RecruitingPhase 2NCT06513949

Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Anti-CD14 Treatment With a Recombinant Chimeric Monoclonal Antibody (IC14) in Hospitalized Patients With Acute Respiratory Distress Syndrome

Sponsor

Implicit Bioscience

Enrollment

56 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Lung Injury Acute Respiratory Distress Syndrome Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)Adult Respiratory Distress Syndrome

Summary

Hospitalized patients with ARDS will be randomized to intravenous treatment with a monoclonal antibody against CD14, called IC14, or placebo. They will be followed for 28 days. The primary outcome is the day 4 oxygenation index assessed as a continuous measure.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

Patients may be included in the study only if they meet all the following criteria:
Adult patients (18+) on mechanical ventilations with acute respiratory distress syndrome (ARDS) by Berlin Criteria (≤48 hours)
P:F ratio \< 300
Positive end-expiratory pressure (PEEP) ≥5 cm H2O
Bilateral opacities on chest x-ray or chest computerized tomography (CT)-- not fully explained by effusions, lobar/lung collapse, or nodules
Respiratory failure not fully explained by cardiac failure or fluid overload
Within 1 week of known clinical insult or new or worsening respiratory symptoms
i. Common Risk Factors for ARDS: Pneumonia, aspiration, inhalation injury, pulmonary contusion, pulmonary vasculitis, drowning, non-pulmonary sepsis, major trauma, pancreatitis, severe burns, non-cardiogenic shock, drug overdose, multiple transfusions
Patient or Legal authorized representative able to understand and give written informed consent

Exclusion Criteria26

An individual fulfilling any of the following criteria should be excluded from enrollment in the study:
Significant pre-existing organ dysfunction prior to hospitalization
Lung: Currently receiving home oxygen therapy as documented in medical record
Heart: Pre-existing congestive heart failure defined as an ejection fraction \<20% as documented in the medical record
Renal: End-stage renal disease requiring renal replacement therapy or estimated glomerular filtration rate (eGFR) \<30 mL/min.
Liver: Severe chronic liver disease defined as Child-Pugh Class C or hepatic transaminases \>5 times upper limit of normal
Hematologic: Baseline platelet count \<50,000/mm3
Presence of co-existing infection, including, but not limited to:
HIV infection not virally suppressed and with pre-hospitalization CD4 counts ≤ 500 cell/mm3
Active tuberculosis or a history of inadequately treated tuberculosis
Active hepatitis B or hepatitis C viral infection
Current treatment, or treatment within 30 days or five half-lives (whichever is longer) with etanercept (Enbrel®), infliximab (Remicade®), adalimumab (Humira®), certolizumab (Cimzia®), golimumab (Simponi®), anakinra (Kineret®), rilonacept (Arcalyst®), tocilizumab (Actemra®), sarilumab (Kevzara®), siltuximab (Sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments
Receiving comfort measures only
Requiring \>2 vasopressors
Pregnant
Prisoners
History of hypersensitivity or idiosyncratic reaction to IC14
Women who are currently breastfeeding
Bronchoscopy safety exclusions
P:F \<100 on 100% FiO2
Mean pulmonary artery pressure \> 55 mmHg
Marked cardiovascular instability (Mean arterial pressure \<55 mmHg with vasopressor support)
Intracranial pressure ≥20 mmHg
Acute ischemic heart disease (unstable angina or ST-elevation myocardial infarction or Type 1 non-ST-elevation myocardial infarction)
Supported on extracorporeal membrane oxygenation
Endotracheal tube \<6.5 mm