Study of JK07 in Patients With Chronic Heart Failure

Heart Failure With Preserved Ejection Fraction Clinical Trial

— RENEU-HF  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06369298
• Other study ID #: JK07.2.01
• Status: Recruiting
• Phase: Phase 2
• Start date: March 28, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Salubris Biotherapeutics Inc
• Contact: Amanda McEwen
• Phone: 617-584-3853
• Email: Info[@]SalubrisBio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 282
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

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 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Cardiology and Vascular Associates	Bloomfield Hills	Michigan
United States	Louisiana Heart Center	Covington	Louisiana
United States	Southwest Family Medicine	Dallas	Texas
United States	New Generation of Medical Research	Hialeah	Florida
United States	Southern California Heart Specialists	Pasadena	California
United States	St. Louis Heart and Vascular Cardiology	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Salubris Biotherapeutics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Cohort 1	Incidence and severity of treatment emergent adverse events	Study entry through week 52
Primary	Efficacy - Cohort 1	Change in LVEF measured by 2D-TTE	Baseline through week 26
Primary	Safety - Cohort 2	Incidence and severity of treatment emergent adverse events	Study entry through week 52