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

April 16, 2024 updated by: Salubris Biotherapeutics Inc

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

282

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91105
        • Recruiting
        • Southern California Heart Specialists
        • Contact:
          • Gregory Giesler
    • Florida
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • New Generation of Medical Research
        • Contact:
          • Karelia Ruiz
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Louisiana Heart Center
        • Contact:
          • Bruce Iteld, MD
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48304
        • Recruiting
        • Cardiology and Vascular Associates
        • Contact:
          • Kirit Patel
    • Missouri
      • Saint Louis, Missouri, United States, 63136
        • Recruiting
        • St. Louis Heart and Vascular Cardiology
        • Contact:
          • Harvey Serota
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Southwest Family Medicine
        • Contact:
          • Chriistte Dharma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: JK07 low dose
JK07 administered by intravenous (IV) infusion
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.
Active Comparator: JK07 high dose
JK07 administered by intravenous (IV) infusion
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 Comparator: Placebo
Placebo administered by intravenous (IV) infusion
Drug: Placebo
0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salubris Biotherapeutics Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

April 12, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JK07.2.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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