Active, not recruiting
Phase 2
Study of JK07 in Patients With Chronic Heart Failure
Condition(s) studied
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
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.
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