Atibuclimab for ARDS

Overseen By Linzee Mabrey, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Implicit Bioscience

Must not be taking: Immunosuppressants, Immunomodulatory

Disqualifiers: Organ dysfunction, Co-existing infection, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 days

56 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial requires that you have not been treated with certain immunosuppressant or immunomodulatory drugs within 30 days or five half-lives, whichever is longer. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

How is the drug Atibuclimab unique in treating ARDS?

Atibuclimab is unique because it targets CD14, a molecule involved in the body's immune response, which is different from other treatments that often target tumor necrosis factor (TNF) or programmed death ligand-1 (PD-L1). This novel approach may offer a different mechanism to manage the inflammation associated with ARDS. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Linzee Mabrey, MD, MsC

Principal Investigator

Unversity of Washington

Eligibility Criteria

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.

Inclusion Criteria

P:F ratio < 300

I have a condition like pneumonia or major trauma that increases my risk for ARDS.

My breathing issues are not due to heart problems or fluid in my body.

Exclusion Criteria

I am only receiving treatment to ease symptoms.

Pregnant

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intravenous treatment with IC14 or placebo

4 days

Daily visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

Regular monitoring visits

Treatment Details

Interventions

• Atibuclimab

Trial Overview 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.

Participant Groups

Group I: IC14 (atibuclimab) Experimental Treatment 1 Intervention

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

Group II: Identical-appearing placebo Placebo Group 1 Intervention

Sterile normal saline

Atibuclimab is already approved in United States for the following indications:

Approved in United States as Atibuclimab for:

• Acute Decompensated Heart Failure (clinical trial phase, not yet approved)

Who Is Running the Clinical Trial?

Implicit Bioscience

Lead Sponsor

Trials

12

Recruited

140+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Differences in binding and effector functions between classes of TNF antagonists. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Intratumoral Combinatorial Administration of CD1c (BDCA-1)+ Myeloid Dendritic Cells Plus Ipilimumab and Avelumab in Combination with Intravenous Low-Dose Nivolumab in Patients with Advanced Solid Tumors: A Phase IB Clinical Trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Avelumab: search for combinations of immune checkpoint inhibition with chemotherapy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

An Engineered Monovalent Anti-TNF-α Antibody with pH-Sensitive Binding Abrogates Immunogenicity in Mice following a Single Intravenous Dose. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Immunogenicity of immunomodulatory, antibody-based, oncology therapeutics. [2020]