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

Primary Purpose

Relapsing-remitting Multiple Sclerosis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vatelizumab
Placebo (for 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 - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 840004
  • Investigational Site Number 840009
  • Investigational Site Number 840005
  • Investigational Site Number 840014
  • Investigational Site Number 840007
  • Investigational Site Number 840012
  • Investigational Site Number 840001
  • Investigational Site Number 840015
  • Investigational Site Number 840003
  • Investigational Site Number 840016
  • Investigational Site Number 840002
  • Investigational Site Number 840008
  • Investigational Site Number 124001
  • Investigational Site Number 124002
  • Investigational Site Number 616008
  • Investigational Site Number 616007
  • Investigational Site Number 616001
  • Investigational Site Number 616004
  • Investigational Site Number 616003
  • Investigational Site Number 616002
  • Investigational Site Number 616006
  • Investigational Site Number 643010
  • Investigational Site Number 643009
  • Investigational Site Number 643003
  • Investigational Site Number 643005
  • Investigational Site Number 643006
  • Investigational Site Number 643008
  • Investigational Site Number 643002
  • Investigational Site Number 643011
  • Investigational Site Number 643001
  • Investigational Site Number 752002
  • Investigational Site Number 752001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Vatelizumab Dose 1

Vatelizumab Dose 2

Vatelizumab Dose 3

Vatelizumab Dose 4

Placebo

Arm Description

Vatelizumab dose 1 at Weeks 0, 2, 4 and 8

Vatelizumab dose 2 at Weeks 0, 2, 4 and 8

Vatelizumab dose 3 at Weeks 0, 2, 4 and 8

Vatelizumab dose 4 at Weeks 0, 2, 4 and 8

Placebo (for Vatelizumab) at Weeks 0, 2, 4 and 8

Outcomes

Primary Outcome Measures

Reduction in the cumulative number of new contrast-enhancing lesions on MRI

Secondary Outcome Measures

Safety: proportion of patients experiencing adverse events
Pharmacokinetics: serum concentrations of vatelizumab

Full Information

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

Unique Protocol Identification Number
NCT02222948
Brief Title
Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
Acronym
EMPIRE
Official 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)
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
September 2014 (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 Objectives: To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in new contrast-enhancing lesions (CELs) in relapsing remitting multiple sclerosis (RRMS) patients. To evaluate multiple doses of vatelizumab for a dose-response. Secondary Objectives: To evaluate the safety and tolerability of vatelizumab compared to placebo. To evaluate the pharmacokinetics (PK) of vatelizumab.
Detailed Description
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.

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
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vatelizumab Dose 1
Arm Type
Experimental
Arm Description
Vatelizumab dose 1 at Weeks 0, 2, 4 and 8
Arm Title
Vatelizumab Dose 2
Arm Type
Experimental
Arm Description
Vatelizumab dose 2 at Weeks 0, 2, 4 and 8
Arm Title
Vatelizumab Dose 3
Arm Type
Experimental
Arm Description
Vatelizumab dose 3 at Weeks 0, 2, 4 and 8
Arm Title
Vatelizumab Dose 4
Arm Type
Experimental
Arm Description
Vatelizumab dose 4 at Weeks 0, 2, 4 and 8
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (for Vatelizumab) at Weeks 0, 2, 4 and 8
Intervention Type
Drug
Intervention Name(s)
Vatelizumab
Other Intervention Name(s)
SAR339658
Intervention Description
Pharmaceutical form: solution for infusion Route of administration: intravenous
Intervention Type
Drug
Intervention Name(s)
Placebo (for Vatelizumab)
Intervention Description
Pharmaceutical form: solution for infusion Route of administration: intravenous
Primary Outcome Measure Information:
Title
Reduction in the cumulative number of new contrast-enhancing lesions on MRI
Time Frame
from Week 4 to Week 12
Secondary Outcome Measure Information:
Title
Safety: proportion of patients experiencing adverse events
Time Frame
up to Week 104
Title
Pharmacokinetics: serum concentrations of vatelizumab
Time Frame
up to Week 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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 840009
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85060
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 840014
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
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 840012
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
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 840015
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
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 840002
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
Investigational Site Number 840008
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Investigational Site Number 124001
City
Greenfield Park
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Investigational Site Number 124002
City
QuebeC
Country
Canada
Facility Name
Investigational Site Number 616008
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Investigational Site Number 616007
City
Lodz
ZIP/Postal Code
90-549
Country
Poland
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
70-111
Country
Poland
Facility Name
Investigational Site Number 616006
City
Warszawa
ZIP/Postal Code
02-653
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 643003
City
Moscow
ZIP/Postal Code
127018
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 643011
City
St-Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Investigational Site Number 643001
City
St-Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Investigational Site Number 752002
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
Facility Name
Investigational Site Number 752001
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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