Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI

Phase 1b Pilot Study of Atibuclimab (IC14) for Treatment of ST-Elevation Myocardial Infarction

Adults who have had an ST-elevation myocardial infarction and were treated with stent placement will receive an intravenous infusion of a monoclonal antibody in order to prevent further heart muscle damage. The goal is to learn if this treatment improves some measures of heart function and inflammation. The study treatment patients will be compared to patients who receive placebo (inactive treatment).

Study Overview

• Status: Active, not recruiting
• Conditions: STEMI; STEMI - ST Elevation Myocardial Infarction (MI); Stent Implantation; STEMI (ST Elevation MI)
• Intervention / Treatment: Drug: Atibuclimab (IC14), 20 mg/kg intravenously, once; Other: Placebo, 150 mL intravenously, once

Detailed Description

Randomized, double-blind, placebo-controlled pilot study to evaluate the safety, exploratory efficacy, and pharmacokinetics of IC14 (atibuclimab) administered via a single IV infusion to patients with STEMI treated with percutaneous intervention. In additional to optional CCR2+ myocardial imaging, biomarkers, cardiac function and patient-reported outcome measures will be reported.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Virginia
    • Charlottesville, Virginia, United States, 22908-1394
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Acute myocardial infarction with ST elevation at the J-point in two contiguous leads as determined by ECG.
2. TIMI grade 0 (no flow) or grade 1 (penetration without perfusion) of the culprit artery on initial coronary angiogram
3. Symptom onset prior to PCI of ≤12 hours
4. Planned to receive the local standard of care for treatment of their STEMI and follow up which must include percutaneous coronary intervention (PCI)
5. Ability to infuse study drug within 12 hours of PCI
6. Age ≥18 years, willing and able to provide written informed consent and to comply with the protocol (i.e., reporting of symptoms)
7. Capable of completing study visits

8. Females participating in the study must meet one of the following criteria:

   1. Postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year);
   2. Surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) for at least 6 months; or
   3. 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 treatment
9. Males who have not had a vasectomy must use appropriate contraception methods (barrier or abstinence) until 30 days after treatment

Exclusion Criteria:

An individual fulfilling any of the following criteria is to be excluded from enrollment in the study:

1. Killip Classification for Heart Failure Class III (acute pulmonary edema) or IV (cardiogenic shock)
2. Severe aortic or mitral valve disease
3. Failure to reperfuse, vascular dissection, cardiac perforation, cardiac arrest, requirement for mechanical circulatory support, or acute respiratory failure requiring ventilatory support
4. Major hemodynamic instability or uncontrolled ventricular arrhythmias
5. Planned or conducted thrombolytic therapy for treatment of this STEMI event
6. Planned or conducted coronary artery bypass graft
7. Previous major vascular intervention within the last 4 weeks
8. Major surgery within the last 6 weeks
9. Evidence of an active gastrointestinal or urogenital bleeding
10. Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (including oral corticosteroids at a prednisone equivalent dose of ≥0.5 mg/kg/day but not including inhaled or low-dose oral corticosteroids, non-steroidal anti-inflammatory drugs, or colchicine).
11. Chronic inflammatory disorder (i.e., rheumatoid arthritis, systemic lupus erythematosus).
12. Active infection (of any type), including chronic/recurrent infectious disease (including HBV, HCV, and HIV/AIDS), but excluding HCV+ with undetectable plasma RNA.
13. Neutropenia (<1,500/mm3 or <1,000/mm3 in Black/African American patients).
14. Active malignancy, excluding carcinoma in situ [any location] or localized non-melanoma skin cancer
15. Participation in any study using an investigational drug or device within 30 days or within 5 half-lives of the investigational drug (whichever is longer) of entry into this study.
16. Life expectancy of less than 1 year due to non-cardiac pathology
17. History of allergic reaction to atibuclimab (IC14), any monoclonal antibody, or any other component used in the study (including contrast media)
18. Body weight >300 pounds (weight limit of the PET/CT table)
19. Known severe renal (creatinine clearance <30 mL/min) or hepatic insufficiency as well as alanine transaminase (ALT) elevation ≥ 3x upper limit of normal; isolated AST-elevation is not considered an exclusion criterion from study participation
20. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental drug intervention; monoclonal antibody against CD14	Drug: Atibuclimab (IC14), 20 mg/kg intravenously, once; monoclonal antibody against CD14
Placebo Comparator: Placebo; Identical-appearing normal saline for injection, intravenous, once	Other: Placebo, 150 mL intravenously, once; sterile normal saline for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (safety and tolerability)	Treatment-emergent adverse events	Day 1-29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CCR2+ cell myocardial infiltration (optional)	Characterization of CCR2+ cell myocardial infiltration mean standard uptake value (SUVmean) and change from 48 hours measured by myocardial PET/CT imaging at Day 15	48 hours and Day 15
Biomarker C-Reactive Protein	Change from baseline	Day 4, 15, 29
Biomarker White Blood Cell Count	Change from baseline	Day 4, 15, and 29
Biomarker Fibrinogen	Change from baseline	Day 4, 15, 29
Biomarker Interleukin 6	Change from baseline	Day 4, 15, and 29
Biomarker Interleukin-1	change from baseline	Day 4, 15, and 29
Biomarker Troponin I	change from baseline	Day 4, 15, and 29
Single-cell RNASeq	change from baseline	Day 4, 15, and 29
Cardiac death or readmission for heart failure	Cardiac death defined as death due to acute MI, sudden cardiac death, HF, stroke, cardiovascular procedure, cardiovascular hemorrhage, or other cardiovascular cause.; Heart failure readmission, defined as an event in which the patient is admitted to the hospital with a primary diagnosis of HF, the length of stay is at least 24 hours (or extends over a calendar date), the patient exhibits new or worsening symptoms of HF on presentation, has objective evidence of new or worsening HF, and receives initiation or intensification of treatment specifically for HF.	Day 1-90
Left Ventricular Ejection Fraction	Change from baseline, measured by echocardiography	Day 1, Day 90
N-terminal pro B-type natriuretic peptide	blood test measurement of heart failure	Day 90
New York Heart Association Class	Measurement of cardiac status	Day 90
Kansas City Cardiomyopathy Questionnaire	Patient-reported outcome measure of health status and function	Day 90

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic profile of serum IC14 level, including serum half life and maximum serum concentration	Serum IC14 levels	baseline, 15 minutes, 6 hours, Day 4, Day 15, Day 22, Day 29
Pharmacodynamics	Percent monocyte CD14 receptor occupancy	Day 22, Day 29
Immunogenicity	Anti-drug antibodies	baseline, Day 29, Day 90

Collaborators and Investigators

• Sponsor: Implicit Bioscience
• Collaborators: Washington University School of Medicine; University of Virginia
• Investigators: Principal Investigator: Marc Sintek, MD, PI; Principal Investigator: Antonio Abbate, MD, PhD, PI

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: antiinflammatory; anti-CD14; IC14; atibuclimab; monoclonal antibody against CD14
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; atibuclimab
• Other Study ID Numbers: STEMI01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Included in publication supplemental materials and provided to central data base
• IPD Sharing Time Frame: study completion
• IPD Sharing Access Criteria: public access through journal website and/or ClinicalTrials.gov website listing
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No