A 12-week, multi-center, double-blinded, parallelgroup, randomized, placebo-controlled phase IIb study to evaluate the safety, tolerability and efficacy of IZD334 to reduce CRP in cardiovascular high-risk patients.

Phase 2

Withdrawn

Conditions: artherosclerosis
coronary artery disease (CAD)
10011082

Registration Number: NL-OMON49686

Lead Sponsor: Inflazome Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 132

Inclusion Criteria

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

Exclusion Criteria

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the safety and tolerability of oral IZD334 in patients with high<br /><br>cardiovascular risk<br /><br>To evaluate the efficacy of IZD334 measuring the percent change from baseline<br /><br>of 450mg IZD334 compared to placebo in plasma CRP after 12 weeks of treatment</p><br>

Secondary Outcome Measures