[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"systemic-sclerosis-associated-interstitial-lung-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:systemic-sclerosis-associated-interstitial-lung-disease":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100506771","phase-2-a-study-of-the-efficacy-and-safety-of-belimumab-in-adults-with-systemic-sclerosis-associated-interstitial-lung-disease-100506771",false,"NCT05878717","A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease","A Phase 2\u002F3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy And Safety of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSC-ILD)","BLISSc-ILD","Inclusion Criteria:\n\n1. Participant is 18 years of age inclusive, or older at the time of signing the informed consent.\n2. Documented diagnosis of SSc as defined by the American College of Rheumatology \u002F European League Against Rheumatism 2013 SSc classification criteria.\n3. Diffuse cutaneous disease, defined as presence of thickened skin with mRSS \\>0 over at least one skin area proximal to elbows and\u002For knees in addition to distal areas involvement on Day 1.\n4. Total mRSS ≥15 on Day 1.\n5. Evidence of interstitial lung disease on centrally read screening HRCT.\n6. Anticentromere antibody negative on central test at screening.\n7. Evidence for active or progressive disease\n8. Participant has an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow SC injection at the abdomen or the front, middle region of the thigh.\n9. Participant is capable and willing to self-administer the study medication or has a caregiver who is capable and willing to administer the study medication throughout the study.\n10. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n\n    Is a Woman of Non-Childbearing Potential (WONCBP) OR Is a Woman of Childbearing Potential (WOCBP) and using a contraceptive method that is highly effective.\n11. Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n1. Systemic sclerosis-like illness, including but not limited to localized scleroderma (morphoea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro mucinous conditions (scleroedema, scleromyxoedema), scleroderma-like conditions that are associated with environmental chemical and drug exposure (e.g., toxic rapeseed oil, vinyl chloride, bleomycin, gadolinium-based contrast agents \\[nephrogenic systemic fibrosis\\], or due to metabolic disease).\n2. Primary diagnosis of a rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, systemic vasculitis, Sjogren's syndrome, antisynthetase syndrome, or mixed connective tissue disease, as determined by the investigator.\n3. FVC ≤45% of predicted, or a DLco (corrected for hemoglobin) ≤40% of predicted or requiring supplemental oxygen at screening.\n4. Pulmonary arterial hypertension, as determined by the investigator at, or prior to first day of dosing (Day 1).\n5. SSc renal crisis within 6 months prior to the first day of dosing (Day 1).\n6. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.\n7. Obstructive pulmonary disease (pre-bronchodilator FEV1\u002FFVC \\\u003C0.7).\n8. Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD).\n9. Previous or planned major organ transplant (e.g., heart, lung, kidney, liver) or bone marrow transplant (e.g., autologous stem cell transplant).\n10. Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 3 months or 5 half-lives (whichever is longer) prior to dosing.\n11. Treatment with rituximab within 6 months prior to Day 1.\n12. Treatment with non-biologic systemic immunosuppressive medication, other than mycophenolate, methotrexate or azathioprine (including, but not limited to cyclosporine A, tacrolimus, leflunomide, oral or parenteral gold, Janus kinase (JAK) inhibitors) within 3 months prior to Day 1.\n13. Treatment with cyclophosphamide (oral or intravenous) within 6 months prior to Day 1.\n14. Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone or tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) within 4 weeks prior to Day 1.\n15. Cytotoxic drugs such as, chlorambucil, nitrogen mustard, or other alkylating agents within 6 months of Day 1.\n16. Treatment with IM or IV corticosteroids within 1 month prior to Day 1.","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).",[28,29],"Systemic Sclerosis Associated Interstitial Lung Disease","Scleroderma, Systemic",[31,32,33,34,35,36,37,38],"Monoclonal antibody","Autoimmune connective tissue disease","Skin","lung","systemic sclerosis","scleroderma","interstitial lung disease","belimumab","RECRUITING","2026-01-09",{"date":42,"type":43},"2026-01-12","ACTUAL",{"date":45,"type":43},"2023-09-13",{"date":47,"type":21},"2029-07-12",{"name":49,"class":50},"GlaxoSmithKline","INDUSTRY",131,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"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","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","75 Years",{"count":60,"type":21},30,[24],"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)",[28,64,65],"Rheumatoid Arthritis Associated Interstitial Lung Disease (RA-ILD)","Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)",[67,68,69],"connective tissue disease-associated interstitial lung disease","Rheumatoid Arthritis associated Interstitial Lung Disease (RA-ILD)","Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD)","2025-01-16",{"date":72,"type":43},"2025-01-17",{"date":74,"type":43},"2023-12-30",{"date":76,"type":21},"2026-10-31",{"name":78,"class":50},"Changchun GeneScience Pharmaceutical Co., Ltd.",4,"Systemic Sclerosis-associated Interstitial Lung Disease"]