drugset / Trial / NCT02222948

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

NCT02222948 ↗

Phase 2 Terminated 112 enrolled Genzyme, a Sanofi Company
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2014-09
Primary completion
2016-04
Completion
2016-07

Outcome

Outcome not reported

Stopped: “Study discontinued based on planned interim analysis of the primary endpoint. Not linked to any safety concern.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Vatelizumab Monoclonal antibody — Intravenous