protocolSection identificationModule nctId: NCT06275893, orgStudyIdInfo id: ACM01, briefTitle: IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Implicit Bioscience, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Arrhythmogenic Right Ventricular Dysplasia, conditions: Arrhythmogenic Left Ventricular Cardiomyopathy, conditions: Arrhythmogenic Right Ventricular Cardiomyopathy 1, conditions: Arrhythmogenic Cardiomyopathy, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open-label treatment with IC14. Participant outcomes will be compared to baseline. Pharmacokinetics will be measured., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: IC14, outcomesModule primaryOutcomes measure: Safety: Treatment-emergent adverse events and serious adverse events, primaryOutcomes measure: Safety: Incidence of anti-drug antibodies, secondaryOutcomes measure: Inflammatory biomarker C-reactive protein, secondaryOutcomes measure: CCR2+ Myocardial Imaging (optional), secondaryOutcomes measure: Ventricular tachycardia, secondaryOutcomes measure: Ventricular premature contractions, secondaryOutcomes measure: Sustained and non-sustained ventricular tachycardia, secondaryOutcomes measure: Treated ventricular tachycardia, secondaryOutcomes measure: Atrial premature contractions, secondaryOutcomes measure: New York Heart Association (NYHA) Functional Class, secondaryOutcomes measure: Implantable cardioverter/defibrillator (ICD) discharges, secondaryOutcomes measure: Quality-of-Life Score determined by the Kansas City Cardiomyopathy Questionnaire, secondaryOutcomes measure: Disease biomarker Troponin I, secondaryOutcomes measure: Disease biomarker N-terminal B-type natriuretic peptide (NT-pro-BNP), secondaryOutcomes measure: Inflammatory biomarker interleukin (IL)1-beta, secondaryOutcomes measure: Pharmacokinetics: Serum IC14 concentration versus time curve, secondaryOutcomes measure: Pharmacokinetics: Peak serum IC14 concentration, secondaryOutcomes measure: Pharmacokinetics: Half life, secondaryOutcomes measure: Pharmacodynamics: Receptor Occupancy, secondaryOutcomes measure: Pharmacodynamics: Effective Concentration 95%, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Washington University School of Medicine, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Philip S. Cuculich, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, hasResults: False