Relapsing Multiple Sclerosis Clinical Trial
Official title:
A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis
Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS Secondary Objective: To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate pharmacodynamics (PD) of SAR442168
Study duration will vary per participant in this event driven trial with a treatment duration of approximately 18 to 36 months. Participants completing the study will be offered to participate in a long term safety study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04121065 -
Role of ADA SNPs in Subjects With Relapsing Multiple Sclerosis (RMS)
|
||
| Active, not recruiting |
NCT03996291 -
Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis
|
Phase 2 | |
| Recruiting |
NCT04510220 -
9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis
|
Phase 3 | |
| Terminated |
NCT02241785 -
Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis (MS) After Failure on Other Therapies
|
Phase 4 | |
| Completed |
NCT02792218 -
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis
|
Phase 3 | |
| Completed |
NCT01412333 -
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
|
Phase 3 | |
| Completed |
NCT03257358 -
A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod
|
Phase 4 | |
| Completed |
NCT01628393 -
Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients
|
Phase 2/Phase 3 | |
| Completed |
NCT04626921 -
A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis
|
Phase 2/Phase 3 | |
| Withdrawn |
NCT02234869 -
Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon Therapy
|
Phase 4 | |
| Withdrawn |
NCT05077956 -
Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis
|
||
| Active, not recruiting |
NCT04486716 -
A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis
|
Phase 3 | |
| Recruiting |
NCT04121403 -
Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS)
|
Phase 3 | |
| Recruiting |
NCT05809986 -
Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
|
||
| Terminated |
NCT00988052 -
A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course
|
Phase 3 | |
| Active, not recruiting |
NCT05232825 -
A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis
|
Phase 3 | |
| Terminated |
NCT01047319 -
A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis
|
Phase 3 | |
| Completed |
NCT04847596 -
A Multicenter Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
|
||
| Completed |
NCT01127750 -
Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients
|
Phase 3 | |
| Completed |
NCT01006941 -
Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study
|
Phase 2 |