A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of JK07 in Adults With Chronic Heart Failure (RENEU-HF)
Overview
- Phase
- Phase 2
- Intervention
- JK07
- Conditions
- Not specified
- Sponsor
- Salubris Biotherapeutics Inc
- Enrollment
- 282
- Locations
- 62
- Primary Endpoint
- Safety - Cohort 2
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure.
There will be 2 cohorts in this study:
Cohort 1: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) of ≤ 40%.
Cohort 2: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) > 40% and ≤ 65%.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants with New York Heart Association (NYHA) Class II-III.
- •Cohort 1 - Left Ventricular Ejection Fraction (LVEF) ≤ 40%.
- •Cohort 2 - Left Ventricular Ejection Fraction (LVEF) \>40% and ≤ 65%, elevated N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥ 600pg/mL and atrial fibrillation/flutter.
- •Stable heart failure and on optimal medical therapy.
- •Screening hemoglobin ≥ 9.0 g/dL.
Exclusion Criteria
- •Uncontrolled hypertension.
- •Sustained systolic Blood Pressure (BP) \< 90 mmHg and/or diastolic BP \< 50 mmHg on 2 consecutive (duplicate seated) readings at screening.
- •Heart failure due to hypertrophic cardiomyopathy, restrictive and/or infiltrative cardiomyopathy, arrhythmogenic right ventricular dysplasia, Fabry disease, or Noonan syndrome with LV hypertrophy or a positive serum immunofixation result.
- •Diagnosis of stress-induced (Takotsubo) cardiomyopathy, myocarditis, or peripartum cardiomyopathy.
- •Diagnosis of chemotherapy- or radiation-induced cardiomyopathy.
- •Diagnosed with stroke or Transient Ischemic Attack (TIA) within 12 weeks of screening.
- •History of syncope within the last 12 weeks prior to screening or sustained ventricular tachycardia without an implantable cardioverter-defibrillator.
- •Moderate or severe aortic and/or mitral valve stenosis.
- •Medically documented unstable angina, acute coronary syndrome (e.g., myocardial infarction, troponin-positive with symptoms of angina or unstable angina) within the last 8 weeks prior to start of screening.
- •Medically documented ST-elevation myocardial infarction within 12 weeks of screening.
Arms & Interventions
JK07 low dose
JK07 administered by intravenous (IV) infusion
Intervention: JK07
JK07 high dose
JK07 administered by intravenous (IV) infusion
Intervention: JK07
Placebo
Placebo administered by intravenous (IV) infusion
Intervention: Placebo
Outcomes
Primary Outcomes
Safety - Cohort 2
Time Frame: Study entry through week 52
Incidence and severity of treatment emergent adverse events
Safety - Cohort 1
Time Frame: Study entry through week 52
Incidence and severity of treatment emergent adverse events
Efficacy - Cohort 1
Time Frame: Baseline through week 26
Change in LVEF measured by 2D-TTE