← Back to Search

Monoclonal Antibodies

IC14 for Arrhythmogenic Cardiomyopathy

Phase 1 & 2

Recruiting

Research Sponsored by Implicit Bioscience

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of ventricular tachycardia or ventricular fibrillation (VF) or ≥500 ventricular premature contractions (VPCs) in 24 hours on the most recent 24-hour Holter monitor recording

Age ≥ 18 years

Must not have

Receiving continuous infusion of antiarrhythmic medication at time of enrollment

Known severe renal or hepatic insufficiency as well as alanine transaminase (ALT)/aspartate transaminase (AST) elevations ≥ 3x upper limit normal (ULN)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks, and 14 weeks

Awards & highlights

Summary

This trial aims to test a new drug, IC14, in patients with a heart condition called arrhythmogenic cardiomyopathy who have an implantable defibrillator. The study will look at how

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects are not listed but generally could include reactions at the infusion site, changes in blood pressure or heartbeat, allergic reactions to the medication, or other unforeseen complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am 18 years old or older.

Select...

I have a heart condition with a specific genetic marker.

Select...

I am a woman not able to have children, in menopause, or will use two birth control methods after treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently on a continuous antiarrhythmic medication infusion.

Select...

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

Select...

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

Select...

I have not had major surgery in the last 6 weeks.

Select...

My doctor expects I have less than 1 year to live due to a non-heart related condition.

Select...

I am currently using or plan to use high-dose corticosteroids regularly.

Select...

I have had a heart attack before.

Select...

I have had an emergency procedure to correct my heart rhythm.

Select...

My heart failure is severe, limiting my ability to carry out physical activity.

Select...

I am on long-term immune system medications for arthritis.

Select...

I have no allergies to atibuclimab or similar drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks, and 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 weeks, and 14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, and 14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety: Incidence of anti-drug antibodies

Safety: Treatment-emergent adverse events and serious adverse events

Secondary study objectives

Atrial premature contractions

CCR2+ Myocardial Imaging (optional)

Disease biomarker N-terminal B-type natriuretic peptide (NT-pro-BNP)

+15 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: IC14 (atibuclimab)Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IC14

2017

Completed Phase 1

~10

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

Implicit BioscienceLead Sponsor

10 Previous Clinical Trials

125 Total Patients Enrolled

Jan Agosti, MDStudy DirectorImplicit Bioscience

3 Previous Clinical Trials

~2 spots leftby Feb 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.