The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, parallel-group, event-driven study to evaluate the efficacy, safety and tolerability of remibrutinib in SPMS patients. Approximately 1275 eligible participants will be randomized to receive either remibrutinib or matching placebo. The study consists of an event-driven Core Part with double-blind treatment, followed by an Extension Part with open-label remibrutinib treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,275
Remibrutinib (Blinded) active treatment, oral tablet
Matching placebo (binded), oral tablet
Remibrutinib (Open Label), oral tablet
Alabama Neurology Associates PC
Birmingham, Alabama, United States
RECRUITINGTime to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)
The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). 6mCDP is defined as an increase from baseline in EDSS sustained for at least 6 months.
Time frame: From baseline up to approximately 5 years
Time to 3-month confirmed disability progression (3mCDP) on EDSS
The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). 3mCDP is defined as an increase from baseline in EDSS sustained for at least 3 months.
Time frame: From baseline up to approximately 5 years
Time to 6-month confirmed disability improvement (6mCDI) on EDSS
The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). A 6mCDI is defined as a decrease from baseline in EDSS sustained for at least 6 months.
Time frame: From baseline up to approximately 5 years
Time to 3-month worsening by at least 20% in Timed 25-Foot Walk (T25FW)
The T25FW is an ambulation measurement assessing speed of walking: a timed (in seconds) walk of 25 feet (7.62 meters). Longer time indicates poorer lower limb function. 3-month worsening by at least 20% in T25FW is defined as an increase from baseline in T25FW of at least 20% sustained for at least 3 months.
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AZ Integrated Neuro and Spine
Phoenix, Arizona, United States
Neurology of Central FL Res Ctr
Altamonte Springs, Florida, United States
RECRUITINGOrlando Health Clinical Trials
Orlando, Florida, United States
RECRUITINGNeurology Associates of Ormond Beach
Ormond Beach, Florida, United States
RECRUITINGMid Atlantic Epilepsy and Sleep Ctr
Bethesda, Maryland, United States
RECRUITINGMichigan Institute of Neurological
Farmington Hills, Michigan, United States
RECRUITINGNeurology Clinic PC
Cordova, Tennessee, United States
RECRUITINGNovartis Investigative Site
Kogarah, New South Wales, Australia
RECRUITINGNovartis Investigative Site
Heidelberg, Victoria, Australia
RECRUITING...and 7 more locations
Time frame: From baseline up to approximately 5 years
Time to 3-month worsening by at least 20% in 9-Hole Peg Test (9-HPT)
The 9-HPT is an objective quantitative test of neurological function. It is measured to assess both right and left arm scores, the metric is the time, in seconds, required to insert and remove 9 pegs. Longer time indicates poorer upper limb function. A 3-month worsening by at least 20% in 9-HPT is defined as an increase from baseline in 9-HPT of at least 20% sustained for at least 3 months
Time frame: From baseline up to approximately 5 years
Annualized rate of new or enlarging T2 lesions
Number of new or enlarging T2 lesions per year based on MRI
Time frame: From baseline up to approximately 5 years
Annualized rate of brain atrophy
Percentage change in brain volume relative to baseline per year based on MRI assessments
Time frame: From baseline up to approximately 5 years
Time to 6-month worsening by at least 4 points in Symbol Digit Modalities Test (SDMT)
The SDMT is a sensitive and specific test to assess information processing speed which is typically affected in cognitively impaired MS participants, The test scoring is calculated based on the number of correct answers in 90 seconds. A 6-month worsening by at least 4 points in SDMT is defined as an increase from baseline in SDMT of at least 4 points sustained for at least 6 months.
Time frame: From baseline up to approximately 5 years
Number of participants with Adverse events and Serious adverse events (SAE)
Incidence of adverse events including changes in laboratory data, vital signs, electrocardiogram (ECG) and Columbia Suicide Severity Rating Scale (C-SSRS) qualifying and reported as AEs.
Time frame: From baseline up to approximately 5 years