Acute Respiratory Distress SyndromePhase 2NCT06513949
Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients
A Phase 2 study testing Atibuclimab in people with Acute Respiratory Distress Syndrome and Adult Respiratory Distress Syndrome, run by Implicit Bioscience at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Adult Respiratory Distress Syndrome, Acute Lung Injury
- What is being tested?
- Atibuclimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jun 2026to 1 Jun 2029
- Phase
- Phase 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 18 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 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
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- Within 1 week of known clinical insult or new or worsening respiratory symptoms
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Harborview Medical Center
Seattle, Washington, 98104
Linzee Mabrey, MD
Linzee Mabrey, MD
- Recruiting
University of Washington
Seattle, Washington, 98195
Linzee Mabrey, MD, MSc, (206) 731-4165, mflinzee@uw.edu
Eric Morrell, MD, PhD
About this study
Official title: 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
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.
Read the 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)
- Being tested
- Atibuclimab, Placebo
- Keywords
- ARDS, IC14
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtibuclimabBiological
Also called IC14
monoclonal antibody against human CD14
PlaceboOther
Sterile normal saline for injection
| Study group | Role | What they receive |
|---|---|---|
| IC14 (atibuclimab) | Experimental | IC14 (atibuclimab) is a recombinant monoclonal antibody against human CD14 Receives: Biological: Atibuclimab |
| Identical-appearing placebo | Placebo comparator | Sterile normal saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 4 Oxygenation Index
(mean airway pressure x fraction of inspired oxygen [FiO2] x100)/ partial pressure of oxygen [PaO2]
Measured: Day 1 through Day 4
Secondary outcomes (13)
Biomarkers of injury and inflammation measured in bronchoalveolar lavage fluid
Interleukin(IL)-6
Measured: Day 4
Biomarkers of injury and inflammation measured in plasma
Interleukin(IL)-6
Measured: Day 4
Oxygenation index
(mean airway pressure x FiO2 x100)/PaO2
Measured: Days 7 and 14
Oxygen saturation index
(mean airway pressure x FiO2 x100)/peripheral oxygen saturation [SpO2]
Measured: Days 4, 7, and 14
P:F ratio
Ratio of partial pressure of arterial oxygen (P) to fraction of inspired oxygen (F)
Measured: Days 4, 7, and 14
S:F ratio
Ratio of the arterial oxygen saturation (S) to fraction of inspired oxygen (F)
Measured: Days 4, 7, and 14
Sequential Organ Failure Assessment (SOFA) Score (range 0 [best] to 24 [worst])
Disease severity scale
Measured: Days 4, 7, and 14
Time to blood presepsin level
Time from study consent to measurement completion of blood presepsin level via the PATHFASTTM instrument
Measured: Days 0-4
Cumulative incidence of run failures
Defined as not completing presepsin measurement between consent and infusion of study drug
Measured: Days 0-1
Cumulative incidence of protocol-specified exempt serious events
protocol-specified exempt serious events
Measured: Days 1-28
Cumulative incidence of grade 3 and 4 clinical and laboratory adverse events
Common Toxicity Criteria for Adverse Events version 5.0
Measured: Days 1-28
Cumulative incidence of serious adverse events
Serious adverse events standard definition
Measured: Days 1-28
Cumulative incidence of adverse events of special interest
Adverse events of special interest for test article and bronchoalveolar lavage
Measured: Days 1-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start17 Jun 2026
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implicit Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- Linzee Mabrey, MD, MsC, Principal investigator, Unversity of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513949
- Sponsor's protocol ID
- ARDS01
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06513949
- Acronym / sponsor ID
- ARDS01
- Conditions
- Acute Respiratory Distress Syndrome, Adult Respiratory Distress Syndrome, Acute Lung Injury, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
- Keywords
- ARDS, IC14
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Implicit BioscienceIndustry (pharma, biotech, devices)
- Collaborators
- University of Washington
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| IC14 (atibuclimab) | Experimental | Biological: AtibuclimabIC14 (atibuclimab) is a recombinant monoclonal antibody against human CD14 |
| Identical-appearing placebo | Placebo comparator | Other: PlaceboSterile normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients (18+) on mechanical ventilations with acute respiratory distress syndrome (ARDS) by Berlin Criteria (≤48 hours)
- Patient or Legal authorized representative able to understand and give written informed consent
Key exclusion criteria (26 listed)
- An individual fulfilling any of the following criteria should be excluded from enrollment in the study:
- Significant pre-existing organ dysfunction prior to hospitalization
- Presence of co-existing infection, including, but not limited to:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtibuclimabAlso: IC14monoclonal antibody against human CD14 | Biological | IC14 (atibuclimab) |
| PlaceboSterile normal saline for injection | Other | Identical-appearing placebo |
Primary outcome
Day 4 Oxygenation Index
Time frame: Day 1 through Day 4
(mean airway pressure x fraction of inspired oxygen [FiO2] x100)/ partial pressure of oxygen [PaO2]
13 secondary outcomes
Biomarkers of injury and inflammation measured in bronchoalveolar lavage fluid
Time frame: Day 4
Biomarkers of injury and inflammation measured in plasma
Time frame: Day 4
Oxygenation index
Time frame: Days 7 and 14
Oxygen saturation index
Time frame: Days 4, 7, and 14
P:F ratio
Time frame: Days 4, 7, and 14
S:F ratio
Time frame: Days 4, 7, and 14
Sequential Organ Failure Assessment (SOFA) Score (range 0 [best] to 24 [worst])
Time frame: Days 4, 7, and 14
Time to blood presepsin level
Time frame: Days 0-4
Cumulative incidence of run failures
Time frame: Days 0-1
Cumulative incidence of protocol-specified exempt serious events
Time frame: Days 1-28
Cumulative incidence of grade 3 and 4 clinical and laboratory adverse events
Time frame: Days 1-28
Cumulative incidence of serious adverse events
Time frame: Days 1-28
Cumulative incidence of adverse events of special interest
Time frame: Days 1-28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linzee Mabrey, MD, MsC principal investigator
Unversity of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atibuclimab in people with Acute Respiratory Distress Syndrome and Adult Respiratory Distress Syndrome, 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 9 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 29 Jul 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Contact Linzee Mabrey, MD, MSc ((206) 897-5051, mflinzee@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 4 Oxygenation Index (time frame: Day 1 through Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2026.