IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy (NCT06275893) | Clinical Trial Compass
CompletedPhase 1/2
IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy
United States1 participantsStarted 2024-03-29
Plain-language summary
The goal of this clinical trial is to test IC14 (atibuclimab) in patients with arrhythmogenic cardiomyopathy (ACM) and who have an implantable cardoverter/defibrillator in place. ACM is also called arrhythmogenic right ventricular dysplasia (ARV) or arrhythmogenic right ventricular cardiomyopathy (ARVC). The main questions the study aims to answer are the effect of treatment on blood markers of inflammation, safety, and pharmacokinetics. There will also be measurements of myocardial imaging of C-C chemokine receptor type 2 (CCR2+) immune cells (optional), monitoring of cardiac arrhythmias using the patient's pre-existing intracardiac cardioverter/defibrillator (ICD) and a Holter monitor, electrocardiogram (ECG), echocardiogram (ECHO), and blood tests. Results will be compared to baseline; there is no inactive placebo treatment group.
Participants will be asked to undergo screening and baseline testing, then receive 4 intravenous infusions with blood measurements before and after the infusion (including 24, 48, and 72 hours and 7, 14, and 28 days). Participants will be offered specialized scanning of the heart muscle, and will be asked to provide recordings from their ICD, undergo Holter monitoring twice, and have electrocardiograms (ECG), echocardiograms (ECHO) and blood tests.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years
✓. Diagnosis of arrhythmogenic cardiomyopathy and: 1) meeting the 2020 Modified Task Force Criteria as affected;
✓. Left ventricular ejection fraction of ≥30%
✓. Functioning implantable cardioverter/defibrillator with remote interrogation capability
✓. One of the following: 1) a history of ventricular tachycardia or ventricular fibrillation (VF); 2) ≥500 ventricular premature contractions (VPCs) in 24 hours on the most recent 24-hour Holter monitor recording; or 3) C-reactive protein \>=1.5 mg/mL
✓. Agreement by subject, physician, and cardiologist to not change concomitant ACM medications or to conduct catheter ablation during study participation unless needed for management of life-threatening conditions
✓. Capable and willing to provide informed consent
✓. Capable of completing study visits
Exclusion criteria
✕
What they're measuring
1
Safety: Treatment-emergent adverse events and serious adverse events
✕. Receiving continuous infusion of antiarrhythmic medication at time of enrollment
✕. Previous major vascular intervention within 4 weeks
✕. NYHA heart failure class IV, except palpitations
✕. Major surgery within 6 weeks
✕. Patient has participated in any study using an investigational drug or device within 30 days
✕. Life expectancy of less than 1 year due to non-cardiac pathology
✕. History of allergic reaction to atibuclimab (IC14) or any monoclonal antibody drug product or other CD14-derived drug product or any component used in the study (including contrast media)