Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Chronic Obstructive Pulmonary Disease and Type 2 Inflammation
This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation
Eligibility
Min Age: 40 YearsMax Age: 80 Years
Plain Language Summary
Simplified for easier understanding
This study is testing whether rademikibart — a new biologic that blocks a key part of the inflammatory pathway — can help patients who are in the emergency setting with an acute COPD flare-up. COPD (chronic obstructive pulmonary disease) is a chronic lung condition that makes breathing difficult. The drug is being tested as an add-on to standard steroid treatment during a flare.
**You may be eligible if...**
- You have been diagnosed with COPD for at least 12 months
- You are a current or former smoker with a smoking history of at least 10 pack-years
- You are currently having an acute COPD flare-up requiring urgent medical care and systemic steroids
- Your blood eosinophil count is 300 or more per microliter during this acute visit
- You have had at least one prior COPD flare-up requiring steroids
**You may NOT be eligible if...**
- You have asthma or an overlap condition between asthma and COPD
- You have significant heart disease (unstable angina, heart failure Class III/IV, uncontrolled hypertension, arrhythmias)
- You have had a stroke or heart event in the last 6 months
- You have other significant respiratory conditions that could affect the study results
- You are on immunosuppressive medications
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
COMBINATION_PRODUCTRademikibart in prefilled syringe
Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
DRUGMatching placebo in prefilled syringe
Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
Locations(51)
University of Alabama at Birmingham Lung Health Center