NCT03889639

Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis

A Phase 2b Dose-finding Study for SAR442168, a Bruton's Tyrosine Kinase Inhibitor, in Participants With Relapsing Multiple Sclerosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To determine the dose-response relationship for SAR442168 to reduce the number of new active brain lesions. Secondary Objectives: * To evaluate efficacy of SAR442168 on disease activity as assessed by imaging measures. * To evaluate the safety and tolerability of SAR442168.

Detailed description

The total study duration was 24 weeks which included a screening period of 4 weeks, a treatment period of 16 weeks, and a follow-up period of up to 4 weeks. Participants who completed the Week 16 visit were proposed to be enrolled in a long-term extension safety and efficacy study to assess safety, tolerability and efficacy of SAR442168.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	SAR442168	Pharmaceutical form: Film coated tablet; Route of administration: Oral
DRUG	Placebo	Pharmaceutical form: Film coated tablet; Route of administration: Oral
DRUG	Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)	Pharmaceutical form: Solution for injection; Route of administration: Intravenous

Timeline

• Start date: 2019-03-29
• Primary completion: 2020-01-02
• Completion: 2020-01-02
• First posted: 2019-03-26
• Last updated: 2025-09-17
• Results posted: 2023-03-08

Locations

48 sites across 10 countries: United States, Canada, Czechia, Estonia, France, Netherlands, Russia, Slovakia, Spain, Ukraine

Regulatory

• FDA-regulated drug study