[{"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:":53},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"100647067","phase-2-rademikibart-iv-for-acute-asthma-and-copd-exacerbation-100647067",false,"NCT07705737","Rademikibart IV for Acute Asthma and COPD Exacerbation","A Phase 2, Open-Label, Single-Arm Trial to Evaluate IV Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Asthma and or COPD With Type 2 Inflammation","Inclusion Criteria - Asthma cohort\n\n* Body weight of ≥40 kg and BMI ≤45 kg\u002Fm2 at SV1a.\n* Physician-diagnosed asthma\n* Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication.\n* Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids.\n* Participants in a stable condition, must have a historical peripheral blood eosinophil count of ≥250 cells\u002FμL and\u002For FeNO ≥ 25 ppb.\n* Current acute asthma exacerbation requiring an urgent healthcare visit for treatment.\n* Peripheral blood eosinophil count of ≥300 cells\u002FµL as part of the assessment of an index acute asthma exacerbation.\n* Requires systemic corticosteroid as SoC in the urgent healthcare setting to treat the current acute asthma exacerbation.\n* FEV1 ≥30% predicted.\n\nExclusion Criteria - Asthma cohort\n\n* Regular use of immunosuppressive medication.\n* Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.\n* Current or former smoker, with a smoking history of ≥5 pack-years if \\\u003C30 years old or ≥10 pack-years if ≥30 years old\n* COPD and other clinically significant pulmonary disease other than asthma.\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 or other malignancies treated with apparent success with curative therapy.\n* Female participant who is pregnant, lactating or breast-feeding.\n* Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines.\n* Recent receipt of any marketed biologic drug or any investigational biologic for asthma or other diseases.\n* Recent live, attenuated vaccinations or planned live, attenuated vaccinations during the trial.\n* Participants that have been recently treated with bronchial thermoplasty.\n* Recent receipt of any investigational nonbiologic drug.\n* A recent chest X-ray or computed tomography with findings that are inconsistent for an asthmatic population.\n\nInclusion Criteria - COPD cohort\n\n* Body weight of ≥45 kg and BMI ≤45 kg\u002Fm2\n* Physician-diagnosed COPD\n* Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids.\n* Participants in a stable condition must have a 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 - COPD cohort\n\n* Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to approximately 12 weeks or 5 half-lives, 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, 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 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 scan reveals evidence of clinically significant abnormalities or pulmonary infection.\n* Female participant who is pregnant, lactating or breast-feeding.\n* Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to SV1b, whichever is longer.\n* Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives, whichever is longer.\n* Live, attenuated vaccinations within 4 weeks prior to screening or planned live, attenuated vaccinations during the trial.\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","18 Years","85 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","A Phase 2, open-label, single-arm trial to evaluate IV rademikibart as an add-on treatment for acute exacerbation in participants with asthma or COPD with type 2 inflammation",[27,28],"Asthma Acute","COPD Exacerbation Acute",[30,31,32,33,34,35,36,37,38,39,40],"Acute exacerbation","Asthma","Asthma exacerbation","CBP-201","Rademikibart","Connect Biopharma","COPD exacerbation","COPD acute","COPD","COPD flare","Asthma attack","NOT_YET_RECRUITING","2026-07-10",{"date":44,"type":45},"2026-07-15","ACTUAL",{"date":47,"type":21},"2026-07-30",{"date":49,"type":21},"2027-01",{"name":51,"class":52},"Connect Biopharm LLC","INDUSTRY",""]