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

Evaluation of the subcutaneous administration of 30 mg of S 78989 versus placebo and evaluation of the subcutaneous administration of 60 mg of S 78989 versus placebo on the reduction of arterial wall inflammation in patients with marked atherosclerotic plaque inflammation. A 28-weeks, randomised, double-blind, parallel-group, placebo controlled, international multicentre exploratory pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002677-53-FI

Enrollment

Registered

2012-09-20

Start date

2012-12-19

Completion date

Unknown

Last updated

2015-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial wall inflammation in patients with marked atherosclerotic plaque inflammation MedDRA version: 16.0 Level: LLT Classification code 10057703 Term: Coronary atherosclerosis of non-autologous biological bypass graft System Organ Class: 100000004849 MedDRA version: 16.0 Level: LLT Classification code 10058152 Term: Coronary atherosclerosis of bypass graft System Organ Class: 100000004849 MedDRA version: 16.0 Level: LLT Classification code 10018104 Term: Generalized and unspecified atheros

Interventions

Product Name: Gevokizumab Product Code: S78989 Pharmaceutical Form: Solution for injection INN or Proposed INN: gevokizumab CAS Number: 1129435-60-4 Current Sponsor code: S78989 Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - A mean maximum TBR (target to background ratio) > 1.8 centrally measured in any region of interest. - No change in use of statin and other antidyslipidemic treatments since selection visit - 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 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36

Exclusion criteria

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 selection 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 at selection. - Introduction or modification of any anti-dyslipidemic drug treatment other than statin in the two months prior to Selection - Patient with any internal device or prosthesis.

Design outcomes

Primary

Measure	Time frame
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: - the effect of gevokizumab on cardiac and vascular biological blood biomarkers, - the safety profile of gevokizumab, - gevokizumab pharmacokinetics.;Primary end point(s): Changes from baseline of TBR;Timepoint(s) of evaluation of this end point: At inclusion and after 12 weeks of treatment.	—

Measure

Time frame

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: - the effect of gevokizumab on cardiac and vascular biological blood biomarkers, - the safety profile of gevokizumab, - gevokizumab pharmacokinetics.;Primary end point(s): Changes from baseline of TBR;Timepoint(s) of evaluation of this end point: At inclusion and after 12 weeks of treatment.

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Secondary

Measure	Time frame
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;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	—

Measure

Time frame

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;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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Countries

Canada, Finland, Netherlands

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33 1 55 72 43 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026