Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis

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
Actual Study Start Date: March 29, 2019
Estimated Primary Completion Date: December 2019
Estimated Study Completion Date: December 2019

Arms:
- Experimental: Arm 1 (12 weeks of SAR442186 dose 1 followed by 4 weeks of Placebo)
- Experimental: Arm 2 (12 weeks of SAR442186 dose 2 followed by 4 weeks of Placebo)
- Experimental: Arm 3 (12 weeks of SAR442186 dose 3 followed by 4 weeks of Placebo)
- Experimental: Arm 4 (12 weeks of SAR442186 dose 4 followed by 4 weeks of Placebo)
- Experimental: Arm 5 (4 weeks of Placebo followed by 12 weeks of SAR442186 dose 1)
- Experimental: Arm 6 (4 weeks of Placebo followed by 12 weeks of SAR442186 dose 2)
- Experimental: Arm 7 (4 weeks of Placebo followed by 12 weeks of SAR442186 dose 3)
- Experimental: Arm 8 (4 weeks of Placebo followed by 12 weeks of SAR442186 dose 4)