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Monoclonal Antibodies

IC14 (atibuclimab) for Right Ventricular 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks, and 14 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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

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I am 18 years old or older.

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I have a heart condition with a specific genetic marker.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety: Incidence of anti-drug antibodies

Safety: Treatment-emergent adverse events and serious adverse events

Secondary outcome measures

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Implicit BioscienceLead Sponsor

8 Previous Clinical Trials

59 Total Patients Enrolled

Jan Agosti, MDStudy DirectorImplicit Bioscience

3 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this research study still ongoing?

"Information from clinicaltrials.gov indicates that at the current moment, this specific research study is not in active recruitment. Although initially posted on February 19th, 2024 and updated most recently on February 16th, 2024, it is important to note that while this trial isn’t enrolling participants presently, there are a total of 185 other trials actively seeking candidates for participation."

Answered by AI

What are the main goals being pursued in this research endeavor?

"Throughout the period spanning from Baseline to 14 weeks, the primary focus of this study is on evaluating Safety by tracking the occurrence of anti-drug antibodies. Secondary aims involve examining Pharmacokinetics through assessing Serum IC14 concentration over time using Area under the curve (AUC), investigating Pharmacodynamics via measuring monocyte membrane CD14 receptor occupancy known as Receptor Occupancy, and analyzing Peak serum IC14 concentration for Pharmacokinetics purposes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy

2024. "IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06275893.

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