rademikibart add-on treatment of an acute copd exacerbation (seabreeze stat copd)

Conditions: COPD Acute Exacerbation

Summary: this is a phase 2, multicenter study in adult participants with an acute copd exacerbation and type 2 inflammation

this is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, interventional trial in participants with an acute copd exacerbation with type 2 inflammation in the urgent healthcare setting to compare rademikibart plus standard therapy to standard therapy (plus placebo).

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 (oral or parenteral) within the previous 12 months prior to screening. * participants who consent to participate in the trial while in a stable condition must have a documented historical peripheral blood eosinophil count of ≥250 cells/μl within 12 months prior to screening visit 1a. * 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 cerebrovascular event \<6 months from screening visit. * known or suspected history of immunosuppression. * history of known immunodeficiency disorder (including human immunodeficiency virus \[hiv\]-1 or hiv-2). known medical history of hepatitis b or c. * history of alcohol abuse and/or drug abuse within 12 months prior to screening. * 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. * 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) at screening visit 1b. * 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 oral corticosteroids 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.

Keywords: copd chronic obstructive pulmonary disease rademikibart connect biopharma cbp-201 copd exacerbation type 2 inflammation