[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"systemic-sclerosis-associated-interstitial-lung-disease-ssc-ild\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:systemic-sclerosis-associated-interstitial-lung-disease-ssc-ild":46},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100530646","phase-2-a-randomized-double-blind-placebo-controlled-phase-ii-clinical-study-to-evaluate-the-safety-tolerability-efficacy-and-pharmacokinetic-profile-of-genakumab-injection-in-patients-with-connective-tissue-disease-associated-interstitial-lung-disease-100530646",false,"NCT06189495","A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic Profile of Genakumab Injection in Patients With Connective Tissue Disease-associated Interstitial Lung Disease","Inclusion Criteria:\n\n1. Those who voluntarily sign informed consent and can complete the experiment according to the plan;\n2. Age 18-75 years old (including upper and lower limits), both male and female;\n3. Rheumatoid arthritis (RA) diagnosed according to the 2010 American College of Rheumatology (ACR)\u002FEuropean League against Rheumatism (EULAR) classification, or Systemic sclerosis (SSc) according to the 2013 ACR\u002FEULAR classification;\n4. Interstitial lung disease (ILD) was confirmed by HRCT within 12 months before screening.\n5. FVC≥ 40% of the expected value during the screening period;\n6. DLCO (using hemoglobin correction) ≥ 40% of the expected value during the screening period;\n7. Patients may receive 1 immunosuppressant and must maintain a stable dose for 3 months prior to the first dose and agree to maintain a stable dose for at least 6 months after the first dose;\n8. Subjects of childbearing age who do not plan to become pregnant or donate sperm\u002Feggs and agree to use reliable contraception during the period of participation in this trial and within 6 months after the last dosing.\n\nExclusion Criteria:\n\n1. Allergic to experimental drugs or biological agents; People who have previously known other severe allergic reactions;\n2. Airway obstruction (FEV1\u002FFVC\\\u003C0.7 before bronchodilator use) or other lung abnormalities deemed clinically significant by the investigator or a history of asthma;\n3. Those who have received any of the following drugs or treatments :\n\n   1. Receiving prednisone \\>15mg\u002F day or equivalent dose of glucocorticoid within 2 weeks prior to randomization;\n   2. Receive azathioprine, colchicine, D-penicillamine, sulfasalazine within 8 weeks before randomization;\n   3. received rituximab, tolizumab, nidanib, pirfenidone and other treatments within 6 months before randomization; Abacil, TNF inhibitors and other biologic agents were received within 3 months before randomization; Tofaciib, tacrolimus, cyclosporin A, and potassium para-aminobenzoate were used 30 days or 5 half-lives prior to screening, whichever was older.\n4. Combined with other rheumatic diseases, such as idiopathic inflammatory myopathy, systemic lupus erythematosus, Sjogren's syndrome, mixed connective tissue disease, systemic vasculitis;\n5. Significant pulmonary hypertension, meeting one of the following conditions:\n\n   1. Previous clinical or echocardiographic evidence of significant right heart failure;\n   2. Right cardiac catheterization showed cardiac index ≤ 2 l\u002Fmin\u002Fm2;\n   3. Pulmonary hypertension requiring extraenteral treatment with eprostol\u002Ftraprostacycline;\n6. There are active bleeding diseases of internal organs, or have a serious bleeding tendency (such as hemophilia, etc.), or are undergoing anticoagulant treatment;\n7. There are infections requiring systemic drug control within 7 days prior to screening; Diagnosed with active tuberculosis infection;\n8. Have received live or attenuated vaccine within 3 months prior to screening, or plan to receive live or attenuated vaccine during the study period; Vaccination against COVID-19 within 2 weeks prior to screening;\n9. Previous stem cell therapy or any type of bone marrow transplant; Previous solid organ transplants; Long-term systemic use of glucocorticoids for other diseases;\n10. There is a history of serious immunodeficiency, or other acquired or congenital immunodeficiency diseases;\n11. History of malignant tumor within 5 years before screening;\n12. Recipients of kidney dialysis;\n13. Presence of the following clinically significant heart diseases:\n\n    1. A history of chronic congestive heart failure, NYHA level IV; History of cardiac ejection fraction (EF) \\\u003C 30% by echocardiography;\n    2. Myocardial infarction, acute coronary syndrome, viral myocarditis, and pulmonary embolism occurred within 3 months; Coronary revascularization was performed within 6 months.\n    3. There are severe arrhythmias that require Class Ia or III antiarrhythmic drugs; Arrhythmias with diseased sinus syndrome, grade II type II or grade III atrioventricular block, and no pacemaker implanted;\n    4. During the screening period, electrocardiogram indicated QTcF interval ≥ 480 ms (according to Fridericia correction formula, where QTcF=QT\u002FRR\\^0.33), or a history of prolonged QTc interval;\n14. There are the following abnormalities in the laboratory test values during the screening period:\n\n    1. White blood cell count \\\u003C3×109\u002FL, neutrophil count \\\u003C1.5×109\u002FL;\n    2. PLT\\\u003C75×109\u002FL;\n    3. Total bilirubin \\>1.5×ULN, alanine aminotransferase (ALT) \\>3×ULN, aspartate aminotransferase (AST) \\>3×ULN;\n    4. Estimated glomerular filtration rate (eGFR) \\\u003C 60 ml\u002Fmin\u002F1.73m2;\n15. History or current positive results of serum virology tests:\n\n    1. hepatitis B surface antigen positive, or hepatitis B core antibody positive and HBV-DNA higher than the detection limit;\n    2. Hepatitis C virus (HCV) antibody positive;\n    3. Positive for human immunodeficiency virus (HIV) antibodies;\n    4. Those who are positive for treponema pallidum antibodies and need treatment for syphilis infection.\n16. Received treatment with any investigational drug or medical device in a clinical trial within 3 months prior to screening;\n17. Pregnancy test positive during screening period; Lactating women;\n18. The investigator assessed those who had other factors that made them unsuitable for participation in the trial","ALL","18 Years","75 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study was conducted in a randomized, double-blind, placebo-controlled design to evaluate the efficacy and safety of Genakumab injection in the treatment of CTD-ILD including Rheumatoid Arthritis associated Interstitial Lung Disease (RA-ILD) and Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD)",[26,27,28],"Systemic Sclerosis Associated Interstitial Lung Disease","Rheumatoid Arthritis Associated Interstitial Lung Disease (RA-ILD)","Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)",[30,31,32],"connective tissue disease-associated interstitial lung disease","Rheumatoid Arthritis associated Interstitial Lung Disease (RA-ILD)","Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD)","RECRUITING","2025-01-16",{"date":36,"type":37},"2025-01-17","ACTUAL",{"date":39,"type":37},"2023-12-30",{"date":41,"type":20},"2026-10-31",{"name":43,"class":44},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",4,"Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild)"]