Relapsing-remitting Multiple Sclerosis Clinical Trial
Official title:
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)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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