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

• ClinicalTrials.gov Identifier: NCT02222948
• Recruitment Status: Terminated
• First Posted: August 22, 2014
• Last Update Posted: December 21, 2016
• Sponsor: Genzyme, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Genzyme, a Sanofi Company )

Tracking Information

• First Submitted Date: August 20, 2014
• First Posted Date: August 22, 2014
• Last Update Posted Date: December 21, 2016
• Study Start Date: September 2014
• Actual Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 27, 2016): Reduction in the cumulative number of new contrast-enhancing lesions on MRI [ Time Frame: from Week 4 to Week 12 ]
• Original Primary Outcome Measures (submitted: August 20, 2014): Reduction in the cumulative number of new contrast-enhancing lesions on MRI compared to placebo [ Time Frame: from Week 4 to Week 12 ]

Current Secondary Outcome Measures (submitted: April 27, 2016)

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

Original Secondary Outcome Measures (submitted: August 20, 2014)

• Safety: proportion of patients experiencing adverse events [ Time Frame: up to 32 weeks ]
• Pharmacokinetics: serum concentrations of vatelizumab [ Time Frame: up to 32 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
• 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)

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Relapsing-remitting Multiple Sclerosis

Intervention

• Drug: Vatelizumab

  Pharmaceutical form: solution for infusion

  Route of administration: intravenous

  Other Name: SAR339658
• Drug: Placebo (for Vatelizumab)

  Pharmaceutical form: solution for infusion

  Route of administration: intravenous

Study Arms

• Experimental: Vatelizumab Dose 1
  Vatelizumab dose 1 at Weeks 0, 2, 4 and 8
  Intervention: Drug: Vatelizumab
• Experimental: Vatelizumab Dose 2
  Vatelizumab dose 2 at Weeks 0, 2, 4 and 8
  Intervention: Drug: Vatelizumab
• Experimental: Vatelizumab Dose 3
  Vatelizumab dose 3 at Weeks 0, 2, 4 and 8
  Intervention: Drug: Vatelizumab
• Experimental: Vatelizumab Dose 4
  Vatelizumab dose 4 at Weeks 0, 2, 4 and 8
  Intervention: Drug: Vatelizumab
• Placebo Comparator: Placebo
  Placebo (for Vatelizumab) at Weeks 0, 2, 4 and 8
  Intervention: Drug: Placebo (for Vatelizumab)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 12, 2016): 112
• Original Estimated Enrollment (submitted: August 20, 2014): 168
• Actual Study Completion Date: July 2016
• Actual Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Poland, Russian Federation, Sweden, United States

Administrative Information

• NCT Number: NCT02222948
• Other Study ID Numbers: DRI13839; 2014-001643-20 ( EudraCT Number ); U1111-1153-3840 ( Other Identifier: UTN )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
• Original Responsible Party: Same as current
• Current Study Sponsor: Genzyme, a Sanofi Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

• PRS Account: Sanofi
• Verification Date: December 2016