TrialPath
← Back to searchRecruiting

Study of JK07 in Patients With Chronic Heart Failure

NCT06369298 · Salubris Biotherapeutics Inc
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
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)
About this study
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 criteria
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.
Study design
Enrollment target: 282 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2024-03-28
Estimated completion: 2026-06-30
Last updated: 2025-08-22
Interventions
Drug: JK07Drug: Placebo
Primary outcomes
  • Safety - Cohort 1 (Study entry through week 52)
  • Efficacy - Cohort 1 (Baseline through week 26)
  • Safety - Cohort 2 (Study entry through week 52)
Sponsor
Salubris Biotherapeutics Inc · industry
Contacts & investigators
ContactAmanda McEwen · contact · Info@SalubrisBio.com · 888-521-8961
ContactAshleigh Chasteen · contact · Info@Salubrisbio.com · 888-521-8961
All locations (62)
Site 121Recruiting
Alexander City, Alabama, United States
Site 130Recruiting
Birmingham, Alabama, United States
Site 139Recruiting
Birmingham, Alabama, United States
Site 138Recruiting
Huntsville, Alabama, United States
Site 111Recruiting
Phoenix, Arizona, United States
Site 127Recruiting
Little Rock, Arkansas, United States
Site 128Recruiting
Huntington Beach, California, United States
Site 157Recruiting
Los Angeles, California, United States
Site 158Recruiting
Orange, California, United States
Site 116Recruiting
Pasadena, California, United States
Site 129Recruiting
Santa Maria, California, United States
Site 102Recruiting
Stanford, California, United States
Site 113Recruiting
Torrance, California, United States
Site 133Recruiting
Vista, California, United States
Site 161Recruiting
Coral Gables, Florida, United States
Site 114Recruiting
Hialeah, Florida, United States
Site 162Recruiting
Miami Lakes, Florida, United States
Site 159Recruiting
Naples, Florida, United States
Site 136Recruiting
Atlanta, Georgia, United States
Site 143Recruiting
Boise, Idaho, United States
Site 160Recruiting
Chicago, Illinois, United States
Site 154Recruiting
Park Ridge, Illinois, United States
Site 137Recruiting
Fort Wayne, Indiana, United States
Site 112Recruiting
Indianapolis, Indiana, United States
Site 104Recruiting
Covington, Louisiana, United States
Site 118Recruiting
Baltimore, Maryland, United States
Site 119Recruiting
Boston, Massachusetts, United States
Site 122Recruiting
Bloomfield Hills, Michigan, United States
Site 150Recruiting
Farmington Hills, Michigan, United States
Site 107Recruiting
Rochester, Minnesota, United States
Site 106Recruiting
St Louis, Missouri, United States
Site 105Recruiting
St Louis, Missouri, United States
Site 144Recruiting
Brick, New Jersey, United States
Site 153Recruiting
Valhalla, New York, United States
Site 152Recruiting
Asheville, North Carolina, United States
Site 109Recruiting
Cary, North Carolina, United States
Site 140Recruiting
Charlotte, North Carolina, United States
Site 145Recruiting
Durham, North Carolina, United States
Site 117Recruiting
Cincinnati, Ohio, United States
Site 100Recruiting
Cleveland, Ohio, United States
Site 135Recruiting
Oklahoma City, Oklahoma, United States
Site 101Recruiting
Portland, Oregon, United States
Site 155Recruiting
York, Pennsylvania, United States
Site 110Recruiting
Dallas, Texas, United States
Site 115Recruiting
Dallas, Texas, United States
Site 103Recruiting
Houston, Texas, United States
Site 149Recruiting
Tomball, Texas, United States
Site 148Recruiting
Arlington, Virginia, United States
Site 123Recruiting
Falls Church, Virginia, United States
Site 126Recruiting
Norfolk, Virginia, United States
Site 163Recruiting
Vienna, Virginia, United States
Site 202Recruiting
Winnepeg, Manitoba, Canada
Site 203Recruiting
Brampton, Ontario, Canada
Site 200Recruiting
Chicoutimi, Quebec, Canada
Site 201Recruiting
Trois-Rivières, Quebec, Canada
Site 305Recruiting
Changsha, Hunan, China
Site 303Recruiting
Nanjing, Jiangsu, China
Site 306Recruiting
Jining, Shandong, China
Site 301Recruiting
Chengdu, Sichuan, China
Site 300Recruiting
Beijing, China
Site 304Recruiting
Chongqing, China
Site 156Recruiting
Ponce, Puerto Rico
Study of JK07 in Patients With Chronic Heart Failure · TrialPath