A study investigating the safety, tolerability and efficacy of IZD334 in patients with high cardiovascular risk
- Conditions
- Patients with stable coronary artery disease and high cardiovascular riskMedDRA version: 20.0Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2020-000942-32-NL
- Lead Sponsor
- Inflazome Ireland Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 132
1. Signed and dated informed consent form obtained before any study assessment is performed
2. Male or female patients aged =18 years
3. Stable coronary artery disease (CAD) where stable coronary artery disease refers to any of the following:
a. a reversible supply/demand mismatch related to ischemia or
b. a history of myocardial infarction (minimum 30 days prior to
randomization) or
c. the presence of coronary artery plaque of any severity
documented by cardiac catheterization or computed tomography angiography.
Patients are considered stable if they are asymptomatic or their symptoms are adequately controlled by medications or revascularization.
4. Elevated plasma CRP level of = 2 mg/L at screening visit 1 (local lab) and confirmed at screening visit 2 by central lab
5. Negative pregnancy test for females of child-bearing potential (premenopausal, ? 2 years post-menopausal, not surgically sterile)
6. Stable concomitant medication for at least 4 weeks prior to randomization
7. Patients with creatinine clearance ? 30 mL/min/1.73m2 by the MDRD (modification of diet in renal disease) equation may be included
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 92
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1. Any use of NSAIDs or steroids or cholchicine or anti-IL-1 inhibitors within 4 weeks prior to randomization (ASS 100mg as part of SOC treatment is allowed / topical, inhaled, local steroid use in doses that are not considered to cause systemic effects are permitted)
2. Any investigational drugs or participation in a clinical trial within 4 weeks or five half-lives (whichever is longer) prior to randomization
3. Active systemic infections (other than common cold) during the two weeks prior to randomization
4. Positive test for hepatitis B virus surface antigen (HBsAg) or Hepatitis C virus RNA at screening
5. Positive test for HIV at screening
6. History of severe hypersensitivity according to the investigator’s judgement to previous drugs of similar chemical classes
7. Any severe, progressive or uncontrolled medical condition at baseline that in the judgment of the investigator prevents the patient from participating in the study including uncontrolled hypertension, uncontrolled diabetes and severe hepatic disease
8. Symptomatic patients with Class IV heart failure (HF) (New York Heart Association)
9. Planned Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG)
10. Any clinically significant abnormal laboratory tests at screening
11. A history of alcohol and/or substance abuse that could interfere with the conduct of the trial
12. Inability or unwillingness to undergo repeated venipunctures (e.g., due to poor tolerability or lack of access to veins)
13. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (HCG) laboratory test (> 5 mIU/mL)
14. Women of childbearing potential unwilling or unable to practice effective method of contraception
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method