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

This study has been terminated.
(Study discontinued based on planned interim analysis of the primary endpoint. Not linked to any safety concern.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02222948
First Posted: August 22, 2014
Last Update Posted: December 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
  Purpose

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.

Condition Intervention Phase
Relapsing-remitting Multiple Sclerosis Drug: Vatelizumab Drug: Placebo (for Vatelizumab) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Primary Outcome Measures:
  • Reduction in the cumulative number of new contrast-enhancing lesions on MRI [ Time Frame: from Week 4 to Week 12 ]

Secondary Outcome Measures:
  • Safety: proportion of patients experiencing adverse events [ Time Frame: up to Week 104 ]
  • Pharmacokinetics: serum concentrations of vatelizumab [ Time Frame: up to Week 32 ]

Enrollment: 112
Study Start Date: September 2014
Study Completion Date: July 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vatelizumab Dose 1
Vatelizumab dose 1 at Weeks 0, 2, 4 and 8
Drug: Vatelizumab

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Other Name: SAR339658
Experimental: Vatelizumab Dose 2
Vatelizumab dose 2 at Weeks 0, 2, 4 and 8
Drug: Vatelizumab

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Other Name: SAR339658
Experimental: Vatelizumab Dose 3
Vatelizumab dose 3 at Weeks 0, 2, 4 and 8
Drug: Vatelizumab

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Other Name: SAR339658
Experimental: Vatelizumab Dose 4
Vatelizumab dose 4 at Weeks 0, 2, 4 and 8
Drug: Vatelizumab

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Other Name: SAR339658
Placebo Comparator: Placebo
Placebo (for Vatelizumab) at Weeks 0, 2, 4 and 8
Drug: Placebo (for Vatelizumab)

Pharmaceutical form: solution for infusion

Route of administration: intravenous


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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222948


  Show 32 Study Locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02222948     History of Changes
Other Study ID Numbers: DRI13839
2014-001643-20 ( EudraCT Number )
U1111-1153-3840 ( Other Identifier: UTN )
First Submitted: August 20, 2014
First Posted: August 22, 2014
Last Update Posted: December 21, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases