Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients

Part of paid clinical trials in Seattle, Washington.

Sponsor
Implicit Bioscience
Study ID
NCT06513949
Phase
PHASE2
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atibuclimab — BIOLOGICAL
    monoclonal antibody against human CD14
  • Placebo — OTHER
    Sterile normal saline for injection

Study Details

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.

Key Dates

Start date
Aug 15, 2025
Status verified
Aug 2025
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IC14 (atibuclimab)
    IC14 (atibuclimab) is a recombinant monoclonal antibody against human CD14
  • Placebo Comparator: Identical-appearing placebo
    Sterile normal saline

Primary Outcome Measure

Day 4 Oxygenation Index [ Time Frame: Day 1 through Day 4 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Harborview Medical CenterSeattleWashington98104
Linzee Mabrey, MD
Linzee Mabrey, MD (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98195
Linzee Mabrey, MD, MSc
206-731-4165
Eric Morrell, MD, PhD (PRINCIPAL_INVESTIGATOR)

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