A Phase 1/2 interventional study of IC14 in Arrhythmogenic Right Ventricular Dysplasia, Arrhythmogenic Left Ventricular Cardiomyopathy and Arrhythmogenic Right Ventricular Cardiomyopathy 1, sponsored by Implicit Bioscience. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Implicit Bioscience · Phase 1/2, Interventional, and Treatment
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.
This proof-of-concept study will evaluate the safety, pharmacokinetics, and preliminary efficacy of IC14 administered via IV infusion in patients with ACM.
In preclinical studies, anti-CD14 treatment prevented the development of ventricular dysfunction and cardiac damage in a mouse model of arrhythmogenic cardiomyopathy.
The objective of this study is to determine whether IC14 treatment reduces markers of inflammation and disease biomarkers in ACM patients treated with IC14. Secondary objectives are to further characterize the effect of IC14 treatment on CCR2+ cell myocardial infiltration measured by myocardial positron emission tomography (PET)/CT imaging, ventricular premature contractions (VPCs), other arrhythmias, ICD discharges, NYHA functional classification, and quality of life.
To characterize safety of IC14, the following assessments are to be performed: clinical biochemistry (safety analyses), ECG, ECHO, adverse events (AEs), serious adverse events (SAEs), and formation of anti-drug antibodies.
Finally, pharmacokinetic/pharmacodynamic parameters will be conducted. These include blood test measurements levels of the drug and its binding to its target in the serum and on cells.
This study will assign 5 patients to intravenous (IV) administration of IC14 (atibulcimab) at 20 mg/kg. The study drug will be administered every three weeks via IV infusion, for a total of 4 infusions (12 weeks of treatment).
47 studies on the registry are indexed under Arrhythmogenic Right Ventricular Dysplasia; 24 are open to participants now.
This study's enrollment of 1 is below the median of 34 across 15 interventional studies indexed under Arrhythmogenic Right Ventricular Dysplasia.
Browse Arrhythmogenic Right Ventricular Dysplasia studies →Implicit Bioscience is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients are eligible for the study if all of the following criteria are met:
Females participating in the study must meet one of the following criteria:
Exclusion Criteria:
A patient fulfilling any of the following criteria is to be excluded from enrollment in the study:
IC14 (atibuclimab) 20 mg/kg intravenously every 3 weeks for 12 weeks (4 doses)
Biological: IC14
recombinant monoclonal antibody directed against cluster of differentiation 14 (CD14) antigen
Also known as: (atibuclimab)
Safety: Treatment-emergent adverse events and serious adverse events
Treatment-emergent adverse events and serious adverse events
Time frame: Baseline through 14 weeks
Safety: Incidence of anti-drug antibodies
Incidence of anti-drug antibodies
Time frame: Baseline, 4 weeks, and 14 weeks
Inflammatory biomarker C-reactive protein
Change in concentration from baseline at 12 weeks
Time frame: Baseline, 12 weeks
CCR2+ Myocardial Imaging (optional)
Mean change in CCR2+ cell myocardial infiltration measured by CCR2+ PET/CT imaging (standardized uptake value)
Time frame: Baseline compared to 12 weeks
Ventricular tachycardia
Number of ventricular tachycardia runs in a 7-day Holter monitor
Time frame: Baseline compared to 12 weeks
Ventricular premature contractions
Frequency of ventricular premature contractions in a 7-day Holter monitor
Time frame: Baseline compared to 12 weeks
Sustained and non-sustained ventricular tachycardia
Number of episodes of sustained and non-sustained ventricular tachycardia documented by ICD
Time frame: Baseline through 12 weeks
Treated ventricular tachycardia
Number of episodes of treated ventricular tachycardia (pacemaker and/or defibrillation) by ICD
Time frame: Baseline through 12 weeks
Atrial premature contractions
Number of atrial premature contractions in a 7-day Holter monitor
Time frame: Baseline compared to 12 weeks
New York Heart Association (NYHA) Functional Class
Change in NYHA Functional Class Questionnaire
Time frame: Baseline compared to 12 weeks
Implantable cardioverter/defibrillator (ICD) discharges
Frequency of ICD discharges (appropriate and/or inappropriate)
Time frame: Baseline through 12 weeks
Quality-of-Life Score determined by the Kansas City Cardiomyopathy Questionnaire
Change in Quality-of-Life Score determined by the Kansas City Cardiomyopathy Questionnaire, range 0 (very poor) to 65 (excellent)
Time frame: Baseline compared to 12 weeks
Disease biomarker Troponin I
Change in concentration from baseline at 12 weeks
Time frame: Baseline, 12 weeks
Disease biomarker N-terminal B-type natriuretic peptide (NT-pro-BNP)
Change in concentration from baseline at 12 weeks
Time frame: Baseline, 12 weeks
Inflammatory biomarker interleukin (IL)1-beta
Change in concentration from baseline at 12 weeks
Time frame: Baseline, 12 weeks
Pharmacokinetics: Serum IC14 concentration versus time curve
Area under the serum concentration versus time curve (AUC)
Time frame: Baseline through 14 weeks
Pharmacokinetics: Peak serum IC14 concentration
Peak serum IC14 concentration
Time frame: Baseline through 14 weeks
Pharmacokinetics: Half life
Half-life of serum IC14 concentration
Time frame: Baseline through 14 weeks
Pharmacodynamics: Receptor Occupancy
Measurement of monocyte membrane CD14 receptor occupancy
Time frame: Baseline through 14 weeks
Pharmacodynamics: Effective Concentration 95%
Estimation of serum concentration of IC14 to achieve 95% monocyte membrane receptor occupancy
Time frame: Baseline through 14 weeks
Plan to share: No
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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