NCT06513949

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Implicit Bioscience · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a 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 (ARDS). CD14 is a key mediator in recognition of molecular markers of tissue damage (damage-associated molecular patterns, DAMPs) and infection (pathogen-associated molecular patterns, PAMPS). The primary objective of the study is to determine the efficacy of IC14 in patients hospitalized with ARDS for reducing the severity of lung injury as measured by the day 4 Oxygenation Index (OI) assessed as a continuous measure (mean airway pressure x fraction of inspired oxygen \[FiO2\] x 100/partial pressure of oxygen \[PaO2\]). OI captures severity of hypoxemia and concurrent intensity of ventilatory support. Secondary objectives include determining whether IC14 reduces the systemic and alveolar inflammatory response, and improves indices of oxygenation and illness severity. Exploratory endpoints include determining the effect of CD14 blockade on duration of mechanical ventilation and mortality in patients hospitalized with ARDS. Pharmacokinetic \[PK\]/Pharmacodynamic \[PD\] endpoints include determining day 4 IC14 levels in bronchoalveolar fluid (BALF) vs. serum, and determining the feasibility of measuring blood presepsin levels, a CD14-pathway specific biomarker for rapid assessment.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Atibuclimab	monoclonal antibody against human CD14
OTHER	Placebo	Sterile normal saline for injection

Timeline

• Start date: 2025-08-15
• Primary completion: 2027-09-01
• Completion: 2027-12-01
• First posted: 2024-07-22
• Last updated: 2025-08-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study