Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
282 participants
INTERVENTIONAL
2024-03-28
2026-06-30
Brief Summary
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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%.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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JK07 low dose
JK07 administered by intravenous (IV) infusion
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.
JK07 high dose
JK07 administered by intravenous (IV) infusion
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
Placebo administered by intravenous (IV) infusion
Placebo
0.9% sodium chloride
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Salubris Biotherapeutics Inc
INDUSTRY
Responsible Party
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Locations
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Site 117
Cincinnati, Ohio, United States
Site 100
Cleveland, Ohio, United States
Site 135
Oklahoma City, Oklahoma, United States
Site 101
Portland, Oregon, United States
Site 155
York, Pennsylvania, United States
Site 110
Dallas, Texas, United States
Site 115
Dallas, Texas, United States
Site 103
Houston, Texas, United States
Site 149
Tomball, Texas, United States
Site 148
Arlington, Virginia, United States
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
Site 160
Chicago, Illinois, United States
Site 154
Park Ridge, Illinois, United States
Site 137
Fort Wayne, Indiana, United States
Site 112
Indianapolis, Indiana, United States
Site 104
Covington, Louisiana, United States
Site 118
Baltimore, Maryland, United States
Site 119
Boston, Massachusetts, United States
Site 122
Bloomfield Hills, Michigan, United States
Site 150
Farmington Hills, Michigan, United States
Site 107
Rochester, Minnesota, United States
Site 106
St Louis, Missouri, United States
Site 105
St Louis, Missouri, United States
Site 144
Brick, New Jersey, United States
Site 153
Valhalla, New York, United States
Site 152
Asheville, North Carolina, United States
Site 109
Cary, North Carolina, United States
Site 140
Charlotte, North Carolina, United States
Site 145
Durham, North Carolina, United States
Site 123
Falls Church, Virginia, United States
Site 126
Norfolk, Virginia, United States
Site 163
Vienna, Virginia, United States
Site 202
Winnepeg, Manitoba, Canada
Site 203
Brampton, Ontario, Canada
Site 200
Chicoutimi, Quebec, Canada
Site 201
Trois-Rivières, Quebec, Canada
Site 305
Changsha, Hunan, China
Site 303
Nanjing, Jiangsu, China
Site 306
Jining, Shandong, China
Site 301
Chengdu, Sichuan, China
Site 300
Beijing, , China
Site 304
Chongqing, , China
Site 156
Ponce, , Puerto Rico
Countries
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Central Contacts
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Other Identifiers
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JK07.2.01
Identifier Type: -
Identifier Source: org_study_id
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