Study of JK07 in Patients With Chronic Heart Failure

NCT06369298 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: JK07.2.01
• Study Type: interventional
• Target: 282
• Locations: 4 countries
• Sites: 62

Brief 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%.

Conditions

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

Keywords

Heart Failure; Heart Failure with Reduced Ejection Fraction; Heart Failure with Preserved Ejection Fraction; Heart Failure NYHA Class III; Heart Failure NYHA Class II; Heart Failure with Atrial Fibrillation/Flutter; HFrEF; HFpEF; Neuregulin 1; NRG-1; HER3; HER4; ErbB3; ErbB4; Systolic Heart Failure; Diastolic Heart Failure; Atrial Fibrillation; Atrial Flutter

Outcome Measures

Primary Outcomes (3)

• Safety - Cohort 1

  Incidence and severity of treatment emergent adverse events

  Study entry through week 52

• Efficacy - Cohort 1

  Change in LVEF measured by 2D-TTE

  Baseline through week 26

• Safety - Cohort 2

  Incidence and severity of treatment emergent adverse events

  Study entry through week 52

Study Arms (3)

JK07 low dose

ACTIVE COMPARATOR

JK07 administered by intravenous (IV) infusion

Drug: JK07

JK07 high dose

ACTIVE COMPARATOR

JK07 administered by intravenous (IV) infusion

Drug: JK07

Placebo

PLACEBO COMPARATOR

Placebo administered by intravenous (IV) infusion

Drug: Placebo

Interventions

JK07 DRUG

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 low dose

Placebo DRUG

0.9% sodium chloride

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Salubris Biotherapeutics Inc: lead

Study Sites (62)

Site 121

Alexander City, Alabama, 35010, United States

Location

Site 130

Birmingham, Alabama, 35211, United States

Location

Site 139

Birmingham, Alabama, 35294, United States

Location

Site 138

Huntsville, Alabama, 35801, United States

Location

Site 111

Phoenix, Arizona, 85016, United States

Location

Site 127

Little Rock, Arkansas, 72205, United States

Location

Site 128

Huntington Beach, California, 92648, United States

Location

Site 157

Los Angeles, California, 90033, United States

Location

Site 158

Orange, California, 92868, United States

Location

Site 116

Pasadena, California, 91105, United States

Location

Site 129

Santa Maria, California, 93454, United States

Location

Site 102

Stanford, California, 94305, United States

Location

Site 113

Torrance, California, 90502, United States

Location

Site 133

Vista, California, 92081, United States

Location

Site 161

Coral Gables, Florida, 33134, United States

Location

Site 114

Hialeah, Florida, 33016, United States

Location

Site 162

Miami Lakes, Florida, 33014, United States

Location

Site 159

Naples, Florida, 34104, United States

Location

Site 136

Atlanta, Georgia, 30343, United States

Location

Site 143

Boise, Idaho, 83712, United States

Location

Site 160

Chicago, Illinois, 60611, United States

Location

Site 154

Park Ridge, Illinois, 60068, United States

Location

Site 137

Fort Wayne, Indiana, 46804, United States

Location

Site 112

Indianapolis, Indiana, 46250, United States

Location

Site 104

Covington, Louisiana, 70433, United States

Location

Site 118

Baltimore, Maryland, 21201, United States

Location

Site 119

Boston, Massachusetts, 02114, United States

Location

Site 122

Bloomfield Hills, Michigan, 48304, United States

Location

Site 150

Farmington Hills, Michigan, 48334, United States

Location

Site 107

Rochester, Minnesota, 55905, United States

Location

Site 106

St Louis, Missouri, 63110, United States

Location

Site 105

St Louis, Missouri, 63136, United States

Location

Site 144

Brick, New Jersey, 08724, United States

Location

Site 153

Valhalla, New York, 10595, United States

Location

Site 152

Asheville, North Carolina, 28803, United States

Location

Site 109

Cary, North Carolina, 27518, United States

Location

Site 140

Charlotte, North Carolina, 28204, United States

Location

Site 145

Durham, North Carolina, 27710, United States

Location

Site 117

Cincinnati, Ohio, 45219, United States

Location

Site 100

Cleveland, Ohio, 44195, United States

Location

Site 135

Oklahoma City, Oklahoma, 73135, United States

Location

Site 101

Portland, Oregon, 97239, United States

Location

Site 155

York, Pennsylvania, 17403, United States

Location

Site 110

Dallas, Texas, 75235, United States

Location

Site 115

Dallas, Texas, 75246, United States

Location

Site 103

Houston, Texas, 77030, United States

Location

Site 149

Tomball, Texas, 77375, United States

Location

Site 148

Arlington, Virginia, 22205, United States

Location

Site 123

Falls Church, Virginia, 22042, United States

Location

Site 126

Norfolk, Virginia, 23507, United States

Location

Site 163

Vienna, Virginia, 22182, United States

Location

Site 202

Winnepeg, Manitoba, R2H2A6, Canada

Location

Site 203

Brampton, Ontario, L6Z 4N5, Canada

Location

Site 200

Chicoutimi, Quebec, G7H 7K9, Canada

Location

Site 201

Trois-Rivières, Quebec, G9A 4P3, Canada

Location

Site 305

Changsha, Hunan, 410005, China

Location

Site 303

Nanjing, Jiangsu, 210009, China

Location

Site 306

Jining, Shandong, 272100, China

Location

Site 301

Chengdu, Sichuan, 610041, China

Location

Site 300

Beijing, 100037, China

Location

Site 304

Chongqing, 404000, China

Location

Site 156

Ponce, 00717, Puerto Rico

Location

MeSH Terms

Conditions

Heart Failure; Fibromatosis, Gingival, 2; Heart Failure, Systolic; Heart Failure, Diastolic; Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 16, 2024
• Study Start: March 28, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (51); CN (6); CA (4); PR (1)