A Phase 2 interventional study of Vatelizumab and Placebo (for Vatelizumab) in Relapsing-remitting Multiple Sclerosis, sponsored by Genzyme, a Sanofi Company. Terminated at 32 sites in 5 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-12-21.
Sponsored by Genzyme, a Sanofi Company · Phase 2, Interventional, and Treatment
Primary Objectives:
Secondary Objectives:
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 112 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Genzyme, a Sanofi Company is the lead sponsor of 303 studies on the registry; 5 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Vatelizumab dose 1 at Weeks 0, 2, 4 and 8
Drug: Vatelizumab
Vatelizumab dose 2 at Weeks 0, 2, 4 and 8
Drug: Vatelizumab
Vatelizumab dose 3 at Weeks 0, 2, 4 and 8
Drug: Vatelizumab
Vatelizumab dose 4 at Weeks 0, 2, 4 and 8
Drug: Vatelizumab
Placebo (for Vatelizumab) at Weeks 0, 2, 4 and 8
Drug: Placebo (for Vatelizumab)
Pharmaceutical form: solution for infusion Route of administration: intravenous
Also known as: SAR339658
Pharmaceutical form: solution for infusion Route of administration: intravenous
Reduction in the cumulative number of new contrast-enhancing lesions on MRI
Time frame: from Week 4 to Week 12
Safety: proportion of patients experiencing adverse events
Time frame: up to Week 104
Pharmacokinetics: serum concentrations of vatelizumab
Time frame: up to Week 32
This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Genzyme, a Sanofi Company