Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)
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 Adult and Adolescent Participants With Asthma and Type 2 Inflammation
This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation
Eligibility
Min Age: 12 YearsMax Age: 75 Years
Plain Language Summary
Simplified for easier understanding
This study is testing whether rademikibart — a new injectable biologic medication that targets a protein involved in airway inflammation — can help patients who come to the emergency department or urgent care during a severe asthma flare-up. It is being added on top of standard steroid treatment to see if it speeds recovery and reduces the chance of another attack.
**You may be eligible if...**
- You have been diagnosed with asthma for at least 12 months
- You are currently having an acute asthma flare-up requiring urgent medical care
- You are on inhaled corticosteroids (ICS) plus at least one other asthma controller medication
- Your blood shows high eosinophil levels (a type of immune cell linked to allergic asthma) of 300 or more per microliter during this acute visit
- You have had at least one prior asthma flare-up requiring steroids
**You may NOT be eligible if...**
- You are on regular immunosuppressive medications
- You have significant heart disease or uncontrolled high blood pressure
- You are a heavy smoker (10+ pack-years if age 30+; 5+ pack-years if under 30)
- You have COPD or other significant lung disease besides asthma
- You have a history of HIV or hepatitis B or C
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.