Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis (EMPIRE)
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| ClinicalTrials.gov Identifier: NCT02222948 |
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Recruitment Status :
Terminated
(Study discontinued based on planned interim analysis of the primary endpoint. Not linked to any safety concern.)
First Posted : August 22, 2014
Last Update Posted : December 21, 2016
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Relapsing-remitting Multiple Sclerosis | Drug: Vatelizumab Drug: Placebo (for Vatelizumab) | Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 112 participants |
| 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) |
| Study Start Date : | September 2014 |
| Actual Primary Completion Date : | April 2016 |
| Actual Study Completion Date : | July 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Vatelizumab Dose 1
Vatelizumab dose 1 at Weeks 0, 2, 4 and 8
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Drug: Vatelizumab
Pharmaceutical form: solution for infusion Route of administration: intravenous Other Name: SAR339658 |
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Experimental: Vatelizumab Dose 2
Vatelizumab dose 2 at Weeks 0, 2, 4 and 8
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Drug: Vatelizumab
Pharmaceutical form: solution for infusion Route of administration: intravenous Other Name: SAR339658 |
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Experimental: Vatelizumab Dose 3
Vatelizumab dose 3 at Weeks 0, 2, 4 and 8
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Drug: Vatelizumab
Pharmaceutical form: solution for infusion Route of administration: intravenous Other Name: SAR339658 |
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Experimental: Vatelizumab Dose 4
Vatelizumab dose 4 at Weeks 0, 2, 4 and 8
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Drug: Vatelizumab
Pharmaceutical form: solution for infusion Route of administration: intravenous Other Name: SAR339658 |
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Placebo Comparator: Placebo
Placebo (for Vatelizumab) at Weeks 0, 2, 4 and 8
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Drug: Placebo (for Vatelizumab)
Pharmaceutical form: solution for infusion Route of administration: intravenous |
- Reduction in the cumulative number of new contrast-enhancing lesions on MRI [ Time Frame: from Week 4 to Week 12 ]
- Safety: proportion of patients experiencing adverse events [ Time Frame: up to Week 104 ]
- Pharmacokinetics: serum concentrations of vatelizumab [ Time Frame: up to Week 32 ]
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 |
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.
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
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| Study Director: | Clinical Sciences & Operations | Sanofi |
| Responsible Party: | Genzyme, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT02222948 |
| Other Study ID Numbers: |
DRI13839 2014-001643-20 ( EudraCT Number ) U1111-1153-3840 ( Other Identifier: UTN ) |
| First Posted: | August 22, 2014 Key Record Dates |
| Last Update Posted: | December 21, 2016 |
| Last Verified: | December 2016 |
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Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS |
Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |