IC14 for Treatment of Acute Decompensated Heart Failure

NCT06556810 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: IC14HF01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to learn if drug atibuclimab (IC14) works to treat adults hospitalized with acute decompensated heart failure (ADHF). It will also learn about the safety of IC14. The main questions it aims to answer are: Is the drug IC14 safe in patients with ADHF? What are the IC14 drug levels in the bloodstream after treatment with IC14? What is the impact of IC14 treatment on markers of disease in the bloodstream? What is the impact of IC14 treatment on measures of heart failure? There is no placebo arm in this study. Participants will: Take drug IC14 once via an intravenous infusion After the infusion, be visited in the hospital or visit the clinic 5 times for checkups and tests Answer questions about their medical status via a phone call 3 months after the infusion

Conditions

Acute Decompensated Heart Failure

Keywords

Acute Decompensated Heart Failure; Congestive Heart Failure; Left Heart Failure; Heart Failure

Outcome Measures

Primary Outcomes (2)

• Safety of IC14 treatment

  safety measured by treatment-emergent adverse events, including abnormal laboratory values

  0-28 days

• Anti-Drug Antibodies following IC14 treatment

  anti-drug antibodies

  0-28 days

Secondary Outcomes (16)

• C-reactive protein, biomarker of inflammation

  baseline, 24 hours, 72 hours or discharge, Day 10, Day 29

• B-type natriuretic peptide, biomarker of heart failure

  baseline, 24 hours, 72 hours or discharge, Day 10, Day 29

• Estimated glomerular filtration rate, biomarker of heart failure

  baseline, 72 hours or discharge, Day 10, Day 29

• Urine sodium

  baseline, 24 hours, 72 hours or discharge

• Dyspnea Visual Analogue Scale

  baseline, 24 hours, 72 hours, Day 10, Day 29, and 3 months (virtual).

Study Arms (1)

IC14 (atibuclimab)

EXPERIMENTAL

20 mg/kg intravenously once at baseline

Drug: Atibuclimab (IC14)

Interventions

Atibuclimab (IC14) DRUG

Atibuclimab (IC14) is a monoclonal antibody against human cluster of differentiation (CD)14, a key signaling molecule of the innate immune system

Also known as: anti-CD14 monoclonal antibody

IC14 (atibuclimab)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be included in the study only if they meet all of the following criteria:
• Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of both conditions listed below:
• dyspnea or respiratory distress or tachypnea at rest or with minimal exertion; and
• evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met):
• Pulmonary congestion/edema a physical exam OR chest x-ray;
• plasma BNP levels ≥200 pg/ml or N-terminal-proBNP ≥600 pg/ml; or
• invasive measurement of left ventricular end-diastolic pressure (LVEDP) \>18 mmHg or of pulmonary artery occluding pressure (wedge pressure) \>16 mmHg.
• The patient has a prior documentation of impaired left ventricular systolic function (left ventricular ejection fraction \<40%) at most recent assessment by any imaging modality (within 12 months).
• The patient is symptomatic for moderate to severe dyspnea at time of enrollment as indicated by a score on the visual analog scale for dyspnea of 40 or more (in a scale of 1 to 100, where 0 is no shortness of breath and 100 is extremely short of breath) in the prior 12 hours.
• The patient has recently received (past 24 hours) or is scheduled to received intravenous loop diuretics.
• The patient is of age ≥21 years old, willing and able to provide written informed consent and to comply with the protocol (i.e., reporting of symptoms).
• The patient has screening plasma C-reactive protein levels \>3 mg/L (0.3 mg/dL).
• Males and females of childbearing potential must use effective contraception.

You may not qualify if:

• The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias.
• Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study including but not limited to acute coronary syndromes; uncontrolled hypertension or orthostatic hypotension; tachy- or brady-arrhythmias; acute or chronic pulmonary disease; or neuromuscular disorders affecting respiration.
• Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT) or valve surgeries.
• Previous or planned implantation of left ventricular assist devices or heart transplant.
• Current or planned use of intravenous inotropes.
• 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).
• Chronic inflammatory disorder (i.e., rheumatoid arthritis, systemic lupus erythematosus).
• Active infection (of any type), including chronic/recurrent infectious disease (including hepatitis B virus, hepatitis C virus, and HIV/AIDS) - but excluding HCV+ with undetectable plasma RNA.
• Active malignancy - excluding carcinoma in situ \[any location\] or localized non-melanoma skin cancer.
• Any comorbidity limiting survival or ability to complete the study, including end-stage heart failure.
• Stage V kidney disease or on renal-replacement therapy or renal transplant recipient.
• Neutropenia (\<1,500/mm3 or \<1,000/mm3 in Black/African-American patients).
• Pregnancy.
• Hypersensitivity to IC14 or previous adverse reaction to antibody-based treatments.

Sponsors & Collaborators

• Implicit Bioscience: lead
• University of Virginia: collaborator
• Virginia Commonwealth University: collaborator

Study Sites (2)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

atibuclimab

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Antonio Abbate, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Hospitalized patients with acute decompensated heart failure will be treated with an intravenous dose of IC14 and evaluated for safety, pharmacokinetics/pharmacodynamics, and preliminary clinic response

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 16, 2024
• Study Start: October 17, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): August 28, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)