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

Primary Purpose

Relapsing-remitting Multiple Sclerosis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vatelizumab
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-remitting Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 840004
  • Investigational Site Number 840005
  • Investigational Site Number 840007
  • Investigational Site Number 840001
  • Investigational Site Number 840003
  • Investigational Site Number 840016
  • Investigational Site Number 124001
  • Investigational Site Number 616001
  • Investigational Site Number 616004
  • Investigational Site Number 616003
  • Investigational Site Number 616002
  • Investigational Site Number 643010
  • Investigational Site Number 643009
  • Investigational Site Number 643005
  • Investigational Site Number 643006
  • Investigational Site Number 643008
  • Investigational Site Number 643002
  • Investigational Site Number 643001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Vatelizumab Dose 1

Vatelizumab Dose 2

Vatelizumab Dose 3

Vatelizumab Dose 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Proportion of patients experiencing adverse events

Secondary Outcome Measures

Change in total volume of T2 lesions
Change in number of T1 hypointense lesions

Full Information

First Posted
December 1, 2014
Last Updated
December 20, 2016
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT02306811
Brief Title
Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839
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 Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Study discontinued based on planned interim analysis of the primary endpoint. Not linked to any safety concern.
Study Start Date
February 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-remitting Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vatelizumab Dose 1
Arm Type
Experimental
Arm Description
Vatelizumab dose 1 every 4 weeks (Q4W) for 96 weeks
Arm Title
Vatelizumab Dose 2
Arm Type
Experimental
Arm Description
Vatelizumab dose 2 every 4 weeks (Q4W) for 96 weeks
Arm Title
Vatelizumab Dose 3
Arm Type
Experimental
Arm Description
Vatelizumab dose 3 every 4 weeks (Q4W) for 96 weeks
Arm Title
Vatelizumab Dose 4
Arm Type
Experimental
Arm Description
Vatelizumab dose 4 every 4 weeks (Q4W) for 96 weeks
Intervention Type
Drug
Intervention Name(s)
Vatelizumab
Other Intervention Name(s)
SAR339658
Intervention Description
Pharmaceutical form:solution for infusion Route of administration: intravenous
Primary Outcome Measure Information:
Title
Proportion of patients experiencing adverse events
Time Frame
from Week 0 to Week 192
Secondary Outcome Measure Information:
Title
Change in total volume of T2 lesions
Time Frame
from Week 0 to Week 84
Title
Change in number of T1 hypointense lesions
Time Frame
from Week 0 to Week 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840004
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Investigational Site Number 840005
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Investigational Site Number 840007
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Investigational Site Number 840001
City
Latham
State/Province
New York
ZIP/Postal Code
12210
Country
United States
Facility Name
Investigational Site Number 840003
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Investigational Site Number 840016
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Investigational Site Number 124001
City
Greenfield Park
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Investigational Site Number 616001
City
Lodz
ZIP/Postal Code
93-121
Country
Poland
Facility Name
Investigational Site Number 616004
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Investigational Site Number 616003
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Investigational Site Number 616002
City
Szczecin
ZIP/Postal Code
70-215
Country
Poland
Facility Name
Investigational Site Number 643010
City
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
Investigational Site Number 643009
City
Moscow
ZIP/Postal Code
107150
Country
Russian Federation
Facility Name
Investigational Site Number 643005
City
Nizhniy Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Investigational Site Number 643006
City
Nizhny Novgorod
ZIP/Postal Code
603076
Country
Russian Federation
Facility Name
Investigational Site Number 643008
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Investigational Site Number 643002
City
St-Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Investigational Site Number 643001
City
St-Petersburg
ZIP/Postal Code
197376
Country
Russian Federation

12. IPD Sharing Statement

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

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