[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"moderate-to-severe-chronic-obstructive-pulmonary-disease-copd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:moderate-to-severe-chronic-obstructive-pulmonary-disease-copd":27},{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100623893","phase-2-phase-ii-study-of-rc1416-injection-in-copd-100623893",false,"NCT07402551","Phase II Study of RC1416 Injection in COPD","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of RC1416 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)","Inclusion Criteria:\n\n* Aged 40 to 85 years (inclusive) at the time of signing the informed consent form, regardless of gender.\n* Body Mass Index (BMI) ≥ 16 kg\u002Fm².\n* Meets the diagnostic criteria for chronic obstructive pulmonary disease (COPD), and has medical records or relevant documentation indicating a history of COPD for ≥ 12 months at screening.\n* Post-bronchodilator ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) \\\u003C 0.7, and post-bronchodilator FEV1 ≥ 30% and \\\u003C 80% of the predicted value at screening.\n* A current smoker or former smoker with a smoking history of ≥ 10 pack-years, or a history of exposure to other risk factors.\n* A score of ≥ 2 on the modified Medical Research Council (mMRC) dyspnea scale at screening.\n* Medical records or relevant documentation showing ≥ 2 moderate COPD. exacerbations (AECOPD) or ≥ 1 severe AECOPD within the 12 months prior to screening.\n* Medical records or relevant documentation showing receipt of background triple therapy (ICS + LABA + LAMA) for ≥ 3 months prior to randomization.\n* A blood eosinophil count ≥ 150\u002Fmm³ (0.15×10⁹\u002FL) at screening.\n\nExclusion Criteria:\n\n* A current diagnosis of asthma or a history of asthma.\n* Presence of other significant pulmonary diseases except COPD as judged by the Investigator.\n* History of malignancy .\n* A history of autoimmune diseases , or treatment with biologics or systemic immunosuppressants for inflammatory diseases within 8 weeks or 5 half-lives (whichever is longer) prior to signing the informed consent form.\n* Presence of recurrent, chronic, or other active infections at screening.\n* Currently receiving or planning to start long-term oxygen therapy or mechanical ventilation during the study period.\n* Diagnosis of α1-antitrypsin deficiency.\n* Active hepatitis B, active hepatitis C, positive human immunodeficiency virus (HIV) antibody, or positive Treponema pallidum antibody (TP-Ab).\n* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","ALL","40 Years","85 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of RC1416 injection in patients with moderate to severe chronic obstructive pulmonary disease (COPD).",[27],"Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)","RECRUITING","2026-04-14",{"date":31,"type":32},"2026-04-17","ACTUAL",{"date":34,"type":32},"2026-03-06",{"date":36,"type":21},"2028-08-30",{"name":38,"class":39},"Nanjing RegeneCore Biotech Co., Ltd.","INDUSTRY",41]