[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Connect Biopharm LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100588342",false,"NCT06940154","Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)","A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Chronic Obstructive Pulmonary Disease and Type 2 Inflammation","Inclusion Criteria:\n\n* Physician-diagnosed COPD with duration of ≥12 months.\n* Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids.\n* Participants in a stable condition must have a documented historical peripheral blood eosinophil count of ≥250 cells\u002FμL and\u002For FeNO ≥ 25 ppb.\n* Current or former smoker with a history of smoking of ≥10 pack-years.\n* Current acute COPD exacerbation requiring an urgent healthcare visit for treatment.\n* Peripheral blood eosinophil count of ≥300 cells\u002FμL as part of the assessment of the index acute COPD exacerbation.\n* Requires systemic corticosteroids as standard of care treatment in the urgent healthcare setting for the current acute COPD exacerbation.\n\nExclusion Criteria:\n\n* Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer.\n* 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.\n* Other respiratory disorders that might compromise the safety of the participant or affect the interpretation of the results.\n* Unstable ischemic heart disease, cardiomyopathy, heart failure (New York Heart Association Class III or IV), uncontrolled hypertension. Cardiac arrhythmias including paroxysmal atrial fibrillation.\n* Transient ischemic attack or stroke \\\u003C6 months from Screening Visit; hospitalization for any cardiovascular or cerebrovascular event \\\u003C6 months from Screening Visit.\n* Known or suspected history of immunosuppression.\n* History of known immunodeficiency disorder or hepatitis B or C.\n* History of alcohol abuse and\u002For drug abuse.\n* Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success.\n* Chronic treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for \\>15 hours a day.\n* Participants on long-term macrolide.\n* Current acute COPD exacerbation for which SoC was started \\>48 hours prior to Screening.\n* 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).\n* Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β-hCG test prior to randomization.\n* Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to randomization, whichever is longer.\n* 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.\n* Live, attenuated vaccinations within 4 weeks prior to randomization or planned live, attenuated vaccinations during the trial.\n* Treatment with systemic corticosteroids (ie, oral or by injection) and\u002For hospitalization for an exacerbation of COPD completed less than 4 weeks prior to randomization.\n\nThe above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","ALL","40 Years","80 Years",{"count":19,"type":20},160,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation",[26],"COPD Acute Exacerbation",[28,29,30,31,32,33,34],"COPD","chronic obstructive pulmonary disease","rademikibart","Connect Biopharma","CBP-201","COPD exacerbation","type 2 inflammation","RECRUITING","2026-06-10",{"date":38,"type":39},"2026-06-12","ACTUAL",{"date":41,"type":39},"2025-08-12",{"date":43,"type":20},"2026-07",{"name":45,"class":46},"Connect Biopharm LLC","INDUSTRY",53,""]