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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
No Placebo-Only Group

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
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on a continuous antiarrhythmic medication infusion.
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My liver and kidney functions are normal, and my liver enzymes are not three times above the normal limit.
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I have not had major blood vessel surgery in the last 4 weeks.
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I have not had major surgery in the last 6 weeks.
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My doctor expects I have less than 1 year to live due to a non-heart related condition.
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I am currently using or plan to use high-dose corticosteroids regularly.
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I have had a heart attack before.
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I have had an emergency procedure to correct my heart rhythm.
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My heart failure is severe, limiting my ability to carry out physical activity.
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I am on long-term immune system medications for arthritis.
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I have no allergies to atibuclimab or similar drugs.

Timeline

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Implicit BioscienceLead Sponsor
11 Previous Clinical Trials
135 Total Patients Enrolled
Jan Agosti, MDStudy DirectorImplicit Bioscience
3 Previous Clinical Trials
~1 spots leftby Feb 2025
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