CURRENT RECRUITING TRIALS
For more information about recruiting trials, contact the MS Team at ms-cru.neuro@mcgill.ca.
Relapsing Remitting MS
NOVARTIS ELIOS
ELIOS – Investigational Biomarkers to Track Disease Modification in Active RRMS (ELIOS)
The exploratory ELIOS study aims to assess the value of novel investigational Eye Movement Biomarkers (EMBs) in tracking disease-related changes among a real-world cohort of Canadian patients with active RRMS, within the context of disease-modifying treatment (i.e., ofatumumab).
To that end, the study will use the patented investigational, Eye Tracking Neurological Assessment (ETNA-ProgMS) SaMD (v1.0.11 or later), which has not yet received Health Canada approval, to reliably and accurately track eye movements with precision.
ROCHE BRAIN SHUTTLE
The purpose of this study is to test the safety of the RO7121932 at different dose levels; determine how well it is tolerated; measure how the body absorbs, distributes, and gets rid of it (this is called “pharmacokinetics” [PK]); and find out what effects RO7121932 has.
RO7121932 combines an antibody with a “brain shuttle” module, which delivers it to the brain. Antibodies act like your body’s immune system and attach themselves to certain cells to attack germs and other illnesses in your body.
The Study Drug attaches to certain types of white blood cells (B cells) and reduces their number. These B cells, especially those in the brain, are thought to play a role in MS.
Primary Progressive MS
ROCHE BRAIN SHUTTLE
The purpose of this study is to test the safety of the RO7121932 at different dose levels; determine how well it is tolerated; measure how the body absorbs, distributes, and gets rid of it (this is called “pharmacokinetics” [PK]); and find out what effects RO7121932 has.
RO7121932 combines an antibody with a “brain shuttle” module, which delivers it to the brain. Antibodies act like your body’s immune system and attach themselves to certain cells to attack germs and other illnesses in your body.
The Study Drug attaches to certain types of white blood cells (B cells) and reduces their number. These B cells, especially those in the brain, are thought to play a role in MS.
Secondary Progressive MS
ROCHE BRAIN SHUTTLE
The purpose of this study is to test the safety of the RO7121932 at different dose levels; determine how well it is tolerated; measure how the body absorbs, distributes, and gets rid of it (this is called “pharmacokinetics” [PK]); and find out what effects RO7121932 has.
RO7121932 combines an antibody with a “brain shuttle” module, which delivers it to the brain. Antibodies act like your body’s immune system and attach themselves to certain cells to attack germs and other illnesses in your body.
The Study Drug attaches to certain types of white blood cells (B cells) and reduces their number. These B cells, especially those in the brain, are thought to play a role in MS.
MOGAD
ROCHE METEOROID
The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period.
UPCOMING TRIALS
Relapsing Remitting MS
BMS BALANCE
MODERNA mRNA-1195-P201
Primary Progressive MS
BMS BALANCE
A Phase 2, Randomized, Double-Blind, Four-Arm, Placebo-Controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Three Doses of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Spasticity in Participants With Multiple Sclerosis (BALANCE-MSS-1). The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity.
MODERNA mRNA-1195-P201
VOT
Secondary Progressive MS
BMS BALANCE
A Phase 2, Randomized, Double-Blind, Four-Arm, Placebo-Controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Three Doses of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Spasticity in Participants With Multiple Sclerosis (BALANCE-MSS-1). The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity.
MODERNA mRNA-1195-P201
CIS (Clinically Isolated Syndrome) / RIS (Radiologically Isolated Syndrome)
MODERNA mRNA-1195-P201
ACTIVE (NOT RECRUITING) TRIALS
Relapsing Remitting MS
ALITHIOS
This research study will try to answer to the following questions:
· How well does ofatumumab work in reducing relapses, disease worsening, and brain lesions seen on magnetic resonance imaging (MRI) compared to teriflunomide?
· How safe is treatment with ofatumumab, and how well is ofatumumab tolerated?
· How does ofatumumab affect the body?
· Is there a way to predict how ofatumumab will help in the course of MS from results of special laboratory tests and MRI scans?
FENHANCE
The purpose of this study is to compare the effects, good or bad, of fenebrutinib versus teriflunomide on patients with RMS.
For this study, 734 male and female participants will be recruited globally. The participants will be aged between 18-55 years.
OLERO
This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.
SANOFI PASS
A prospective, multicenter, observational, post-authorization safety study (PASS) to evaluate the long term safety profile of LEMTRADA (alemtuzumab) treatment in patients with relapsing forms of multiple sclerosis
The purpose of this study is to collect information for a period of 10 years after your first dose of LEMTRADA, which will include information about your disease, related treatment history, and information to help to obtain a good understanding of potential side effects after treatment with LEMTRADA.
SANOFI LTS17043
This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 [EFC16033], GEMINI 2 [EFC16034], HERCULES [EFC16645], or PERSEUS [EFC16035]).
Primary Progressive MS
CALLIPER IMMUNIC-AG
This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU838 in adult patients with PMS. The study will consist of the following periods:
Screening Period: Approximately 28 days Main Treatment Period: Up to 120 weeks (approximately 2 years) Open Label Extension Period: Up to approximately 8 years.
GAVOTTE
This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with PPMS, in comparison to the approved 600 mg dose of ocrelizumab.
OLERO
This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.
PERSEUS
The purpose of this study is to see if the study drug works to delay the progression of disability in people with PPMS compared to placebo and has an acceptable safety profile.
For this study, approximately 990 male and female participants with PPMS will be recruited at numerous sites worldwide including Canada. The participants will be aged between 18-55 years.
SANOFI LTS17043
This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 [EFC16033], GEMINI 2 [EFC16034], HERCULES [EFC16645], or PERSEUS [EFC16035]).
Secondary Progressive MS
CALLIPER IMMUNIC-AG
This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU838 in adult patients with PMS. The study will consist of the following periods:
Screening Period: Approximately 28 days Main Treatment Period: Up to 120 weeks (approximately 2 years) Open Label Extension Period: Up to approximately 8 years.
SANOFI LTS17043
This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 [EFC16033], GEMINI 2 [EFC16034], HERCULES [EFC16645], or PERSEUS [EFC16035]).
MS TEAM
Dr. A. Saveriano
Principal Investigator
Dr. Simon Thebault
Principal Investigator
Dr. Paul Giacomini
Principal Investigator
Sophie Morris
Clinical Research Coordinator
Dr. Adil Harroud
Principal Investigator
Dr. M. Lévesque-Roy
Principal Investigator
Michael Pileggi
Team Lead