Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD) (NCT06940154) | Clinical Trial Compass
RecruitingPhase 2
Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
United States160 participantsStarted 2025-08-12
Plain-language summary
This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion Criteria:
* Physician-diagnosed COPD with duration of ≥12 months.
* Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids.
* Participants in a stable condition must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
* Current or former smoker with a history of smoking of ≥10 pack-years.
* Current acute COPD exacerbation requiring an urgent healthcare visit for treatment.
* Peripheral blood eosinophil count of ≥300 cells/μL as part of the assessment of the index acute COPD exacerbation.
* Requires systemic corticosteroids as standard of care treatment in the urgent healthcare setting for the current acute COPD exacerbation.
Exclusion Criteria:
* Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer.
* Current diagnosis or a history of asthma, according to the Global Initiative for Asthma; or participants with a current diagnosis or history of Asthma COPD Overlap Syndrome.
* Other respiratory disorders that might compromise the safety of the participant or affect the interpretation of the results.
* Unstable ischemic heart disease, cardiomyopathy, heart failure (New York Heart Association Class III or IV), uncontrolled hypertension. Cardiac arrhythmias including paroxysmal atrial fibrillation.
* Transient ischemic attack or stroke \<6 months from Screening Visit; hospitalization for any cardiovascular or cerebrovas…