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Arrhythmogenic Right Ventricular DysplasiaPhase 1/2NCT06275893

IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy

A Phase 1/2 study testing IC14 in people with Arrhythmogenic Right Ventricular Dysplasia and Arrhythmogenic Left Ventricular Cardiomyopathy, run by Implicit Bioscience at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IC14
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
2 sitesUnited States
Study dates
29 Mar 2024to 15 Apr 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients are eligible for the study if all of the following criteria are met:
  • Age ≥ 18 years
  • Diagnosis of arrhythmogenic cardiomyopathy and: 1) meeting the 2020 Modified Task Force Criteria as affected;
  • Left ventricular ejection fraction of ≥30%
  • Functioning implantable cardioverter/defibrillator with remote interrogation capability
  • One of the following: 1) a history of ventricular tachycardia or ventricular fibrillation (VF); 2) ≥500 ventricular premature contractions (VPCs) in 24 hours on the most recent 24-hour Holter monitor recording; or 3) C-reactive protein >=1.5 mg/mL
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  • Agreement by subject, physician, and cardiologist to not change concomitant ACM medications or to conduct catheter ablation during study participation unless needed for management of life-threatening conditions
  • Capable and willing to provide informed consent
  • Capable of completing study visits
  • Females participating in the study must meet one of the following criteria:
  • Surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) for at least 6 months or postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year) or
  • If not postmenopausal, agree to use a double method of contraception, one of which is a barrier method (e.g., intrauterine device plus condom, spermicidal gel plus condom) until 30 days after the IC14 treatment and have negative human chorionic gonadotropin (β-hCG) test for pregnancy at Screening
  • Males who have not had a vasectomy must use appropriate contraception methods (barrier or abstinence) until 30 days after IC14 treatment

Who cannot join

  • A patient fulfilling any of the following criteria is to be excluded from enrollment in the study:
  • Prior myocardial infarction
  • Receiving continuous infusion of antiarrhythmic medication at time of enrollment
  • Previous major vascular intervention within 4 weeks
  • NYHA heart failure class IV, except palpitations
  • Major surgery within 6 weeks
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  • Patient has participated in any study using an investigational drug or device within 30 days
  • Life expectancy of less than 1 year due to non-cardiac pathology
  • History of allergic reaction to atibuclimab (IC14) or any monoclonal antibody drug product or other CD14-derived drug product or any component used in the study (including contrast media)
  • Known severe renal (creatinine clearance <30 mL/min/m2) or hepatic insufficiency as well as alanine transaminase (ALT)/aspartate transaminase (AST) elevations ≥ 3x upper limit normal (ULN); isolated AST elevation is not considered an exclusion criterion from study participation
  • Current or planned use of continuous high-dose corticosteroids (short courses of corticosteroids are allowable)
  • Chronic immunosuppression with disease-modifying anti-rheumatic drugs (DMARDS)
  • Any clinically significant abnormality identified at the time of Screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study
  • Patients who will be inaccessible due to geographic or social factors during treatment or follow-up

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Phase 1b Study of IC14 in 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/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.

Read the detailed description

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

In preclinical studies, anti-CD14 treatment prevented the development of ventricular dysfunction and cardiac damage in a mouse model of arrhythmogenic cardiomyopathy.

The objective of this study is to determine whether IC14 treatment reduces markers of inflammation and disease biomarkers in ACM patients treated with IC14. Secondary objectives are to further characterize the effect of IC14 treatment on CCR2+ cell myocardial infiltration measured by myocardial positron emission tomography (PET)/CT imaging, ventricular premature contractions (VPCs), other arrhythmias, ICD discharges, NYHA functional classification, and quality of life.

To characterize safety of IC14, the following assessments are to be performed: clinical biochemistry (safety analyses), ECG, ECHO, adverse events (AEs), serious adverse events (SAEs), and formation of anti-drug antibodies.

Finally, pharmacokinetic/pharmacodynamic parameters will be conducted. These include blood test measurements levels of the drug and its binding to its target in the serum and on cells.

This study will assign 5 patients to intravenous (IV) administration of IC14 (atibulcimab) at 20 mg/kg. The study drug will be administered every three weeks via IV infusion, for a total of 4 infusions (12 weeks of treatment).

Being tested
IC14
Keywords
arrhythmia, cardiac genetic disorder, desmoglein mutation
Medical subject headings
Arrhythmogenic Right Ventricular Dysplasia, Arrhythmogenic Right Ventricular Dysplasia, Familial, 1, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IC14Biological

    Also called (atibuclimab)

    recombinant monoclonal antibody directed against cluster of differentiation 14 (CD14) antigen

Study groups in NCT06275893
Study groupRoleWhat they receive
IC14 (atibuclimab)ExperimentalIC14 (atibuclimab) 20 mg/kg intravenously every 3 weeks for 12 weeks (4 doses)
Receives: Biological: IC14

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: Treatment-emergent adverse events and serious adverse events

    Treatment-emergent adverse events and serious adverse events

    Measured: Baseline through 14 weeks

  2. Safety: Incidence of anti-drug antibodies

    Incidence of anti-drug antibodies

    Measured: Baseline, 4 weeks, and 14 weeks

Secondary outcomes (18)

  1. Inflammatory biomarker C-reactive protein

    Change in concentration from baseline at 12 weeks

    Measured: Baseline, 12 weeks

  2. CCR2+ Myocardial Imaging (optional)

    Mean change in CCR2+ cell myocardial infiltration measured by CCR2+ PET/CT imaging (standardized uptake value)

    Measured: Baseline compared to 12 weeks

  3. Ventricular tachycardia

    Number of ventricular tachycardia runs in a 7-day Holter monitor

    Measured: Baseline compared to 12 weeks

  4. Ventricular premature contractions

    Frequency of ventricular premature contractions in a 7-day Holter monitor

    Measured: Baseline compared to 12 weeks

  5. Sustained and non-sustained ventricular tachycardia

    Number of episodes of sustained and non-sustained ventricular tachycardia documented by ICD

    Measured: Baseline through 12 weeks

  6. Treated ventricular tachycardia

    Number of episodes of treated ventricular tachycardia (pacemaker and/or defibrillation) by ICD

    Measured: Baseline through 12 weeks

  7. Atrial premature contractions

    Number of atrial premature contractions in a 7-day Holter monitor

    Measured: Baseline compared to 12 weeks

  8. New York Heart Association (NYHA) Functional Class

    Change in NYHA Functional Class Questionnaire

    Measured: Baseline compared to 12 weeks

  9. Implantable cardioverter/defibrillator (ICD) discharges

    Frequency of ICD discharges (appropriate and/or inappropriate)

    Measured: Baseline through 12 weeks

  10. Quality-of-Life Score determined by the Kansas City Cardiomyopathy Questionnaire

    Change in Quality-of-Life Score determined by the Kansas City Cardiomyopathy Questionnaire, range 0 (very poor) to 65 (excellent)

    Measured: Baseline compared to 12 weeks

  11. Disease biomarker Troponin I

    Change in concentration from baseline at 12 weeks

    Measured: Baseline, 12 weeks

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

    Change in concentration from baseline at 12 weeks

    Measured: Baseline, 12 weeks

  13. Inflammatory biomarker interleukin (IL)1-beta

    Change in concentration from baseline at 12 weeks

    Measured: Baseline, 12 weeks

  14. Pharmacokinetics: Serum IC14 concentration versus time curve

    Area under the serum concentration versus time curve (AUC)

    Measured: Baseline through 14 weeks

  15. Pharmacokinetics: Peak serum IC14 concentration

    Peak serum IC14 concentration

    Measured: Baseline through 14 weeks

  16. Pharmacokinetics: Half life

    Half-life of serum IC14 concentration

    Measured: Baseline through 14 weeks

  17. Pharmacodynamics: Receptor Occupancy

    Measurement of monocyte membrane CD14 receptor occupancy

    Measured: Baseline through 14 weeks

  18. Pharmacodynamics: Effective Concentration 95%

    Estimation of serum concentration of IC14 to achieve 95% monocyte membrane receptor occupancy

    Measured: Baseline through 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2024
  2. Study start29 Mar 2024
  3. Primary completion15 Aug 2025
  4. Study completion15 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label treatment with IC14. Participant outcomes will be compared to baseline. Pharmacokinetics will be measured.
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06275893
Sponsor's protocol ID
ACM01
Status last verified
Apr 2026
First submitted
6 Feb 2024
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IC14 in people with Arrhythmogenic Right Ventricular Dysplasia and Arrhythmogenic Left Ventricular Cardiomyopathy, run by Implicit Bioscience at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Treatment-emergent adverse events and serious adverse events (time frame: Baseline through 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06275893.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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