RecruitingCOPD Acute Exacerbation

Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)

Eligible age

40–80 yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation

Sponsor: Connect Biopharm LLC

✓ 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.

✕ 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.