NCT06940154
Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
Active, Not Recruiting
PHASE2Ages 40–80InterventionalTreatmentConnect Biopharm LLC
~160 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Rademikibart in prefilled syringeMatching placebo in prefilled syringe
At a glance
Recruiting sites
0 of 52 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment failure rate
Measured over 28 days
Conditions
Where it's being run
52 sites across 27 statesGeorgia8
Buenos Aires5
Serbia5
United Kingdom4
Florida3
Texas3
New South Wales3
California2
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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 cerebrovascular event \<6 months from Screening Visit.
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.
Chronic treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for \>15 hours a day.
Participants on long-term macrolide.
Current acute COPD exacerbation for which SoC was started \>48 hours prior to Screening.
A recent chest X-ray or computed tomography (CT) scan at Screening reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD, or a clinically significant pulmonary infection identified by chest X-ray (CT scan).
Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β-hCG test prior to randomization.
Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to randomization, whichever is longer.
Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives prior to randomization, whichever is longer.
Live, attenuated vaccinations within 4 weeks prior to randomization or planned live, attenuated vaccinations during the trial.
Treatment with systemic corticosteroids (ie, oral or by injection) and/or hospitalization for an exacerbation of COPD completed less than 4 weeks prior to randomization.
What this trial measures
- Treatment failure rate28 days
Treatment failure is defined as death due to any cause, (re)admission to a hospital for COPD, ED (re)visit or unscheduled medical visit for worsening of COPD symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for COPD exacerbation) within 28 days after randomization.