility: Emerald Coast Neurology
state: Florida
city: Tampa
country: United States
facility: University Of South Florida
state: Florida
city: Coeur d'Alene
country: United States
facility: Kootenai Health
state: Idaho
city: Alexandria
country: United States
facility: Neuro Medial Clinic of Central Louisiana
state: Louisiana
city: Lutherville
country: United States
facility: International Neurorehab Institute
state: Maryland
city: Worcester
country: United States
facility: Reliant Medical Group
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Owosso
country: United States
facility: Memorial Healthcare
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Neptune
country: United States
facility: Jersey Shore University Medical Ctr
state: New Jersey
city: Syracuse
country: United States
facility: SUNY Upstate Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University Of NC At Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Piedmont HealthCare
state: North Carolina
city: Raleigh
country: United States
facility: Velocity Clinical Research
state: North Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Knoxville
country: United States
facility: Sibyl Wray MD Neurology PC
state: Tennessee
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Katy
country: United States
facility: Neuro Mind Clinical Trials Ltd Co
state: Texas
city: Lubbock
country: United States
facility: Covenant Medical Group
state: Texas
city: Odessa
country: United States
facility: West Texas Cancer Center
state: Texas
city: Webster
country: United States
facility: Tranquil Clinical Research
state: Texas
city: Virginia Beach
country: United States
facility: Sentara Neuroscience Institute
state: Virginia
city: Kirkland
country: United States
facility: Evergreen Health Multiple Sclerosis Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Burnaby
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Granby
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Levis
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Saskatoon
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
Study officials:
References: