Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839

Study Overview
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Brief Summary
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Primary Objective: To assess the long-term safety of vatelizumab in MS patients Secondary Objective: To assess the long-term efficacy of vatelizumab

Detailed Description
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The maximum study duration per patient will be 192 weeks, including a Treatment Period of 96 weeks and Post-treatment Safety Follow-up Period of 96 weeks.

Official Title
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A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839

Conditions
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Relapsing-remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: Vatelizumab


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients who completed the 12-week treatment period in DRI13839. Exclusion criteria: Any clinically significant or ongoing adverse events, or laboratory abnormalities from DRI13839 that per Investigator judgment would adversely affect the patient's participation in the long-term extension study. Confirmed platelet count below the lower limit of normal at any time during DRI13839. Pregnancy or breast-feeding. Other protocol defined 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vatelizumab Dose 1<br>Vatelizumab dose 1 every 4 weeks (Q4W) for 96 weeks | Drug: Vatelizumab<br>* Pharmaceutical form:solution for infusion Route of administration: intravenous<br>* Other names: SAR339658;|
| Experimental: Vatelizumab Dose 2<br>Vatelizumab dose 2 every 4 weeks (Q4W) for 96 weeks | Drug: Vatelizumab<br>* Pharmaceutical form:solution for infusion Route of administration: intravenous<br>* Other names: SAR339658;|
| Experimental: Vatelizumab Dose 3<br>Vatelizumab dose 3 every 4 weeks (Q4W) for 96 weeks | Drug: Vatelizumab<br>* Pharmaceutical form:solution for infusion Route of administration: intravenous<br>* Other names: SAR339658;|
| Experimental: Vatelizumab Dose 4<br>Vatelizumab dose 4 every 4 weeks (Q4W) for 96 weeks | Drug: Vatelizumab<br>* Pharmaceutical form:solution for infusion Route of administration: intravenous<br>* Other names: SAR339658;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients experiencing adverse events |  | from Week 0 to Week 192 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total volume of T2 lesions |  | from Week 0 to Week 84 | 
| Change in number of T1 hypointense lesions |  | from Week 0 to Week 84 |