Heart Failure With Reduced Ejection FractionHeart Failure With Preserved Ejection Fraction
Investigational drug(s) / intervention(s)
JK07Placebo
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.
Placebo: 0.9% sodium chloride
Study 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%.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Safety - Cohort 1 — Study entry through week 52 Incidence and severity of treatment emergent adverse events
Efficacy - Cohort 1 — Baseline through week 26 Change in LVEF measured by 2D-TTE
Safety - Cohort 2 — Study entry through week 52 Incidence and severity of treatment emergent adverse events
Trial sites (62)
Facility
City
Region
Status
Site 121
Alexander City
Alabama
Site 130
Birmingham
Alabama
Site 139
Birmingham
Alabama
Site 138
Huntsville
Alabama
Site 111
Phoenix
Arizona
Site 127
Little Rock
Arkansas
Site 128
Huntington Beach
California
Site 157
Los Angeles
California
Site 158
Orange
California
Site 116
Pasadena
California
Site 129
Santa Maria
California
Site 102
Stanford
California
Site 113
Torrance
California
Site 133
Vista
California
Site 161
Coral Gables
Florida
Site 114
Hialeah
Florida
Site 162
Miami Lakes
Florida
Site 159
Naples
Florida
Site 136
Atlanta
Georgia
Site 143
Boise
Idaho
Site 160
Chicago
Illinois
Site 154
Park Ridge
Illinois
Site 137
Fort Wayne
Indiana
Site 112
Indianapolis
Indiana
Site 104
Covington
Louisiana
Site 118
Baltimore
Maryland
Site 119
Boston
Massachusetts
Site 122
Bloomfield Hills
Michigan
Site 150
Farmington Hills
Michigan
Site 107
Rochester
Minnesota
Site 106
St Louis
Missouri
Site 105
St Louis
Missouri
Site 144
Brick
New Jersey
Site 153
Valhalla
New York
Site 152
Asheville
North Carolina
Site 109
Cary
North Carolina
Site 140
Charlotte
North Carolina
Site 145
Durham
North Carolina
Site 117
Cincinnati
Ohio
Site 100
Cleveland
Ohio
+ 22 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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