Study of JK07 in Patients With Chronic Heart Failure
- Conditions
- Heart Failure With Reduced Ejection FractionHeart Failure With Preserved Ejection Fraction
- Interventions
- Drug: Placebo
- Registration Number
- NCT06369298
- Lead Sponsor
- Salubris Biotherapeutics Inc
- 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%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 282
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JK07 low dose JK07 JK07 administered by intravenous (IV) infusion Placebo Placebo Placebo administered by intravenous (IV) infusion JK07 high dose JK07 JK07 administered by intravenous (IV) infusion
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (55)
Site 138
🇺🇸Huntsville, Alabama, United States
Site 127
🇺🇸Little Rock, Arkansas, United States
Site 158
🇺🇸Orange, California, United States
Site 121
🇺🇸Alexander City, Alabama, United States
Site 130
🇺🇸Birmingham, Alabama, United States
Site 143
🇺🇸Boise, Idaho, United States
Site 154
🇺🇸Park Ridge, Illinois, United States
Site 119
🇺🇸Boston, Massachusetts, United States
Site 150
🇺🇸Farmington Hills, Michigan, United States
Site 144
🇺🇸Brick, New Jersey, United States
Site 153
🇺🇸Valhalla, New York, United States
Site 109
🇺🇸Cary, North Carolina, United States
Site 103
🇺🇸Houston, Texas, United States
Site 304
🇨🇳Chongqing, China
Site 128
🇺🇸Huntington Beach, California, United States
Site 140
🇺🇸Charlotte, North Carolina, United States
Site 117
🇺🇸Cincinnati, Ohio, United States
Site 135
🇺🇸Oklahoma City, Oklahoma, United States
Site 115
🇺🇸Dallas, Texas, United States
Site 148
🇺🇸Arlington, Virginia, United States
Site 202
🇨🇦Winnepeg, Manitoba, Canada
Site 203
🇨🇦Brampton, Ontario, Canada
Site 139
🇺🇸Birmingham, Alabama, United States
Site 111
🇺🇸Phoenix, Arizona, United States
Site 116
🇺🇸Pasadena, California, United States
Site 102
🇺🇸Stanford, California, United States
Site 114
🇺🇸Hialeah, Florida, United States
Site 159
🇺🇸Naples, Florida, United States
Site 137
🇺🇸Fort Wayne, Indiana, United States
Site 112
🇺🇸Indianapolis, Indiana, United States
Site 104
🇺🇸Covington, Louisiana, United States
Site 106
🇺🇸Saint Louis, Missouri, United States
Site 105
🇺🇸Saint Louis, Missouri, United States
Site 100
🇺🇸Cleveland, Ohio, United States
Site 149
🇺🇸Tomball, Texas, United States
Site 201
🇨🇦Trois-Rivieres, Quebec, Canada
Site 305
🇨🇳Changsha, Hunan, China
Site 306
🇨🇳Jining, Shandong, China
Site 129
🇺🇸Santa Maria, California, United States
Site 123
🇺🇸Falls Church, Virginia, United States
Site 303
🇨🇳Nanjing, Jiangsu, China
Site 301
🇨🇳Chengdu, Sichuan, China
Site 300
🇨🇳Beijing, China
Site 156
🇵🇷Ponce, Puerto Rico
Site 113
🇺🇸Torrance, California, United States
Site 133
🇺🇸Vista, California, United States
Site 136
🇺🇸Atlanta, Georgia, United States
Site 160
🇺🇸Chicago, Illinois, United States
Site 122
🇺🇸Bloomfield Hills, Michigan, United States
Site 107
🇺🇸Rochester, Minnesota, United States
Site 152
🇺🇸Asheville, North Carolina, United States
Site 155
🇺🇸York, Pennsylvania, United States
Site 110
🇺🇸Dallas, Texas, United States
Site 126
🇺🇸Norfolk, Virginia, United States
Site 200
🇨🇦Chicoutimi, Quebec, Canada