IC14 for Arrhythmogenic Cardiomyopathy

Recruiting at 1 trial location

Overseen By Sharon Heuerman, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Implicit Bioscience

Must not be taking: Antiarrhythmics, High-dose corticosteroids, DMARDS

Disqualifiers: Myocardial infarction, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

5 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not change your current medications for arrhythmogenic cardiomyopathy unless it's necessary for managing life-threatening conditions.

What is the purpose of this trial?

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.

Research Team

Jan Agosti, MD

Principal Investigator

Implicit Bioscience

Eligibility Criteria

This trial is for patients with arrhythmogenic cardiomyopathy (ACM), a heart muscle disease that can cause irregular heartbeats. Participants must have an implantable cardioverter/defibrillator (ICD) already in place.

Inclusion Criteria

C-reactive protein ≥1.5 mg/mL

I have had a serious irregular heartbeat or more than 500 early heartbeats in a day.

I am a male who hasn't had a vasectomy and will use contraception for 30 days after treatment.

Exclusion Criteria

I am currently on a continuous antiarrhythmic medication infusion.

My liver and kidney functions are normal, and my liver enzymes are not three times above the normal limit.

I have not had major blood vessel surgery in the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Testing

Participants undergo baseline testing including ECG, ECHO, and blood tests

1 week

1 visit (in-person)

Treatment

Participants receive 4 intravenous infusions of IC14 every 3 weeks, with blood measurements before and after each infusion

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including ECG, ECHO, and blood tests

2 weeks

2 visits (in-person)

Treatment Details

Interventions

• IC14

Trial Overview The trial tests IC14 (atibuclimab), focusing on its effects on inflammation markers, safety, and how the body processes it. It includes blood tests, heart scans, and monitoring of heart rhythms using existing ICDs and additional devices.

Participant Groups

Group I: IC14 (atibuclimab) Experimental Treatment 1 Intervention

IC14 (atibuclimab) 20 mg/kg intravenously every 3 weeks for 12 weeks (4 doses)

Who Is Running the Clinical Trial?

Implicit Bioscience

Lead Sponsor

Trials

12

Recruited

140+