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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2017
• Main ID: NCT02222948
• Date of registration: 20/08/2014
• Prospective Registration: Yes
• Primary sponsor: Genzyme, a Sanofi Company
• Public title: Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis EMPIRE
• Scientific 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)
• Date of first enrolment: September 2014
• Target sample size: 112
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02222948
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Canada, Poland, Russian Federation, Sweden, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria:

Diagnosis of relapsing-remitting multiple sclerosis (RRMS). At least 1 documented relapse
in the past 12 months. At least 1 contrast-enhancing lesion (CEL) on magnetic resonance
imaging (MRI) in the past 12 months and/or at screening.

At least 3 T2 lesions on screening MRI.

Exclusion criteria:

Diagnosis of primary progressive or secondary progressive MS. Expanded disability status
scale (EDSS) score >5.5. Relapse within 30 days prior to enrollment. Prior
immunosuppressive treatment within protocol-specified time periods. Prior treatment with
natalizumab (Tysabri®). History of bleeding/platelet disorders, malignancy, certain
infections as defined in the protocol, or any other past or current medical conditions
that would adversely affect the patient's participation in the study.

Pregnancy or breast-feeding. Other protocol-defined inclusion/exclusion criteria may
apply.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Relapsing-remitting Multiple Sclerosis

Intervention(s)

Drug: Vatelizumab

Drug: Placebo (for Vatelizumab)

Primary Outcome(s)

Reduction in the cumulative number of new contrast-enhancing lesions on MRI [Time Frame: from Week 4 to Week 12]

Secondary Outcome(s)

Safety: proportion of patients experiencing adverse events [Time Frame: up to Week 104]

Pharmacokinetics: serum concentrations of vatelizumab [Time Frame: up to Week 32]

Secondary ID(s)

U1111-1153-3840

DRI13839

2014-001643-20

Source(s) of Monetary Support

Please refer to primary and secondary sponsors