E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Arterial wall inflammation in patients with marked atherosclerotic plaque inflammation |
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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] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057703 |
E.1.2 | Term | Coronary atherosclerosis of non-autologous biological bypass graft |
E.1.2 | System Organ Class | 100000004849 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058152 |
E.1.2 | Term | Coronary atherosclerosis of bypass graft |
E.1.2 | System Organ Class | 100000004849 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018104 |
E.1.2 | Term | Generalized and unspecified atherosclerosis |
E.1.2 | System Organ Class | 100000004866 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002892 |
E.1.2 | Term | Aortic atherosclerosis |
E.1.2 | System Organ Class | 100000004866 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011093 |
E.1.2 | Term | Coronary atherosclerosis |
E.1.2 | System Organ Class | 100000004849 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003603 |
E.1.2 | Term | Atherosclerosis generalized |
E.1.2 | System Organ Class | 100000004866 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011095 |
E.1.2 | Term | Coronary atherosclerosis of native coronary artery |
E.1.2 | System Organ Class | 100000004849 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003605 |
E.1.2 | Term | Atherosclerosis of aorta |
E.1.2 | System Organ Class | 100000004866 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051615 |
E.1.2 | Term | Atherosclerotic cardiovascular disease |
E.1.2 | System Organ Class | 100000004866 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011094 |
E.1.2 | Term | Coronary atherosclerosis of autologous biological bypass graft |
E.1.2 | System Organ Class | 100000004849 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011076 |
E.1.2 | Term | Coronary artery atherosclerosis |
E.1.2 | System Organ Class | 100000004849 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011097 |
E.1.2 | Term | Coronary atherosclerosis of unspecified vessel |
E.1.2 | System Organ Class | 100000004849 |
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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 |
The primary objective is to evaluate the effect of gevokizumab on arterial wall inflammation reduction following a recent Acute Coronary Syndrome (ACS) |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate:
- the effect of gevokizumab on cardiac and vascular biological blood biomarkers,
- the safety profile of gevokizumab,
- gevokizumab pharmacokinetics. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- A maximum mean TBR (target to background ratio) > 1.8 centrally measured in any region of interest.
- A stable use of statins since at least 2 months.
- 50 years of age or older
- A documented recent (3-12 months, inclusive) acute coronary syndrome (ACS)
- Completion of all revascularisation procedures, 3 months before at least |
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E.4 | Principal exclusion criteria |
- Positive HIV, Hepatitis C antibody and Hepatitis B antigen.
- Evidences of TB infection
- Type 1 diabetes and uncontrolled type 2 diabète
- Urinary incontinence
- Corrected QT interval duration (Bazett’s formula) > 450 ms for a male and 470 ms for a female measured at inclusion visit or Family history of long QT syndrome or congenital long QT syndrome.
- Chronic inflammatory disease
- History of malignancy within 3 years prior to Selection
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- Infectious disease
- History or symptoms of a demyelinating disease
- History of coronary artery bypass graft
- Hemodynamic instability including hypotension, marked congestive heart failure.
- Severe or uncontrolled hypertension, or systolic blood pressure < 90 mmHg. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes from baseline of mean TBR |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At inclusion and after 12 weeks of treatment.
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E.5.2 | Secondary end point(s) |
- The changes from baseline of hs-CRP and IL-6 plasma concentrations,
- The changes from baseline of plasma concentrations of cytokines
- The changes from baseline in monocytes count.
- Safety measurements |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- hs-CRP, IL-6 and other blood biomarkers : at W000, W004, W016 and W028
- Safety measurements : from selection until the end of the study |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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 |
Finland |
Netherlands |
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E.8.7 | Trial has a data monitoring committee | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |