A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study of YMI024 to Assess Efficacy in Reducing Inflammatory Markers, Safety, and Tolerability in Adults With Stable Coronary Artery Disease and Elevated hsCRP
Novartis Pharmaceuticals
Summary
The purpose of this Phase 2b study is to investigate the efficacy in reducing systemic inflammation, safety, tolerability, and dose response of five doses of YMI024, as compared to placebo in adult participants with stable coronary artery disease (CAD) and residual inflammatory risk defined by elevated high-sensitivity C-reactive protein (hsCRP) (≥2 mg/L)
Description
Participants are randomized in a 1:1:1:1:1:1 ratio to one of the six arms, with stratification by comorbidity status at randomization: CAD-only, CAD+ (Heart Failure) HF, and CAD+Chronic Kidney Disease (CKD), and receive study medication on top of stable standard-of-care therapies. The study employs double-blinding, concealing treatment allocation from participants, Investigators, Sponsor, and study staff, with identical packaging and labelling, schedule of administration and appearance for all study drugs.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed informed consent must be obtained prior to any study specific procedures, and participant able to understand and comply with study requirements. 2. Male and female participants aged between 18-80 years (inclusive) at Screening. 3. Documented stable CAD as evidenced by presence of at least one of the following criteria: 1. Documented history of spontaneous (Type 1) myocardial infarction (MI) of presumed atherosclerotic origin that occurred at least 30 days before the start of Screening. If a Pre-screening visit is conducted, the MI must have occurred at least…
Interventions
- DrugYMI024
YMI024 in different doses
- DrugPlacebo
matching placebo
Locations (23)
- Eastern Shore Research InstituteFairhope, Alabama
- G and L Research LLCFoley, Alabama
- Biopharma Informatic LLCLos Angeles, California
- AMR MiamiCoral Gables, Florida
- Alliance for Multispecialty ResearchWichita, Kansas
- Anderson Medical ResearchFt. Washington, Maryland