Brief Summary:
Primary Objective: To determine the efficacy of SAR442168 in reducing the number of new brain lesions reported in Magnetic Resonance Imaging (MRI)
Secondary Objectives:
- To evaluate the efficacy of SAR442168 on clinical symptoms and imaging measures
- To evaluate the safety and tolerability of SAR442168
Detailed Description: The total study duration is 24 weeks which includes a screening period of 4 weeks, a treatment period of 16 weeks and a follow-up period of up to 4 weeks. Participants completing the Week 16 visit will be proposed to enroll in a long-term safety (LTS) follow-up study to assess safety and tolerability of SAR442168.
Study Type: | Interventional(Clinical Trial) |
Estimated Enrollment: | 120 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2b Dose-finding Study for SAR442168, a Bruton’s Tyrosine Kinase Inhibitor, in Participants With Relapsing Multiple Sclerosis |
ActualStudy Start Date: | February 21, 2019 |
EstimatedPrimary Completion Date: | December 2019 |
EstimatedStudy Completion Date: | December 2019 |
Patients who are diagnosed with Relapsing Multiple Sclerosis may qualify for a new study titled “Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis”. More information is available in the study pamphlet and on https://clinicaltrials.gov/ct2/show/NCT03889639?term=dri15928&rank=1.