[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647067":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":21,"locations":27,"responsibleParty":43,"collaborators":11,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":11,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":75,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Connect Biopharm LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Rademikibart","EXPERIMENTAL",null,[13],"Drug: Rademikibart",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Single 300 mg dose as a 2-minute IV push",[9],[20],"CBP-201",[22],{"name":23,"role":24,"phone":25,"phoneExt":11,"email":26},"Radha Adivikolanu","CONTACT","213-522-7990","clinical209@connectpharm.com",[28],{"facility":29,"status":11,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Columbus Clinical Services, LLC","Miami","Florida","33135","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-80.19366,25.77427,{"lat":39,"lon":38},[42],{"name":23,"role":24,"phone":25,"phoneExt":11,"email":26},{"type":44,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":56,"type":57},40,"ESTIMATED","INTERVENTIONAL",[60],"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",[63,64],"Asthma Acute","COPD Exacerbation Acute",[66,67,68,20,9,69,70,71,72,73,74],"Acute exacerbation","Asthma","Asthma exacerbation","Connect Biopharma","COPD exacerbation","COPD acute","COPD","COPD flare","Asthma attack","NOT_YET_RECRUITING","2026-07-10",{"date":78,"type":79},"2026-07-15","ACTUAL",{"date":81,"type":57},"2026-07-30",{"date":83,"type":57},"2027-01",{"name":5,"class":6},1]