Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients

NCT06513949 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ARDS01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

ARDS; IC14

Outcome Measures

Primary Outcomes (1)

• Day 4 Oxygenation Index

  (mean airway pressure x fraction of inspired oxygen \[FiO2\] x100)/ partial pressure of oxygen \[PaO2\]

  Day 1 through Day 4

Secondary Outcomes (13)

• Biomarkers of injury and inflammation measured in bronchoalveolar lavage fluid

  Day 4

• Biomarkers of injury and inflammation measured in plasma

  Day 4

• Oxygenation index

  Days 7 and 14

• Oxygen saturation index

  Days 4, 7, and 14

• P:F ratio

  Days 4, 7, and 14

Other Outcomes (2)

• Ventilator-free Days

  Days 1-28

• Mortality

  Day 1-28

Study Arms (2)

IC14 (atibuclimab)

EXPERIMENTAL

IC14 (atibuclimab) is a recombinant monoclonal antibody against human CD14

Biological: Atibuclimab

Identical-appearing placebo

PLACEBO COMPARATOR

Sterile normal saline

Other: Placebo

Interventions

Atibuclimab BIOLOGICAL

monoclonal antibody against human CD14

Also known as: IC14

IC14 (atibuclimab)

Placebo OTHER

Sterile normal saline for injection

Identical-appearing placebo

Eligibility Criteria

• Age: 18 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Implicit Bioscience: lead
• University of Washington: collaborator

Study Sites (2)

Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury

Interventions

atibuclimab

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Study Officials

• Linzee Mabrey, MD, MsC

  Unversity of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linzee Mabrey, MD, MSc

CONTACT

(206) 897-5051; mflinzee@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identical-appearing placebo prepared by research pharmacist
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients hospitalized with ARDS will be randomized to treatment with anti-CD14 monoclonal antibody, IC14, or placebo and evaluated for impact of treatment on severity of lung injury as measured by day 4 oxygenation index. Secondary objectives include determination of systemic and alveolar inflammatory responses; indices of oxygenation and illness severity; safety; and IC14 levels in bronchoalveolar lavage fluid and serum. Exploratory objectives include determining the effect of treatment on duration of mechanical ventilation, mortality, and feasibility of measuring presepsin, a CD14 pathway-specific biomarker at baseline using rapid testing

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 22, 2024
• Study Start: August 15, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)