CURRENT RECRUITING TRIALS
CONTACT US
(514) 398-5500 or ms-cru.neuro@mcgill.ca.
Relapsing Remitting MS
BMS BALANCE
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
BMS BALANCE
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
BMS BALANCE
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.
NOVARTIS REMASTER
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 purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS). The study consists of an event-driven Core Part with double-blind treatment, followed by an Extension Part with open-label remibrutinib treatment.
UPCOMING TRIALS
Relapsing Remitting MS
ASTRA ZENECA ZENITH
This study will evaluate AZD0120 for safety, including DLTs and TEAEs, by the SRC for determination of the Recommended Phase 2 dose for each disease cohort. Approximately 9-12 participants will be evaluated per disease cohort.
GILEAD KITE
This study will have two Phases: Phase 1a and Phase 1b. The goals of this clinical study are to learn more about the study drug KITE-363, by evaluating its safety, tolerability and efficacy in participants with relapsed/refractory autoimmune neurologic diseases.
The primary objectives of this study are:
- To evaluate the safety and tolerability of KITE-363 in participants with autoimmune neurologic diseases
- To determine the recommended dose for Phase 1b.
- To evaluate the preliminary efficacy of KITE-363 in participants with autoimmune neurologic diseases.
MODERNA mRNA-1195-P201
ROCHE OCTAVIBE (CN46182)
A phase III, open-label, single-arm, multi center study to evaluate the safety and use of an on-body delivery system for the subcutaneous home administration of ocrelizumab in patients with multiple sclerosis
The Roche OCTAVIBE (CN46182) study is a phase III, open-label, single-arm, multicenter clinical trial investigating the safety and usability of an on-body delivery system (OBDS) for drug administration
Primary Progressive MS
ASTRA ZENECA ZENITH
This study will evaluate AZD0120 for safety, including DLTs and TEAEs, by the SRC for determination of the Recommended Phase 2 dose for each disease cohort. Approximately 9-12 participants will be evaluated per disease cohort.
GILEAD KITE
This study will have two Phases: Phase 1a and Phase 1b. The goals of this clinical study are to learn more about the study drug KITE-363, by evaluating its safety, tolerability and efficacy in participants with relapsed/refractory autoimmune neurologic diseases.
The primary objectives of this study are:
- To evaluate the safety and tolerability of KITE-363 in participants with autoimmune neurologic diseases
- To determine the recommended dose for Phase 1b.
- To evaluate the preliminary efficacy of KITE-363 in participants with autoimmune neurologic diseases.
MODERNA mRNA-1195-P201
ROCHE OCTAVIBE (CN46182)
A phase III, open-label, single-arm, multi center study to evaluate the safety and use of an on-body delivery system for the subcutaneous home administration of ocrelizumab in patients with multiple sclerosis
The Roche OCTAVIBE (CN46182) study is a phase III, open-label, single-arm, multicenter clinical trial investigating the safety and usability of an on-body delivery system (OBDS) for drug administration
ZENAS MONARCH (ZB020-03-002))
Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.
Secondary Progressive MS
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.
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.
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. Adil Harroud
Principal Investigator
Dr. A. Saveriano
Principal Investigator
Sophie Morris
Team Lead
Polina Plitchenko
Clinical Research Coordinator
Dr. Simon Thebault
Principal Investigator
Dr. Paul Giacomini
Principal Investigator
Priya Patel
Clinical research coor
Kyra Schweers
Clinical research coordinator