[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619985":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":11,"studyPopulation":11,"armGroups":41,"interventions":62,"overallOfficials":11,"centralContacts":71,"locations":77,"responsibleParty":94,"collaborators":11,"id":96,"slug":11,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":11,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":11,"overallStatus":80,"whyStopped":11,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Joincare Pharmaceutical Group Industry Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"The annualized incidence rate of moderate to severe AECOPD",null,"at 24 months",{"measure":14,"description":11,"timeFrame":12},"The duration from the first administration to the first occurrence of moderate to severe AECOPD",[16,19,22,25,28],{"measure":17,"description":11,"timeFrame":18},"trough (pre-bronchodilator) FEV1","at 4, 8, 12 ,16, 20 and 24 weeks",{"measure":20,"description":11,"timeFrame":21},"quality of life（SGRQ score）","at 4, 8,12, 16, 20 and 24 weeks",{"measure":23,"description":11,"timeFrame":24},"quality of life (CAT score)","at 4, 8,12, 16, 20 and 24 months",{"measure":26,"description":11,"timeFrame":27},"The annualized incidence rate of CID","at 24 weeks",{"measure":29,"description":11,"timeFrame":27},"The duration from the first administration to the first occurrence of CID",{"allocation":31,"interventionModel":32,"interventionModelDescription":11,"primaryPurpose":33,"observationalModel":11,"timePerspective":11,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":11,"whoMasked":36},"QUADRUPLE",[37,38,39,40],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[42,48,52,56],{"label":43,"type":44,"description":45,"interventionNames":46},"dose1 of JKN2403 Tablets, once daily orally","EXPERIMENTAL","dose1 of JKN2403 Tablets once daily orally, for 24 weeks",[47],"Drug: JKN2403 Tablets",{"label":49,"type":44,"description":50,"interventionNames":51},"dose2 of JKN2403 Tablets once daily orally","dose2 of JKN2403 Tablets once daily orally, for 24 weeks",[47],{"label":53,"type":44,"description":54,"interventionNames":55},"dose3 of JKN2403 Tablets once daily","dose3 of JKN2403 Tablets once daily orally, for 24 weeks",[47],{"label":57,"type":58,"description":59,"interventionNames":60},"Placebo once daily","PLACEBO_COMPARATOR","Placebo once daily orally, for 24 weeks",[61],"Drug: Placebo",[63,68],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":11},"DRUG","JKN2403 Tablets","JKN2403 Tablets once daily orally, for 24 weeks",[43,49,53],{"type":64,"name":69,"description":69,"armGroupLabels":70,"otherNames":11},"Placebo",[57],[72],{"name":73,"role":74,"phone":75,"phoneExt":11,"email":76},"Weijie Guan Professor","CONTACT","020-81566265","battery203@163.com",[78],{"facility":79,"status":80,"city":81,"state":82,"zip":11,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"The First Affiliated Hospital of Guangzhou Medical University","RECRUITING","Guangzhou","Guangdong","China","CN",{"type":86,"coordinates":87},"Point",[88,89],113.25,23.11667,{"lat":89,"lon":88},[92],{"name":73,"role":74,"phone":93,"phoneExt":11,"email":76},"02081566265",{"type":95,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100619985",false,"NCT07351734","A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial of JKN2403 in COPD","A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of JKN2403 Tablets in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)","COPD","Inclusion Criteria:\n\n* Written informed consent; able and willing to comply with study procedures.\n* Adults with documented COPD diagnosis and medical history consistent with guideline criteria.\n* Relevant exposure history consistent with COPD (e.g., smoking).\n* On stable, guideline-based maintenance COPD therapy prior to randomization, per investigator judgment.\n* Protocol-defined exacerbation history, symptom burden, and lung function at screening.\n\nExclusion Criteria:\n\n* Current or past asthma, or other clinically significant respiratory disease that may confound assessment.\n* Clinically significant uncontrolled comorbidities that increase risk or interfere with participation\u002Foutcomes.\n* Immunodeficiency\u002Fimmune dysregulation, active autoimmune disease requiring systemic immunosuppression, or significant opportunistic infection history.\n* Active clinically significant infection or recent infection requiring systemic therapy; recent protocol-defined COPD exacerbation.\n* Current\u002Frecent malignancy (except low-risk, adequately treated cancers per protocol) or clinically significant abnormal screening labs.\n* Prohibited recent vaccines or therapies, prior relevant biologic\u002Ftargeted therapy exposure, severe hypersensitivity to biologics\u002FIMP, - pregnancy\u002Fbreastfeeding, or inability to comply (including substance abuse), per investigator judgment.","ALL","40 Years","80 Years",{"count":107,"type":108},120,"ESTIMATED","INTERVENTIONAL",[111],"PHASE2","The goal of this clinical trial is to learn if drug JKN2403 works to treat moderate-to-severe COPD in adults. It will also learn about the safety and pharmacokinetic characteristics of drug JKN2403. The main questions it aims to answer are:\n\nDoes drug JKN2403 reduce the incidence of AECOPD or improve the quality of life or alleviate symptoms related to COPD?\n\nResearchers will compare drug JKN2403 to a placebo (a look-alike substance that contains no drug) to see if drug JKN2403 works to treat moderate-to-severe COPD.\n\nParticipants will:\n\nTake drug JKN2403 or a placebo every day for 24 weeks Visit the clinic once every four weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler",[114],"COPD (Chronic Obstructive Pulmonary Disease)","2026-01-10",{"date":117,"type":118},"2026-01-20","ACTUAL",{"date":120,"type":118},"2025-11-06",{"date":122,"type":108},"2026-09-30",{"name":5,"class":6},1]