drugset / Trial / NCT02222948
Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vatelizumab | Monoclonal antibody | — | Intravenous |