NCT02222948

Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Primary Objectives: * To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in new contrast-enhancing lesions (CELs) in relapsing remitting multiple sclerosis (RRMS) patients. * To evaluate multiple doses of vatelizumab for a dose-response. Secondary Objectives: * To evaluate the safety and tolerability of vatelizumab compared to placebo. * To evaluate the pharmacokinetics (PK) of vatelizumab.

Detailed description

The duration of study per patient will be up to 108 weeks, including a screening period of up to 4 weeks, a treatment period of 12 weeks and a post-treatment safety follow-up period of up to 92 weeks. Patients completing the 12-week treatment period may enter an optional long-term extension study in which all subjects will receive vatelizumab.

Conditions

• Relapsing-remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Vatelizumab	Pharmaceutical form: solution for infusion Route of administration: intravenous
DRUG	Placebo (for Vatelizumab)	Pharmaceutical form: solution for infusion Route of administration: intravenous

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-04-01
• Completion: 2016-07-01
• First posted: 2014-08-22
• Last updated: 2016-12-21

Locations

32 sites across 5 countries: United States, Canada, Poland, Russia, Sweden