Evaluation of administration of gevokizumab versus placebo on the reduction of atheroma plaque inflammation.

• Conditions: Arterial wall inflammation in patients with marked atherosclerotic plaque inflammation; MedDRA version: 14.1Level: LLTClassification code 10002892Term: Aortic atherosclerosisSystem Organ Class: 100000004866; MedDRA version: 14.1Level: LLTClassification code 10057703Term: Coronary atherosclerosis of non-autologous biological bypass graftSystem Organ Class: 100000004849; MedDRA version: 14.1Level: LLTClassification code 10011095Term: Coronary atherosclerosis of native coronary arterySystem Organ Class: 100000004849; MedDRA version: 14.1Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 100000004866; MedDRA version: 14.1Level: LLTClassification code 10058152Term: Coronary atherosclerosis of bypass graftSystem Organ Class: 100000004849; MedDRA version: 14.1Level: LLTClassification code 10011094Term: Coronary atherosclerosis of autologous biological bypass graftSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; MedDRA version: 14.1Level: LLTClassification code 10018104Term: Generalized and unspecified atherosclerosisSystem Organ Class: 100000004866; MedDRA version: 14.1Level: LLTClassification code 10011093Term: Coronary atherosclerosisSystem Organ Class: 100000004849

• Registration Number: EUCTR2012-002677-53-NL
• Lead Sponsor: Institut de Recherches Internationales Servier (I.R.I.S.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-02
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ­The primary objective is to evaluate the effect of gevokizumab on arterial wall inflammation reduction following a recent Acute Coronary Syndrome (ACS);Secondary Objective: The secondary objectives are to evaluate:<br>- the effect of gevokizumab on cardiac and vascular biological blood biomarkers,<br>- the safety profile of gevokizumab,<br>- gevokizumab pharmacokinetics.;Primary end point(s): Changes from baseline of mean TBR;Timepoint(s) of evaluation of this end point: At inclusion and after 12 weeks of treatment. <br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - The changes from baseline of hs-CRP and IL-6 plasma concentrations,<br>- The changes from baseline of plasma concentrations of cytokines<br>- The changes from baseline in monocytes count.<br>- Safety measurements;Timepoint(s) of evaluation of this end point: - hs-CRP, IL-6 and other blood biomarkers : at W000, W004, W016 and W028<br>- Safety measurements : from selection until the end of the study