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

Sponsor
Genzyme, a Sanofi Company (Industry)
Overall Status
Terminated
CT.gov ID
NCT02306811
Collaborator
(none)
62
Enrollment
18
Locations
4
Arms
17
Duration (Months)
3.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:

To assess the long-term safety of vatelizumab in MS patients

Secondary Objective:

To assess the long-term efficacy of vatelizumab

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Jul 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vatelizumab Dose 1

Vatelizumab dose 1 every 4 weeks (Q4W) for 96 weeks

Drug: Vatelizumab
Pharmaceutical form:solution for infusion Route of administration: intravenous
Other Names:
  • SAR339658

    		•
    Experimental: Vatelizumab Dose 2

    Vatelizumab dose 2 every 4 weeks (Q4W) for 96 weeks

    Drug: Vatelizumab
    Pharmaceutical form:solution for infusion Route of administration: intravenous
    Other Names:
  • SAR339658

    		•
    Experimental: Vatelizumab Dose 3

    Vatelizumab dose 3 every 4 weeks (Q4W) for 96 weeks

    Drug: Vatelizumab
    Pharmaceutical form:solution for infusion Route of administration: intravenous
    Other Names:
  • SAR339658

    		•
    Experimental: Vatelizumab Dose 4

    Vatelizumab dose 4 every 4 weeks (Q4W) for 96 weeks

    Drug: Vatelizumab
    Pharmaceutical form:solution for infusion Route of administration: intravenous
    Other Names:
  • SAR339658

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients experiencing adverse events [from Week 0 to Week 192]

    Secondary Outcome Measures

    1. Change in total volume of T2 lesions [from Week 0 to Week 84]

    2. Change in number of T1 hypointense lesions [from Week 0 to Week 84]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number 840004 Cullman Alabama United States 35058
    2 Investigational Site Number 840005 Fort Collins Colorado United States 80528
    3 Investigational Site Number 840007 Ormond Beach Florida United States 32174
    4 Investigational Site Number 840001 Latham New York United States 12210
    5 Investigational Site Number 840003 Round Rock Texas United States 78681
    6 Investigational Site Number 840016 San Antonio Texas United States 78258
    7 Investigational Site Number 124001 Greenfield Park Canada J4V 2J2
    8 Investigational Site Number 616001 Lodz Poland 93-121
    9 Investigational Site Number 616004 Lublin Poland 20-090
    10 Investigational Site Number 616003 Lublin Poland 20-718
    11 Investigational Site Number 616002 Szczecin Poland 70-215
    12 Investigational Site Number 643010 Kazan Russian Federation 420021
    13 Investigational Site Number 643009 Moscow Russian Federation 107150
    14 Investigational Site Number 643005 Nizhniy Novgorod Russian Federation 603155
    15 Investigational Site Number 643006 Nizhny Novgorod Russian Federation 603076
    16 Investigational Site Number 643008 Novosibirsk Russian Federation 630087
    17 Investigational Site Number 643002 St-Petersburg Russian Federation 197089
    18 Investigational Site Number 643001 St-Petersburg Russian Federation 197376

    Sponsors and Collaborators

    • Genzyme, a Sanofi Company

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genzyme, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT02306811
    Other Study ID Numbers:
    • LTS13840
    • 2014-003265-19
    • U1111-1160-6120
    First Posted:
    Dec 3, 2014
    Last Update Posted:
    Dec 21, 2016
    Last Verified:
    Dec 1, 2016
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Multiple Sclerosis, Relapsing-Remitting
    Sclerosis

    Study Results

    No Results Posted as of Dec 21, 2016