E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063399 |
E.1.2 | Term | Relapsing-remitting multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in new contrast-enhancing lesions (CELs) in RRMS patients
To evaluate mutiple doses of vatelizumab for a dose-response.
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of vatelizumab compared to placebo
To evaluate the pharmacokinetics (PK) of vatelizumab
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Sub study 1 : The purpose of the CSF clinical research project is to study certain types of immune cells and proteins in the CSF sample to determine the effects of vatelizumab and possible risks associated with using vatelizumab.
Sub study 2 : The purpose of this sub study is to collect a blood sample to obtain DNA for the investigation of DNA differences that may affect how the body responds to (including possible side effects) and how the body handles the study drug (vatelizumab).
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E.3 | Principal 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 month and / or at screening.
At least 3 T2 lesions on screening MRI.
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction in the cumulative number of new CELs on MRI compared to placebo |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Safety: proportion of patients experiencing adverse events
Pharmacokinetics: serum concentrations of vatelizumab |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Safety: proportion of patients experiencing adverse events: up to 32 weeks
Pharmacokinetics: serum concentrations of vatelizumab: up to 32 weeks |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 5 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 33 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Czech Republic |
Germany |
Italy |
Mexico |
Poland |
Russian Federation |
Sweden |
Switzerland |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |