Clinical trial NCT06369298: Study of JK07 in Patients With Chronic Heart Failure
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
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
Lead sponsor: Salubris Biotherapeutics Inc
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.


Eligibility criteria: 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 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.
* 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.

Primary outcomes:
measure: Safety - Cohort 1
timeFrame: Study entry through week 52
measure: Efficacy - Cohort 1
timeFrame: Baseline through week 26
measure: Safety - Cohort 2
timeFrame: Study entry through week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Alexander City
country: United States
facility: Site 121
state: Alabama
city: Birmingham
country: United States
facility: Site 130
state: Alabama
city: Birmingham
country: United States
facility: Site 139
state: Alabama
city: Huntsville
country: United States
facility: Site 138
state: Alabama
city: Phoenix
country: United States
facility: Site 111
state: Arizona
city: Little Rock
country: United States
facility: Site 127
state: Arkansas
city: Huntington Beach
country: United States
facility: Site 128
state: California
city: Orange
country: United States
facility: Site 158
state: California
city: Pasadena
country: United States
facility: Site 116
state: California
city: Santa Maria
country: United States
facility: Site 129
state: California
city: Stanford
country: United States
facility: Site 102
state: California
city: Torrance
country: United States
facility: Site 113
state: California
city: Vista
country: United States
facility: Site 133
state: California
city: Hialeah
country: United States
facility: Site 114
state: Florida
city: Naples
country: United States
facility: Site 159
state: Florida
city: Atlanta
country: United States
facility: Site 136
state: Georgia
city: Boise
country: United States
facility: Site 143
state: Idaho
city: Chicago
country: United States
facility: Site 160
state: Illinois
city: Park Ridge
country: United States
facility: Site 154
state: Illinois
city: Fort Wayne
country: United States
facility: Site 137
state: Indiana
city: Indianapolis
country: United States
facility: Site 112
state: Indiana
city: Covington
country: United States
facility: Site 104
state: Louisiana
city: Boston
country: United States
facility: Site 119
state: Massachusetts
city: Bloomfield Hills
country: United States
facility: Site 122
state: Michigan
city: Farmington Hills
country: United States
facility: Site 150
state: Michigan
city: Rochester
country: United States
facility: Site 107
state: Minnesota
city: Saint Louis
country: United States
facility: Site 106
state: Missouri
city: Saint Louis
country: United States
facility: Site 105
state: Missouri
city: Brick
country: United States
facility: Site 144
state: New Jersey
city: Valhalla
country: United States
facility: Site 153
state: New York
city: Asheville
country: United States
facility: Site 152
state: North Carolina
city: Cary
country: United States
facility: Site 109
state: North Carolina
city: Charlotte
country: United States
facility: Site 140
state: North Carolina
city: Cincinnati
country: United States
facility: Site 117
state: Ohio
city: Cleveland
country: United States
facility: Site 100
state: Ohio
city: Oklahoma City
country: United States
facility: Site 135
state: Oklahoma
city: York
country: United States
facility: Site 155
state: Pennsylvania
city: Dallas
country: United States
facility: Site 110
state: Texas
city: Dallas
country: United States
facility: Site 115
state: Texas
city: Houston
country: United States
facility: Site 103
state: Texas
city: Tomball
country: United States
facility: Site 149
state: Texas
city: Arlington
country: United States
facility: Site 148
state: Virginia
city: Falls Church
country: United States
facility: Site 123
state: Virginia
city: Norfolk
country: United States
facility: Site 126
state: Virginia
city: Winnepeg
country: Canada
facility: Site 202
state: Manitoba
city: Brampton
country: Canada
facility: Site 203
state: Ontario
city: Chicoutimi
country: Canada
facility: Site 200
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Site 201
state: Quebec
city: Changsha
country: China
facility: Site 305
state: Hunan
city: Nanjing
country: China
facility: Site 303
state: Jiangsu
city: Jining
country: China
facility: Site 306
state: Shandong
city: Chengdu
country: China
facility: Site 301
state: Sichuan
city: Beijing
country: China
facility: Site 300
city: Chongqing
country: China
facility: Site 304
city: Ponce
country: Puerto Rico
facility: Site 156
Study officials:
References: