A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNovartis Pharmaceuticals
About this trial
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent must be obtained prior to any assessment performed.
Male or female participants aged 18-65 (inclusive) at Screening.
Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018), with current SPMS in accordance with the revised clinical course (Lublin et al 2014) at Screening
Absence of documented clinical relapses in the 24 months before Screening and randomization.
Disqualifiers
Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)).
History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS).
Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability to cooperate and comply with the study procedures.
Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML.
Trial design
Design model
Parallel
Treatments tested in this trial
Remibrutinib (blinded)
DrugRemibrutinib (Blinded) active treatment, oral tablet
Placebo
DrugMatching placebo (binded), oral tablet
Remibrutinib (Open label)
DrugRemibrutinib (Open Label), oral tablet
Treatment groups
1,275 Participants
are divided into 2 treatment groupsGroup A: Remibrutinib (LOU064)Experimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Time 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 yearsSecondary outcomes
1
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 years2
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 years3
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.
Time frame
From baseline up to approximately 5 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov