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

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)

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.

Study Overview

• Status: Terminated
• Conditions: Relapsing-remitting Multiple Sclerosis
• Intervention / Treatment: Drug: Vatelizumab; Drug: Placebo (for 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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Greenfield Park, Canada, J4V 2J2
    • Investigational Site Number 124001
  • QuebeC, Canada
    • Investigational Site Number 124002
• Poland
  • Bydgoszcz, Poland, 85-079
    • Investigational Site Number 616008
  • Lodz, Poland, 90-549
    • Investigational Site Number 616007
  • Lodz, Poland, 93-121
    • Investigational Site Number 616001
  • Lublin, Poland, 20-090
    • Investigational Site Number 616004
  • Lublin, Poland, 20-718
    • Investigational Site Number 616003
  • Szczecin, Poland, 70-111
    • Investigational Site Number 616002
  • Warszawa, Poland, 02-653
    • Investigational Site Number 616006
• Russian Federation
  • Kazan, Russian Federation, 420021
    • Investigational Site Number 643010
  • Moscow, Russian Federation, 107150
    • Investigational Site Number 643009
  • Moscow, Russian Federation, 127018
    • Investigational Site Number 643003
  • Nizhniy Novgorod, Russian Federation, 603155
    • Investigational Site Number 643005
  • Nizhny Novgorod, Russian Federation, 603076
    • Investigational Site Number 643006
  • Novosibirsk, Russian Federation, 630087
    • Investigational Site Number 643008
  • St-Petersburg, Russian Federation, 197089
    • Investigational Site Number 643002
  • St-Petersburg, Russian Federation, 197110
    • Investigational Site Number 643011
  • St-Petersburg, Russian Federation, 197376
    • Investigational Site Number 643001
• Sweden
  • Göteborg, Sweden, 416 85
    • Investigational Site Number 752002
  • Stockholm, Sweden, 171 76
    • Investigational Site Number 752001
• United States
  • Alabama
    • Cullman, Alabama, United States, 35058
      • Investigational Site Number 840004
  • Arizona
    • Phoenix, Arizona, United States, 85060
      • Investigational Site Number 840009
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • Investigational Site Number 840005
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Investigational Site Number 840014
  • Florida
    • Ormond Beach, Florida, United States, 32174
      • Investigational Site Number 840007
    • Tampa, Florida, United States, 33612
      • Investigational Site Number 840012
  • New York
    • Latham, New York, United States, 12210
      • Investigational Site Number 840001
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Investigational Site Number 840015
  • Texas
    • Round Rock, Texas, United States, 78681
      • Investigational Site Number 840003
    • San Antonio, Texas, United States, 78258
      • Investigational Site Number 840016
  • Utah
    • Salt Lake City, Utah, United States, 84103
      • Investigational Site Number 840002
  • Washington
    • Seattle, Washington, United States, 98122
      • Investigational Site Number 840008

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in the cumulative number of new contrast-enhancing lesions on MRI	from Week 4 to Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: proportion of patients experiencing adverse events	up to Week 104
Pharmacokinetics: serum concentrations of vatelizumab	up to Week 32

Collaborators and Investigators

• Sponsor: Genzyme, a Sanofi Company

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: August 20, 2014
• First Submitted That Met QC Criteria: August 20, 2014
• First Posted (ESTIMATE): August 22, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): December 21, 2016
• Last Update Submitted That Met QC Criteria: December 20, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: DRI13839; 2014-001643-20 (EUDRACT_NUMBER); U1111-1153-3840 (OTHER: UTN)