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Completed NCT06940154

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

Conditions: COPD Acute Exacerbation

Sex: All
Ages: 40 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 159
Sponsor: Connect Biopharm LLC

Location: University of Alabama at Birmingham Lung Health Center Birmingham Alabama

Summary

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

Eligibility Criteria

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 \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. The above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06940154). StuddyBuddy aggregates publicly available trial information.