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IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy

NCT06275893 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Arrhythmogenic Right Ventricular Dysplasia
  • Arrhythmogenic Left Ventricular Cardiomyopathy
  • Arrhythmogenic Right Ventricular Cardiomyopathy 1
  • Arrhythmogenic Cardiomyopathy
  • ACM
  • ARVC
  • PKP2

Interventions

BIOLOGICAL

IC14

recombinant monoclonal antibody directed against cluster of differentiation 14 (CD14) antigen

Sponsors & Collaborators

  • Implicit Bioscience

    lead INDUSTRY

Principal Investigators

  • Jan Agosti, MD · Implicit Bioscience

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-29
Primary Completion
2025-08-15
Completion
2026-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06275893 on ClinicalTrials.gov