IC14 for Arrhythmogenic Cardiomyopathy

Not currently recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an experimental treatment called IC14 for individuals with arrhythmogenic cardiomyopathy, a condition where the heart muscle thickens and becomes prone to dangerous rhythms, who also have an implantable cardioverter/defibrillator (ICD). Researchers aim to determine if IC14 can reduce blood inflammation, while also assessing its safety and how it moves through the body. Those with frequent abnormal heart rhythms or a certain level of inflammation, measured by C-reactive protein, might be suitable candidates. Participants will receive four infusions of the treatment, with close monitoring of their heart and blood. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that IC14 is likely to be safe for humans?

Research has shown that IC14, also known as atibuclimab, has been tested for safety in various situations. In studies with patients who had severe COVID-19, IC14 was generally well-tolerated. Some participants experienced side effects, mostly mild to moderate, suggesting that IC14 is relatively safe for humans.

IC14 is an antibody, a type of protein that helps the body fight certain diseases. This antibody specifically targets a molecule called CD14. Testing so far has not revealed any major safety concerns.

While these studies provide some reassurance, each new trial aims to gather more detailed safety information. Since this trial is in an early phase, it focuses on closely monitoring patient responses to IC14, including any side effects and how the body processes the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for arrhythmogenic cardiomyopathy?

Researchers are excited about IC14 (atibuclimab) for arrhythmogenic cardiomyopathy because it offers a fresh approach compared to existing treatments. Most current therapies focus on managing symptoms and preventing arrhythmias, but IC14 acts differently by targeting the immune system. It uses a monoclonal antibody that could help modulate immune responses, potentially addressing the underlying causes of the condition rather than just the symptoms. This new mechanism of action is what makes IC14 stand out and holds promise for more effective management of the disease.

What evidence suggests that IC14 might be an effective treatment for arrhythmogenic cardiomyopathy?

Research has shown that IC14 (atibuclimab), the investigational treatment in this trial, might help people with arrhythmogenic cardiomyopathy (ACM) by reducing inflammation. This treatment targets CD14, a protein involved in the body's immune response, potentially managing the inflammation linked to ACM. Early results suggest that IC14 can lower inflammation markers, which are often elevated in people with ACM and can worsen heart problems. Although information on its effectiveness in humans remains limited, the treatment is under study for its potential to improve heart health by reducing these harmful inflammatory responses. ^{1 4 6 7 8}

Who Is on the Research Team?

Jan Agosti, MD

Principal Investigator

Implicit Bioscience

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/426537?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy - Cli... The objective of this study is to determine whether IC14 treatment reduces markers of inflammation and disease biomarkers in ACM patients ...

2. withpower.com withpower.com/trial/phase-2-arrhythmogenic-right-ventricular-dysplasia-1-2024-0765a

IC14 for Arrhythmogenic Cardiomyopathy The goal of this clinical trial is to test IC14 (atibuclimab) in patients with arrhythmogenic cardiomyopathy (ACM) and who have an implantable cardoverter/ ...

3. ahajournals.org ahajournals.org/doi/10.1161/ATVBAHA.124.319980

Novel Therapeutics and Upcoming Clinical Trials Targeting ... Glucocorticoids were found to improve atrioventricular conduction in <50% of patients with cardiac sarcoidosis and might prevent LV deterioration, but available ...

4. implicitbioscience.com implicitbioscience.com/media-release-fda-approves-implicit-drug-for-clinical-study-in-heart-failure-and-first-patient-reported-to-be-responding-well-to-treatment/

Media Release | FDA Approves Implicit Drug for Clinical ... The US Food & Drug Administration has approved the commencement of a clinical study of Implicit Bioscience's monoclonal anti-CD14 antibody atibuclimab (IC14)

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06275893

IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy This proof-of-concept study will evaluate the safety, pharmacokinetics, and preliminary efficacy of IC14 administered via IV infusion in patients with ACM.

6. delta.larvol.com delta.larvol.com/Products/?ProductId=860e8153-2714-4b84-86bb-3ad83cfa52a0

atibuclimab (IC14) / Implicit Biosci Anti-CD14 treatment in patients with severe COVID-19: Clinical and biological effects in a Phase 2 randomized open-label adaptive platform clinical trial.

7. medchemexpress.com medchemexpress.com/atibuclimab.html?srsltid=AfmBOoroe3KeqzBZ4ieXux7FtM8uGz414X_sh_TFH37XxTRet-psZQJr

Atibuclimab (IC14) | CD14 Antibody Atibuclimab (IC14), is a chimeric monoclonal antibody directed against CD14 and is composed of murine variable and human IgG4 Fc regions.

8. implicitbioscience.com implicitbioscience.com/news/

News The US scientific journal Medicine has published a report of the first safety and biomarker study of IC14 in patients with ALS-MND.… Implicit Bioscience.