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Monoclonal Antibodies

Atibuclimab for ARDS

Phase 2
Waitlist Available
Led By Linzee Mabrey, MD, MsC
Research Sponsored by Implicit Bioscience
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Respiratory failure not fully explained by cardiac failure or fluid overload
Patient or Legal authorized representative able to understand and give written informed consent
Must not have
Receiving comfort measures only
Requiring >2 vasopressors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 4, 7, and 14
Awards & highlights

Summary

This trial will test a new treatment for patients with acute respiratory distress syndrome (ARDS) in the hospital. Patients will receive either a new medication called IC14 or a placebo through an IV. They will

Who is the study for?
This trial is for hospitalized patients with ARDS, a severe lung condition often caused by infection or injury. Participants must meet specific health criteria to be eligible.
What is being tested?
The study tests IC14, an antibody treatment against CD14 in the blood, versus a placebo. Patients are randomly assigned to one of these treatments and monitored for oxygen levels over 28 days.
What are the potential side effects?
Potential side effects of IC14 may include allergic reactions, infusion-related symptoms like fever or chills, and possible impact on immune response due to its action on the body's cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breathing issues are not due to heart problems or fluid in my body.
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I can understand and sign the consent form myself or have someone who can legally do it for me.
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My breathing support is set to a pressure of 5 cm H2O or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am only receiving treatment to ease symptoms.
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I need more than two medications to manage my blood pressure.
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I have an active infection such as HIV, TB, hepatitis B, or C.
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I do not have severe lung, heart, brain conditions, or need for significant life support that would make a lung exam unsafe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 4, 7, and 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 4, 7, and 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Day 4 Oxygenation Index
Secondary study objectives
Biomarkers of injury and inflammation measured in bronchoalveolar lavage fluid
Biomarkers of injury and inflammation measured in plasma
Cumulative incidence of adverse events of special interest
+10 more
Other study objectives
Mortality
Ventilator-free Days

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IC14 (atibuclimab)Experimental Treatment1 Intervention
IC14 (atibuclimab) is a recombinant monoclonal antibody against human CD14
Group II: Identical-appearing placeboPlacebo Group1 Intervention
Sterile normal saline

Find a Location

Who is running the clinical trial?

Implicit BioscienceLead Sponsor
10 Previous Clinical Trials
74 Total Patients Enrolled
University of WashingtonOTHER
1,791 Previous Clinical Trials
1,905,450 Total Patients Enrolled
Linzee Mabrey, MD, MsCPrincipal InvestigatorUnversity of Washington
~37 spots leftby Feb 2025
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