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RECRUITINGPhase 2INTERVENTIONAL

Study of JK07 in Patients With Chronic Heart Failure

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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%.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 blood count (hemoglobin) at least 9.0 g/dL. Who Should NOT Join This Trial: - 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. - Any tachycardia (inclusive of Atrial Fibrillation (AF) or atrial flutter) with a resting ventricular rate \> 110 beats per minute at screening. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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. * Any tachycardia (inclusive of Atrial Fibrillation (AF) or atrial flutter) with a resting ventricular rate \> 110 beats per minute at screening. * For participants with a history of AF or atrial flutter, not on adequate anticoagulant therapy via non-vitamin K oral anticoagulants or warfarin if the CHA2DS2-VASc score is ≥ 2 in men or ≥ 3 in women or per local guidelines. Percutaneous occlusion of the left atrial appendage alone is not adequate. * AF ablation within the last 12 weeks prior to screening or planned during the study duration. * Symptomatic bradycardia or second (Mobitz Type II)- or third-degree heart block without a pacemaker. * Cardiac surgery, coronary artery revascularization or indication for coronary artery revascularization, percutaneous coronary intervention, valve repair/replacement or valvuloplasty within 12 weeks prior to screening. * Implantation of a Cardiac Resynchronization Therapy (CRT) device within 12 weeks prior to screening, or intent to implant a CRT device during the course of the study. * Previous cardiac transplantation, or any use of mechanical circulatory support or similar device, or implantation expected after randomization. * Receiving mechanical hemodynamic support or invasive mechanical ventilation within the last 8 weeks prior to screening. * Receiving Intravenous (IV) inotropes or IV vasopressors within the last 8 weeks prior to screening. * Receiving IV vasodilators within the last 4 weeks prior to screening. * Receiving noninvasive mechanical ventilation within the last 4 weeks prior to screening. The use of noninvasive ventilation for sleep disordered breathing is permitted.

Treatments Being Tested

DRUG

JK07

JK07 is a fully human anti-human epidermal growth factor receptor 3 (also known as ErbB3 or HER3) antibody fused with the epidermal growth factor (EGF)-domain of Neuregulin (NRG)-1b protein.

DRUG

Placebo

0.9% sodium chloride

Locations (20)

Site 121
Alexander City, Alabama, United States
Site 130
Birmingham, Alabama, United States
Site 139
Birmingham, Alabama, United States
Site 138
Huntsville, Alabama, United States
Site 111
Phoenix, Arizona, United States
Site 127
Little Rock, Arkansas, United States
Site 128
Huntington Beach, California, United States
Site 157
Los Angeles, California, United States
Site 158
Orange, California, United States
Site 116
Pasadena, California, United States
Site 129
Santa Maria, California, United States
Site 102
Stanford, California, United States
Site 113
Torrance, California, United States
Site 133
Vista, California, United States
Site 161
Coral Gables, Florida, United States
Site 114
Hialeah, Florida, United States
Site 162
Miami Lakes, Florida, United States
Site 159
Naples, Florida, United States
Site 136
Atlanta, Georgia, United States
Site 143
Boise, Idaho, United States