[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06940154":3,"trial-entities:NCT06940154":479,"trial-summary:NCT06940154":487},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":49,"secondary_outcomes":54,"sex":77,"minimum_age":78,"maximum_age":79,"healthy_volunteers":80,"eligibility_criteria":81,"std_ages":110,"locations":113,"central_contacts":475,"overall_officials":476,"references":477,"see_also_links":478},"NCT06940154","CBP-201-207","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","ACTIVE_NOT_RECRUITING","2026-08-27","2026-07","2026-07-13","2025-08-12","Connect Biopharm LLC","INDUSTRY",true,"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).",[19],"COPD Acute Exacerbation",[21,22,23,24,25,26,27],"COPD","chronic obstructive pulmonary disease","rademikibart","Connect Biopharma","CBP-201","COPD exacerbation","type 2 inflammation","INTERVENTIONAL","TREATMENT",[31],"PHASE2",{"count":33,"type":34},160,"ESTIMATED",[36,43],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":42},"COMBINATION_PRODUCT","Rademikibart in prefilled syringe","Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.",[41],"Rademikibart",[25],{"type":44,"name":45,"description":46,"armGroupLabels":47},"DRUG","Matching placebo in prefilled syringe","Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.",[48],"Placebo",[50],{"measure":51,"description":52,"timeFrame":53},"Treatment failure rate","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.","28 days",[55,58,60,62,66,70,73,75],{"measure":56,"timeFrame":57},"Absolute change from baseline (CFB) in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 1","Week 1",{"measure":59,"timeFrame":53},"Rate of new moderate and severe COPD exacerbations over the 28 days after randomization",{"measure":61,"timeFrame":53},"Time to the first new moderate or severe COPD exacerbation in the 28 days after randomization",{"measure":63,"description":64,"timeFrame":65},"Mean CFB in EXACT-PRO score","Mean CFB in clinical respiratory symptoms of COPD using the E-RS: COPD (Evaluating Respiratory Symptoms in COPD) comprised in the EXACT-PRO through Week 1, Week 2, and Week 4. The Exacerbations of Chronic Pulmonary Disease Tool - Patient-Reported Outcome (EXACT-PRO) is a PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in patients with COPD.","Week 1, Week 2, and Week 4",{"measure":67,"description":68,"timeFrame":69},"Absolute CFB in post-BD FEV1 at Day 3 and Week 4","Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Day 3, Week 1, and Week 4","Day 3, Week 1, and Week 4",{"measure":71,"timeFrame":72},"Incidence of adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESIs), and drug-induced liver injury (DILI) reported","56 days",{"measure":74,"timeFrame":72},"Incidence of unanticipated adverse device effects (UADEs)",{"measure":76,"timeFrame":72},"Incidence of injection site reactions","ALL","40 Years","80 Years",false,{"inclusion":82,"exclusion":90,"raw_text":109},[83,84,85,86,87,88,89],"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\u002FμL and\u002For 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\u002FμL 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.",[91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108],"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 \\\u003C6 months from Screening Visit; hospitalization for any cardiovascular or cerebrovascular event \\\u003C6 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\u002For 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\u002For hospitalization for an exacerbation of COPD completed less than 4 weeks prior to randomization.","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.",[111,112],"ADULT","OLDER_ADULT",[114,123,131,138,146,154,158,165,173,180,188,196,204,212,220,228,236,244,251,258,266,274,280,286,293,297,304,312,320,327,336,344,351,358,366,374,382,389,393,397,400,403,406,414,421,428,435,442,451,457,461,468],{"facility":115,"city":116,"state":117,"zip":118,"country":119,"geoPoint":120},"University of Alabama at Birmingham Lung Health Center","Birmingham","Alabama","35233","United States",{"lat":121,"lon":122},33.52066,-86.80249,{"facility":124,"city":125,"state":126,"zip":127,"country":119,"geoPoint":128},"Leland Stanford Junior University, Stanford Hospital","Palo Alto","California","94304",{"lat":129,"lon":130},37.44188,-122.14302,{"facility":132,"city":133,"state":126,"zip":134,"country":119,"geoPoint":135},"Amicis Research Center","Valencia","91355",{"lat":136,"lon":137},34.44361,-118.60953,{"facility":139,"city":140,"state":141,"zip":142,"country":119,"geoPoint":143},"National Jewish Health","Denver","Colorado","80206",{"lat":144,"lon":145},39.73915,-104.9847,{"facility":147,"city":148,"state":149,"zip":150,"country":119,"geoPoint":151},"Columbus Clinical Services, LLC","Miami","Florida","33125",{"lat":152,"lon":153},25.77427,-80.19366,{"facility":155,"city":148,"state":149,"zip":156,"country":119,"geoPoint":157},"Pharmax Research of South Florida, Inc.","33175",{"lat":152,"lon":153},{"facility":159,"city":160,"state":149,"zip":161,"country":119,"geoPoint":162},"Health Synergy Clinical Research, LLC","West Palm Beach","33407",{"lat":163,"lon":164},26.71534,-80.05337,{"facility":166,"city":167,"state":168,"zip":169,"country":119,"geoPoint":170},"Primeway Clinical Research Group","Fayetteville","Georgia","30214",{"lat":171,"lon":172},33.44873,-84.45493,{"facility":174,"city":175,"state":168,"zip":176,"country":119,"geoPoint":177},"Pivotal Research Solutions","Stonecrest","30038",{"lat":178,"lon":179},33.70849,-84.13485,{"facility":181,"city":182,"state":183,"zip":184,"country":119,"geoPoint":185},"University of Iowa","Iowa City","Iowa","52242",{"lat":186,"lon":187},41.66113,-91.53017,{"facility":189,"city":190,"state":191,"zip":192,"country":119,"geoPoint":193},"University of Kansas Medical Center","Kansas City","Kansas","66160",{"lat":194,"lon":195},39.11417,-94.62746,{"facility":197,"city":198,"state":199,"zip":200,"country":119,"geoPoint":201},"Ochsner Medical Complex - The Grove","Baton Rouge","Louisiana","70836",{"lat":202,"lon":203},30.44332,-91.18747,{"facility":205,"city":206,"state":207,"zip":208,"country":119,"geoPoint":209},"Stony Brook University Hospital","Stony Brook","New York","11733",{"lat":210,"lon":211},40.92565,-73.14094,{"facility":213,"city":214,"state":215,"zip":216,"country":119,"geoPoint":217},"Duke Asthma, Allergy, and Airway Center","Durham","North Carolina","27705",{"lat":218,"lon":219},35.99403,-78.89862,{"facility":221,"city":222,"state":223,"zip":224,"country":119,"geoPoint":225},"The Ohio State University Wexner Medical Center","Columbus","Ohio","43210",{"lat":226,"lon":227},39.96118,-82.99879,{"facility":229,"city":230,"state":231,"zip":232,"country":119,"geoPoint":233},"Clinical Research of Rock Hill","Rock Hill","South Carolina","29732",{"lat":234,"lon":235},34.92487,-81.02508,{"facility":237,"city":238,"state":239,"zip":240,"country":119,"geoPoint":241},"Inquest Clinical Research","Baytown","Texas","77521",{"lat":242,"lon":243},29.7355,-94.97743,{"facility":245,"city":246,"state":239,"zip":247,"country":119,"geoPoint":248},"Premier Pulmonary Critical Care and Sleep Medicine","Denison","75020",{"lat":249,"lon":250},33.75566,-96.53666,{"facility":252,"city":253,"state":239,"zip":254,"country":119,"geoPoint":255},"DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials","McAllen","78503",{"lat":256,"lon":257},26.20341,-98.23001,{"facility":259,"city":260,"state":261,"zip":262,"country":119,"geoPoint":263},"Vermont Lung Center","Colchester","Vermont","05446",{"lat":264,"lon":265},44.54394,-73.14791,{"facility":267,"city":268,"state":269,"zip":270,"country":119,"geoPoint":271},"Carilion Medical Center \u002F Carilion Roanoke Memorial Hospital","Roanoke","Virginia","24014",{"lat":272,"lon":273},37.27097,-79.94143,{"facility":275,"city":276,"state":277,"zip":278,"country":279},"Hospital Italiano de Buenos Aires","CABA","Buenos Aires","C1199","Argentina",{"facility":281,"city":149,"state":277,"zip":282,"country":279,"geoPoint":283},"CEMER - Centro Medico de Enfermedades Respiratorias","B1602",{"lat":284,"lon":285},-34.53258,-58.49078,{"facility":287,"city":288,"state":277,"zip":289,"country":279,"geoPoint":290},"Instituto Ave Pulmo-Fundacion Enfisema","Mar del Plata","7600",{"lat":291,"lon":292},-38.00042,-57.5562,{"facility":294,"city":288,"state":277,"zip":295,"country":279,"geoPoint":296},"Centro de Investigaciones Médicas Mar del Plata","B7600FYK",{"lat":291,"lon":292},{"facility":298,"city":299,"state":277,"zip":300,"country":279,"geoPoint":301},"Hospital Universitario Austral","Pilar","1629",{"lat":302,"lon":303},-34.45867,-58.91398,{"facility":305,"city":306,"state":307,"zip":308,"country":279,"geoPoint":309},"Centro Medico Ipam S.A","Rosario","Santa Fe Province","S2000",{"lat":310,"lon":311},-32.94682,-60.63932,{"facility":313,"city":314,"state":315,"zip":316,"country":279,"geoPoint":317},"Investigaciones en Patologias Respiratorias SRL","San Miguel de Tucumán","Tucumán Province","4000",{"lat":318,"lon":319},-26.81601,-65.21051,{"facility":321,"city":322,"zip":323,"country":279,"geoPoint":324},"Centro de Diagnostivo y Rehabilitación S.A. - CEDIR","Santa Fe","S3000",{"lat":325,"lon":326},-31.64881,-60.70868,{"facility":328,"city":329,"state":330,"zip":331,"country":332,"geoPoint":333},"The Canberra Hospital","Garran","Australian Capital Territory","2605","Australia",{"lat":334,"lon":335},-35.34206,149.10846,{"facility":337,"city":338,"state":339,"zip":340,"country":332,"geoPoint":341},"Campbelltown Hospital","Campbelltown","New South Wales","2560",{"lat":342,"lon":343},-34.06667,150.81667,{"facility":345,"city":346,"state":339,"zip":347,"country":332,"geoPoint":348},"St. Vincent's Hospital Sydney","Darlinghurst","2010",{"lat":349,"lon":350},-33.87939,151.21925,{"facility":352,"city":353,"state":339,"zip":354,"country":332,"geoPoint":355},"Westmead Hospital","Westmead","2145",{"lat":356,"lon":357},-33.80383,150.98768,{"facility":359,"city":360,"state":361,"zip":362,"country":332,"geoPoint":363},"Sunshine Coast University Hospital","Birtinya","Queensland","4575",{"lat":364,"lon":365},-26.74322,153.11913,{"facility":367,"city":368,"state":369,"zip":370,"country":332,"geoPoint":371},"Bendigo Health","Bendigo","Victoria","3550",{"lat":372,"lon":373},-36.75818,144.28024,{"facility":375,"city":376,"state":377,"zip":378,"country":332,"geoPoint":379},"Institute for Respiratory Health","Nedlands","Western Australia","6009",{"lat":380,"lon":381},-31.98184,115.8073,{"facility":383,"city":384,"zip":385,"country":168,"geoPoint":386},"JSC \"National Center for Lung Health\"","Tbilisi","0101",{"lat":387,"lon":388},41.69143,44.83412,{"facility":390,"city":384,"zip":391,"country":168,"geoPoint":392},"LLC \"Israel-Georgian Medical Research Clinic Healthycore\"","0112",{"lat":387,"lon":388},{"facility":394,"city":384,"zip":395,"country":168,"geoPoint":396},"Acad. Chapidze Emergency Cardiology Center LLC","0159",{"lat":387,"lon":388},{"facility":398,"city":384,"zip":395,"country":168,"geoPoint":399},"Acad. G. Chapidze Emergency Cardiology Center",{"lat":387,"lon":388},{"facility":401,"city":384,"zip":395,"country":168,"geoPoint":402},"Caucasus Medical Center",{"lat":387,"lon":388},{"facility":404,"city":384,"zip":395,"country":168,"geoPoint":405},"LLC Diacor",{"lat":387,"lon":388},{"facility":407,"city":408,"zip":409,"country":410,"geoPoint":411},"Clinical Hospital Center \"Dragisa Misovic - Dedinje\"","Belgrade","11040","Serbia",{"lat":412,"lon":413},44.80401,20.46513,{"facility":415,"city":416,"zip":417,"country":410,"geoPoint":418},"Institute for Pulmonary Diseases of Vojvodina","Kamenitz","21204",{"lat":419,"lon":420},45.22334,19.84263,{"facility":422,"city":423,"zip":424,"country":410,"geoPoint":425},"University Clinical Center Kragujevac","Kragujevac","34000",{"lat":426,"lon":427},44.01667,20.91667,{"facility":429,"city":430,"zip":431,"country":410,"geoPoint":432},"Institute for Pulmonary Diseases and Tuberculosis Nis","Niš","18108",{"lat":433,"lon":434},43.32472,21.90333,{"facility":436,"city":437,"zip":438,"country":410,"geoPoint":439},"Health Center Uzice","Užice","31000",{"lat":440,"lon":441},43.85861,19.84878,{"facility":443,"city":444,"state":445,"zip":446,"country":447,"geoPoint":448},"Medicines Evaluation Unit Ltd.","Wythenshawe","Greater Manchester","M23 9QZ","United Kingdom",{"lat":449,"lon":450},53.38027,-2.2654,{"facility":452,"city":116,"zip":453,"country":447,"geoPoint":454},"Queen Elizabeth hospital Birmingham","B15 2GW",{"lat":455,"lon":456},52.48142,-1.89983,{"facility":458,"city":116,"zip":459,"country":447,"geoPoint":460},"University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands Hospital","B9 5SS",{"lat":455,"lon":456},{"facility":462,"city":463,"zip":464,"country":447,"geoPoint":465},"Guy's and St Thomas NHS Foundation Trust","London","SE1 7EH",{"lat":466,"lon":467},51.50853,-0.12574,{"facility":469,"city":470,"zip":471,"country":447,"geoPoint":472},"Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research Facility","Salford","M6 8HD",{"lat":473,"lon":474},53.48771,-2.29042,[],[],[],[],{"nct_id":4,"conditions":480,"biomarkers":483},[481,482],"Chronic Obstructive Pulmonary Disease","Chronic Obstructive Pulmonary Disease with Acute Exacerbation",[484,485,486],"Eosinophil Count","IL-4Rα","TNFRSF11A wt Allele",{"nct_id":4,"found":80,"summary":488,"prompt_version":488},null]