Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06275893
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-02-06
Brief Title:
IC14 Atibuclimab in Arrhythmogenic Cardiomyopathy
Sponsor:
Implicit Bioscience
Organization:
Implicit Bioscience
Study Overview
Official Title:
Phase 1b Study of IC14 in Arrhythmogenic Cardiomyopathy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to test IC14 atibuclimab in patients with arrhythmogenic cardiomyopathy ACM and who have an implantable cardoverterdefibrillator 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 patients pre-existing intracardiac cardioverterdefibrillator 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
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
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 PETCT 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 pharmacokineticpharmacodynamic 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 mgkg The study drug will be administered every three weeks via IV infusion for a total of 4 infusions 12 weeks of treatment
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 PETCT 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 pharmacokineticpharmacodynamic 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 mgkg The study drug will be administered every three weeks via IV infusion for a total of 4 infusions 12 weeks of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None