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Acute Decompensated Heart FailurePhase 1/2NCT06556810

IC14 for Treatment of Acute Decompensated Heart Failure

A Phase 1/2 study testing Atibuclimab (IC14) in people with Acute Decompensated Heart Failure, run by Implicit Bioscience at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Acute Decompensated Heart Failure
What is being tested?
Atibuclimab (IC14)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesUnited States
Study dates
17 Oct 2024to 28 Aug 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

Official title: Phase 1b Pilot Study to Evaluate Atibuclimab (IC14) for Treatment of Acute Decompensated Heart Failure

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.

Read more

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

Read the detailed description

The proposed investigation is a pilot study to evaluate the safety and exploratory efficacy of IC14 administered via IV infusion in patients with ADHF.

The primary objective of this study is to determine safety of intravenous IC14 in patients acute decompensated heart failure. Exploratory biomarkers, clinical outcomes, and pharmacokinetic/pharmacodynamic measurements will be used to design further study of clinical efficacy of IC14 in the treatment of ADHF.

To characterize safety of IC14 administered via IV infusion, the following assessments are to be performed: treatment-emergent adverse events (AEs), safety laboratory studies, serious adverse events (SAEs), and presence of anti-drug antibodies.

To evaluate the effect of IC14, biomarkers including high-sensitivity C-reactive protein (hsCRP), B-type natriuretic peptide (BNP), urine sodium, and estimated glomerular filtration rate (eGFR) are measured at baseline and repeatedly after IC14 treatment. CRP is an established prognostic marker in heart failure that reflects systemic interleukin-6 as well as interleukin-1 activities. Measuring CRP area-under-the-curve allows for integrating measurements across multiple time points to quantify the acute inflammatory response more accurately.

Preliminary clinical efficacy will be measured by evaluating heart failure and cardiac performance outcomes at Day 10, including Dyspnea Visual Analogue Scale, Congestion Score, Doppler echocardiogram, non-invasive hemodynamics, bioimpedance analysis, cardiopulmonary exercise test and Kansas City Cardiomyopathy Questionnaire.

Pharmacokinetics will determine the serum concentration of IC14 over time. Pharmacokinetic measurements will be correlated with pharmacodynamic markers of IC14 biologic effect, including monocyte CD14 receptor occupancy.

Being tested
Atibuclimab (IC14)
Keywords
Acute Decompensated Heart Failure, Congestive Heart Failure, Left Heart Failure, Heart Failure
Medical subject headings
Heart Failure

What participants receive

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

  • Atibuclimab (IC14)Drug

    Also called anti-CD14 monoclonal antibody

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

Study groups in NCT06556810
Study groupRoleWhat they receive
IC14 (atibuclimab)Experimental20 mg/kg intravenously once at baseline
Receives: Drug: Atibuclimab (IC14)

What is being measured

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

  1. Safety of IC14 treatment

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

    Measured: 0-28 days

  2. Anti-Drug Antibodies following IC14 treatment

    anti-drug antibodies

    Measured: 0-28 days

Secondary outcomes (16)

  1. C-reactive protein, biomarker of inflammation

    area under the curve (0 [normal]; 1-10 mg/dL [moderate elevation]; > 10 mg/dL [marked elevation] per time)

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

  2. B-type natriuretic peptide, biomarker of heart failure

    absolute value (<100 pg/mL [normal], >=100 pg/mL [heart failure])

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

  3. Estimated glomerular filtration rate, biomarker of heart failure

    absolute value(>=90 ml/min/1.73 m2 [normal]; 60-89 [possible impairment]; 15-59 [impairment]; <15 [renal failure])

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

  4. Urine sodium

    absolute value (40-220 milliequivalents/day)

    Measured: baseline, 24 hours, 72 hours or discharge

  5. Dyspnea Visual Analogue Scale

    10-cm Visual Analogue Scale

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

  6. Congestion Score

    a composite score of one point for peripheral edema, jugular venous distension ≥10 cm, pulmonary rales, or S3 gallop (0 [good] to 4 [poor])

    Measured: baseline, 24 hours, 72 hours, Day 10, and Day 29

  7. Loop diuretic requirement

    total loop diuretic requirement (in furosemide equivalents) as calculated from concomitant medication listings

    Measured: during the first 72 hours of hospitalization

  8. Doppler echocardiogram

    Change from baseline in left ventricular ejection fraction (left ventricular ejection fraction (>52% male, >54% female [normal])

    Measured: baseline, Day 10

  9. Echocardiogram

    Change from baseline in left ventricular global longitudinal strain (normal 21%)

    Measured: baseline, Day 10

  10. Non-invasive hemodynamic assessment

    Measure of cardiac output

    Measured: baseline, 24 hours, 72 hours, Day 1

  11. Bioimpedance analysis

    Measure of extracellular fluid as a marker of heart failure

    Measured: baseline, 24 hours, 72 hours, Day 1

  12. Cardiopulmonary exercise test

    aerobic exercise capacity (peak oxygen consumption [VO2]; <30 mL/kg/min [sedentary])

    Measured: Day 10

  13. Pharmacokinetic determination of half-life, maximum concentration and area-under-the-curve

    serum IC14 level

    Measured: baseline, 15 minutes, 6 hours, 24 hours, 72 hours, Day 10, Day 29

  14. Pharmacodynamics

    Duration of monocyte CD14 receptor occupancy >90%

    Measured: Day 10, Day 29

  15. Ex-vivo leukocyte release assay

    Lipopolysaccharide-stimulated release of interleukin 6

    Measured: Day 10

  16. Kansas City Cardiomyopathy Questionnaire

    Questionnaire for the patient that reports on 23 aspects of how heart failure affects the patient's life (0[worst symptoms/limitations]-100[least symptoms/limitations and excellent quality of life])

    Measured: baseline to 3 months

Timeline

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

  1. First posted16 Aug 2024
  2. Study start17 Oct 2024
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion28 Aug 2026 (estimated)

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
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
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06556810
Sponsor's protocol ID
IC14HF01
Status last verified
Mar 2026
First submitted
8 Aug 2024
Last updated
27 Mar 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 Atibuclimab (IC14) in people with Acute Decompensated Heart Failure, 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 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?

This study is still under way. Results are not available in the source record yet.

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 of IC14 treatment (time frame: 0-28 days). 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 NCT06556810.

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 27 Mar 2026.

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