Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma) (NCT06940141) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)
United States, Argentina, Australia160 participantsStarted 2025-08-08
Plain-language summary
This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation
Who can participate
Age range
12 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Physician-diagnosed asthma with duration of ≥12 months.
* Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication.
* Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids.
* For participants in a stable condition, must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
* Current acute asthma exacerbation requiring an urgent healthcare visit for treatment.
* Peripheral blood eosinophil count of ≥300 cells/µL as part of the assessment of an index acute asthma exacerbation.
* Requires systemic corticosteroid as SoC in the urgent healthcare setting to treat the current acute asthma exacerbation.
* FEV1 ≥30% predicted.
Exclusion Criteria:
* Regular use of immunosuppressive medication.
* Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.
* Current or former smoker, has a smoking history including: If \<30 years old: Smoked for ≥5 pack-years; If ≥30 years old: Smoked for ≥10 pack-years
* COPD and other clinically significant pulmonary disease other than asthma.
* Known or suspected history of immunosuppression.
* History of known immunodeficiency disorder or hepatitis B or C.
* History of alcohol abuse and/or drug abuse.
* Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with cu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing rademikibart as an add-on treatment during an acute asthma attack — what does 'add-on' mean in practice, and would I still be receiving my usual emergency asthma medications if I enrolled?
2Since this is a Phase 2 trial, what do we know so far about the safety of rademikibart, and what side effects should I be prepared to discuss given that the safety profile is still being established at this stage?
3The main thing this trial is measuring is 'treatment failure' within 28 days — can you explain what counts as treatment failure in this context, and what would happen to my care if I experienced that outcome while in the study?
4Because this trial specifically targets acute asthma exacerbations, does participating mean I would need to be enrolled or assessed during a flare-up, and how realistic is that logistically given how suddenly attacks can happen?
5Given that this is still in Phase 2 and focused on a severe, time-sensitive situation like an acute attack, do you think a standard treatment approach might be a safer or more practical first path for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment failure rate within 28 days after randomization