RecruitingPhase 2NCT06369298

Study of JK07 in Patients With Chronic Heart Failure

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)

Sponsor

Salubris Biotherapeutics Inc

Enrollment

282 participants

Start Date

Mar 28, 2024

Study Type

INTERVENTIONAL

Conditions

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

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%.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called JK07 in people with chronic heart failure to see if it is safe and effective at improving heart function. **You may be eligible if...** - You have been diagnosed with heart failure classified as NYHA Class II or III (meaning you have symptoms with moderate or minimal activity) - Cohort 1: Your heart's pumping function is significantly reduced (ejection fraction ≤ 40%) - Cohort 2: Your heart's pumping function is mildly reduced (ejection fraction 40–65%), your BNP level is elevated (≥600 pg/mL), and you have atrial fibrillation or flutter - Your heart failure is stable and you are on optimal medical therapy **You may NOT be eligible if...** - You have had a recent heart attack or hospitalization for heart failure - You have significant heart valve disease or uncontrolled arrhythmias - You are pregnant or breastfeeding - You have severe kidney or liver dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJK07

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.

DRUGPlacebo

0.9% sodium chloride

Locations(62)

Site 121

Alexander City, Alabama, United States

Site 130

Birmingham, Alabama, United States

Site 139

Birmingham, Alabama, United States

Site 138

Huntsville, Alabama, United States

Site 111

Phoenix, Arizona, United States

Site 127

Little Rock, Arkansas, United States

Site 128

Huntington Beach, California, United States

Site 157

Los Angeles, California, United States

Site 158

Orange, California, United States

Site 116

Pasadena, California, United States

Site 129

Santa Maria, California, United States

Site 102

Stanford, California, United States

Site 113

Torrance, California, United States

Site 133

Vista, California, United States

Site 161

Coral Gables, Florida, United States

Site 114

Hialeah, Florida, United States

Site 162

Miami Lakes, Florida, United States

Site 159

Naples, Florida, United States

Site 136

Atlanta, Georgia, United States

Site 143

Boise, Idaho, United States

Site 160

Chicago, Illinois, United States

Site 154

Park Ridge, Illinois, United States

Site 137

Fort Wayne, Indiana, United States

Site 112

Indianapolis, Indiana, United States

Site 104

Covington, Louisiana, United States

Site 118

Baltimore, Maryland, United States

Site 119

Boston, Massachusetts, United States

Site 122

Bloomfield Hills, Michigan, United States

Site 150

Farmington Hills, Michigan, United States

Site 107

Rochester, Minnesota, United States

Site 106

St Louis, Missouri, United States

Site 105

St Louis, Missouri, United States

Site 144

Brick, New Jersey, United States

Site 153

Valhalla, New York, United States

Site 152

Asheville, North Carolina, United States

Site 109

Cary, North Carolina, United States

Site 140

Charlotte, North Carolina, United States

Site 145

Durham, North Carolina, United States

Site 117

Cincinnati, Ohio, United States

Site 100

Cleveland, Ohio, United States

Site 135

Oklahoma City, Oklahoma, United States

Site 101

Portland, Oregon, United States

Site 155

York, Pennsylvania, United States

Site 110

Dallas, Texas, United States

Site 115

Dallas, Texas, United States

Site 103

Houston, Texas, United States

Site 149

Tomball, Texas, United States

Site 148

Arlington, Virginia, United States

Site 123

Falls Church, Virginia, United States

Site 126

Norfolk, Virginia, United States

Site 163

Vienna, Virginia, United States

Site 202

Winnepeg, Manitoba, Canada

Site 203

Brampton, Ontario, Canada

Site 200

Chicoutimi, Quebec, Canada

Site 201

Trois-Rivières, Quebec, Canada

Site 305

Changsha, Hunan, China

Site 303

Nanjing, Jiangsu, China

Site 306

Jining, Shandong, China

Site 301

Chengdu, Sichuan, China

Site 300

Beijing, China

Site 304

Chongqing, China

Site 156

Ponce, Puerto Rico

View Full Details on ClinicalTrials.gov

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NCT06369298

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