Atibuclimab for ARDS

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called atibuclimab for hospitalized individuals with acute respiratory distress syndrome (ARDS), a severe lung condition. The researchers aim to determine if atibuclimab, a monoclonal antibody, can improve lung function compared to a placebo. Eligible participants must be adults on a ventilator due to ARDS, with contributing factors like pneumonia or inhalation injury. Participants will be monitored for 28 days to track improvements in breathing. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that atibuclimab is likely to be safe for humans?

Research has shown that atibuclimab, also known as IC14, has been safe in earlier studies. In one study with patients who have amyotrophic lateral sclerosis (ALS), atibuclimab was well-tolerated, with no major safety concerns. Another study tested different doses to assess safety and tolerability, and participants managed it well. These findings suggest that atibuclimab could be safe for people, but further research is needed to confirm this for other conditions like acute respiratory distress syndrome (ARDS). ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for Acute Respiratory Distress Syndrome (ARDS), which often includes supportive therapies like mechanical ventilation and corticosteroids, atibuclimab acts on a different target. Atibuclimab is a recombinant monoclonal antibody that specifically targets human CD14, a molecule involved in the body's immune response. This unique mechanism could potentially modulate the immune system more precisely, offering a novel approach to managing the inflammation and lung damage seen in ARDS. Researchers are excited because this targeted action might reduce the severity of ARDS symptoms more effectively and rapidly than current treatments.

What evidence suggests that atibuclimab might be an effective treatment for ARDS?

Research shows that Atibuclimab, also known as IC14, targets a molecule called CD14, which is part of the body's immune system and involved in inflammation. This is crucial for conditions like acute respiratory distress syndrome (ARDS), where inflammation can cause serious lung damage. In this trial, participants will receive either IC14 (atibuclimab) or an identical-appearing placebo. Some patients have improved in their recovery when treated with IC14, but results have varied. Specifically, some studies found that IC14 did not significantly speed up recovery in severe cases, such as those with COVID-19. Overall, while IC14 shows potential, the evidence is mixed, and more research is needed to fully understand its effectiveness for ARDS. ^{1 4 6 7 8}

Who Is on the Research Team?

Linzee Mabrey, MD, MsC

Principal Investigator

Unversity of Washington

Are You a Good Fit for This Trial?

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

Pregnant

Prisoners

History of hypersensitivity or idiosyncratic reaction to IC14

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. epi.washington.edu epi.washington.edu/epi_research/phase-2-randomized-open-label-adaptive-platform-clinical-trial-of-the-clinical-and-biological-effects-of-ic14-treatment-in-patients-with-severe-covid-19/

Phase 2 randomized open label adaptive platform clinical trial ... No significant changes in the primary efficacy analyses were observed following the data audit. IC14 met futility criteria for time-to-recovery and did not meet ...

2. withpower.com withpower.com/trial/phase-2-acute-lung-injuryacute-respiratory-distress-syndrome-ards-7-2024-4af06

Atibuclimab for ARDS · Recruiting Participants for Phase ... This Phase 2 medical study run by Implicit Bioscience is evaluating whether Atibuclimab will have tolerable side effects & efficacy for patients with Acute ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06513949

Anti-CD14 Treatment With IC14 in Hospitalized ARDS ... Hospitalized patients with ARDS will be randomized to intravenous treatment with a monoclonal antibody against CD14, called IC14, or placebo.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10276526/

Phase 2, randomized, double-blind, placebo-controlled multi ... The primary efficacy outcome was the time to resolution of illness as measured by a relative recovery rate within the first 28 days, with ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03017547

A Phase 2 Study of IC14 in Acute Respiratory Distress ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8542123/

Phase 1b dose-escalation, safety, and pharmacokinetic study ... The primary objective was to demonstrate the safety and tolerability of monoclonal antibody against CD14 (IC14) (atibuclimab) in amyotrophic ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/mus.27775

Safety and activity of anti‐CD14 antibody IC14 (atibuclimab ... A previous phase 1 trial of 10 participants with amyotrophic lateral sclerosis (ALS) demonstrated initial safety of IC14 in an acute treatment ...

8. synapse.patsnap.com synapse.patsnap.com/drug/15650b29ef23456eab2175ee9f2b914c

Atibuclimab - Drug Targets, Indications, Patents Results: IC14 treatment did not improve time-to-recovery or 28-day mortality in the overall population, and the trial was stopped due to meeting futility ...