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
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.

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