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The trial is taking place at:
L

Louisiana Heart Center | Covington, LA

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Study of JK07 in Patients With Chronic Heart Failure (RENEU-HF)

S

Salubris Biotherapeutics

Status and phase

Enrolling
Phase 2

Conditions

Heart Failure With Preserved Ejection Fraction
Heart Failure With Reduced Ejection Fraction

Treatments

Drug: JK07
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06369298
JK07.2.01

Details and patient eligibility

About

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%.

Participants in both cohorts will be randomized into either low dose JK07, high dose JK07 or placebo. Participants will have a 2:1 chance of receiving JK07 versus placebo.

Enrollment

282 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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 at least 3 consecutive readings.
  • 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 narrow complex 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 Atrial Fibrillation (AF) or atrial flutter, and a CHA2DS2-VASc score of ≥ 2 in men or ≥ 3 in women or per local guidelines, anticoagulation via non-vitamin K oral anticoagulants or warfarin is required. Percutaneous occlusion of the left atrial appendage alone is not adequate.
  • AF ablation within the last 12 weeks 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

282 participants in 3 patient groups, including a placebo group

JK07 low dose
Active Comparator group
Description:
JK07 administered by intravenous (IV) infusion
Treatment:
Drug: JK07
JK07 high dose
Active Comparator group
Description:
JK07 administered by intravenous (IV) infusion
Treatment:
Drug: JK07
Placebo
Placebo Comparator group
Description:
Placebo administered by intravenous (IV) infusion
Treatment:
Drug: Placebo

Trial contacts and locations

6

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Central trial contact

Amanda McEwen; Ashleigh Chasteen

Data sourced from clinicaltrials.gov

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