[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ctd-ild\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ctd-ild":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":36,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100565589","p4o2-ild-extension-100565589",false,"NCT06644144","P4O2 ILD Extension","Early Identification of Progressive Pulmonary Fibrosis, Precision Medicine for More Oxygen - ILD Extension.","P4O2-ILD","Inclusion Criteria:\n\n* Diagnosis of (1) idiopathic pulmonary fibrosis (IPF), familial pulmonary fibrosis (FPF), (2) other fibrotic ILDs (fILD), including fibrotic hypersensitivity pneumonitis (fHP), idiopathic non-specific interstitial pneumonia (iNSIP), connective tissue disease (CTD)-ILD, and unclassifiable ILD (uILD); or (3) interstitial lung abnormalities (ILA).\n* Meeting all the following criteria during the screening period:\n\n  1. FVC ≥45% predicted.\n  2. FEV1\u002FFVC ≥0.7.\n  3. DLco corrected for Hb ≥40% predicted.\n* Able to provide written informed consent as approved by the independent ethics committee.\n* Able to undergo a CT scan and perform PFT.\n* Age \\> 18 years and \\< 80 years.\n* Understanding of the Dutch or English language.\n\nExclusion Criteria:\n\n* Combined pulmonary fibrosis and emphysema (CPFE) diagnosis\n* Chronic obstructive lung disease (COPD) with an FEV1\u002FFVC \\<70%.\n* Uncontrolled severe asthma.\n* Active malignancy, except for squamous cell carcinoma of the skin, low-risk breast cancer, and low-risk prostate cancer.\n* Pregnancy or lactating.","ALL","18 Years","80 Years",{"count":21,"type":22},450,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to identify early biomarkers that can predict the development of progressive pulmonary fibrosis (PPF) in participants with interstitial lung diseases (ILDs). The participant population includes adults diagnosed with idiopathic pulmonary fibrosis (IPF), familial pulmonary fibrosis (FPF), other fibrotic ILDs, and interstitial lung abnormalities (ILA).\n\nThe main questions it aims to answer are:\n\n* What biomarkers and risk factors are linked to fibrosis progression or can predict rapid worsening and sudden flare-ups in IPF and FPF patients?\n* What biomarkers and risk factors can predict the development of a PPF phenotype in different types of ILD?\n* What biomarkers and risk factors can help identify ILA patients who may develop significant ILD?\n* What biomarkers and risk factors can predict how well ILD patients will respond to treatment?\n\nResearchers will compare the outcomes between participants diagnosed with IPF\u002FFPF, other fibrotic ILDs, and ILA to see if early detection biomarkers differ among these groups.\n\nParticipants will:\n\n* Undergo blood sampling.\n* Perform lung function tests.\n* Have CT scans.\n* Perform breath analysis\n* Participate in exposome and microbiome analyses.\n* Complete questionnaires.\n* A subgroup of participants will be offered bronchoscopy.",[26,27,28,29,30,31,32,33,34,35],"Interstitial Lung Disease","Pulmonary Fibrosis","Interstitial Lung Fibrosis","IPF","Pulmonary Fibrosis, Idiopathic","Pulmonary Fibrosis Idiopathic Familial","Chronic Hypersensitivity Pneumonitis","Unclassifiable ILD","Idiopathic NSIP","CTD-ILD",[26,37,38],"Interstitial Lung Abnormalities","Progressive Pulmonary Fibrosis","RECRUITING","2026-05-05",{"date":42,"type":43},"2026-05-11","ACTUAL",{"date":45,"type":43},"2024-11-01",{"date":47,"type":22},"2031-10-01",{"name":49,"class":50},"Amsterdam UMC, location VUmc","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":51},"100631004","phase-3-phase-iii-clinical-trial-of-telitacicept-injection-in-the-treatment-of-patients-with-connective-tissue-disease-related-interstitial-lung-disease-100631004","NCT07495033","Phase III Clinical Trial of Telitacicept Injection in the Treatment of Patients With Connective Tissue Disease-related Interstitial Lung Disease","Inclusion Criteria:\n\n1. Voluntary informed consent provided;\n2. Male or female aged ≥ 18 years old;\n3. Documented diagnosis of rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM), Sjogren's syndrome (SjD) , Systemic sclerosis（SSc）,or mixed connective tissue disease (MCTD) in accordance with internationally recognized classification criteria;\n4. Diagnosis of ILD on High Resolution Computed Tomography (HRCT) with disease extent of greater than or equal to (≥) 10% of the whole lung (WL-ILD);\n5. During screening, FVC%Pred ≥ 45%;\n6. During screening, DLCO%Pred(corrected for hemoglobin) ≥ 30%;\n7. Stable standard treatment was received before randomization to control ILD and\u002For connective tissue disease;\n\nExclusion Criteria:\n\n1. Diagnosis of Interstitial lung disease other than CTD-ILD;\n2. ILD progresses rapidly within 12 weeks before screening or during screening;\n3. During screening, HRCT showed severe emphysema (the degree of emphysema exceeded that of ILD);\n4. Obstructive pulmonary disease (pre-bronchodilator Forced Expiratory Volume (FEV1) \u002FFVC \\\u003C0.7);\n5. Pulmonary arterial hypertension requiring therapy, as determined by the investigator;\n6. Having diffuse alveolar hemorrhage (DAH) or other pulmonary conditions that may have confounding effects, as well as related signs or symptoms;\n7. Unable to complete the pulmonary function test, or requiring supplementary oxygen supply;\n8. Clinically significant laboratory abnormalities;\n9. QTc interval prolongation on ECG;\n10. Allergy to human or mouse-derived biological products, or history of other drug allergies, and the investigator deems that the patient is not eligible to participate.\n11. Previous treatments received:\n\n    * Previous or planned organ transplantation or bone marrow transplantation;\n    * Plasma exchange or extracorporeal light separation exchange was performed within 6 months before randomization, or a plasma filtration device was used;\n    * Any targeted BLyS or APRIL drug treatment was received within 12 weeks before randomization;\n    * Biologic therapy was received within 12 weeks or within 5 half-lives of the corresponding drug (whichever is longer) before randomization;\n    * B-cell depletion drugs were used within 6 months before randomization;\n    * Non-biological systemic immunosuppressive drugs other than standard treatment were used within 4 weeks before randomization;\n    * Anti-fibrotic drugs were used within 4 weeks before randomization;\n    * Cyclophosphamide treatment was received within 6 months before randomization;\n    * Cytotoxic drugs were used within 6 months before randomization;\n    * Intravenous or intramuscular glucocorticoids were used within 4 weeks before randomization;\n12. Major surgery within 12 weeks prior to screening or planned during the duration of the study；\n13. Received or plan to receive any live vaccine within 28 days prior to randomization;\n14. Participation in any clinical trial 28 days prior to randomization or within 5 times the half-life of an investigational drug (whichever is longer);\n15. has active hepatitis or a history of severe liver disease；\n16. Acute or chronic infection requiring treatment;\n17. suffered from symptomatic herpes zoster within 12 weeks prior to screening;\n18. Active tuberculosis；\n19. HIV infection;\n20. History of malignant tumors；\n21. Significant cardiovascular disease, liver, kidney, respiratory, endocrine or hematologic disease, or other medical conditions that, in the opinion of the investigator, would preclude the subject's participation in the study or require hospitalization during the trial;\n22. History of drug or alcohol abuse or dependence；\n23. Pregnant or lactating women, and those intending to become pregnant during the trial;\n24. Patients considered unsuitable by the investigator to participate in the trial ;",{"count":59,"type":22},260,"INTERVENTIONAL",[62],"PHASE3","Interstitial lung disease (ILD) is a common pulmonary manifestation in chronic tissue diseases (CTD), significantly affecting patient's prognosis.\n\nThe main purpose of this study is to evaluate the efficacy of telitacicept compared with placebo in slowing down the decline in lung volume in patients with interstitial lung disease associated with connective tissue disease (CTD-ILD) on the basis of standard treatment.",[35],"NOT_YET_RECRUITING","2026-04-06",{"date":68,"type":43},"2026-04-09",{"date":70,"type":22},"2026-04-20",{"date":72,"type":22},"2030-05-31",{"name":74,"class":75},"RemeGen Co., Ltd.","INDUSTRY",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":83,"targetDuration":4,"studyType":60,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":51},"100579343","phase-1-clinical-trial-of-human-umbilical-cord-mesenchymal-stem-cells-ixcell-huc-msc-p-in-the-treatment-of-ctd-ild-100579343","NCT06823063","Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cells (IxCell hUC-MSC-P) in the Treatment of CTD-ILD","A Phase I Clinical Trial to Evaluate the Safety and Tolerability of a Single Dose of Human Umbilical Cord Mesenchymal Stem Cell Injection (IxCell hUC-MSC-P) in Patients With Connective Tissue Disease-associated Interstitial Lung Disease","Inclusion Criteria:\n\n1. Both sexes, aged 18-80 years;\n2. SSc diagnosed according to the 2013 American College of Rheumatology and European League Against Rheumatism (ACR\u002FEULA) criteria:\n3. Pulmonary fibrosis ≥10% was confirmed by high-resolution chest computed tomography (HRCT);\n4. The diffusion capacity for carbon monoxide (DLco) was 30%-89% of the expected value, and progression of interstitial lung disease was found. Progression was confirmed if one of the following criteria was met:\n\n   1. A decline of 10% or more in the percentage of predicted forced vital capacity (FVC%p) within 24 months (significant decline in ventilatory function) despite treatment;\n   2. A decline of ≥5% in FVC%p + a decline of ≥15% in DLco (a decline in ventilation function + a decline in diffusion capacity) within 24 months despite treatment;\n   3. Within 24 months, high resolution CT (HRCT) showed worsening of pulmonary fibrosis + ≥5% decline in FVC%p (deterioration of lung imaging + decline in ventilatory function), despite treatment.\n   4. Despite the treatment, 24 months reduced FVC % p + 5% or higher clinical symptoms (reduced ventilation function + symptoms);\n   5. Worsening of pulmonary fibrosis on HRCT + worsening of clinical symptoms (worsening of lung imaging + worsening of symptoms) within 24 months despite treatment;\n5. Forced Vital Capacity (FVC) was greater than 40% of expected vital capacity;\n6. The patient was able to complete the 6-Minute Walk Test (6MWT);\n7. Be able to understand and complete pulmonary function test procedures.\n8. Fully informed experiment purposes, methods, and possible uncomfortable, willing to medicine and follow-up inspection on time, according to the requirements of plan agreed to participate in trials, and sign the informed consent.\n\nExclusion Criteria:\n\n1. The patients were diagnosed with other lung diseases other than SSc-ILD, such as COPD, lung abscess, lung cancer and other types of connective tissue disease-related interstitial lung disease.\n2. Have obvious acute lung infection requiring anti-infection treatment (treatment of 4 weeks prior to the start of the respiratory tract infection and systemic infection);\n3. History of severe pulmonary hypertension, including right heart failure, cardiac intubation, and parenteral administration of prostaglandin analogues;\n4. History of myocardial infarction or angina pectoris within 6 months before enrollment;\n5. Patients with 3 or more fingertip ulcers when signing the informed consent form or unable to accurately observe fingertip ulcers due to other reasons of the hand;\n6. Allergic to any component of the medication;\n7. Life expectancy of less than 1 year due to diseases other than SSc;\n8. Planned surgical procedures during the trial;\n9. Has a history of scleroderma kidney crisis;\n10. Patients who had used glucocorticoids within 2 weeks before enrollment but could not maintain the dosage ≤10mg\u002F d equivalent prednisone;\n11. Patients who had used methotrexate within 2 months before enrollment, or failed to maintain a stable dosage while using other immunosuppressants;\n12. Into groups of 2 months before used anti fibrosis drug (such as pyrazole ketone, dani, cloth, etc.);\n13. Patients treated with rituximab, tocilizumab and mesenchymal stem cells within 2 months before enrollment;\n14. Patients with other systemic diseases and organ dysfunction (ALT\\>1.5 times upper limit of normal; Cr\\>1.5 times upper limit of normal; LVEF≤40%; Other progressive or uncontrolled diseases);\n15. Active hepatitis, tuberculosis, HIV infection;\n16. Patients with malignant tumors or a history of cancer;\n17. Pregnant or lactating women or those who have recently planned to have children and cannot take effective contraceptive measures;\n18. People with a history of alcohol or drug abuse;\n19. Enrolled in another drug trial within 3 months before enrollment;\n20. Unable to complete all assessors;\n21. And anyone who was deemed by the investigator to be ineligible for inclusion.",{"count":84,"type":22},18,[86],"PHASE1","To evaluate the safety and tolerability of IxCell hUC-MSC-P in the treatment of patients with connective tissue disease-related interstitial lung disease.\n\nTo evaluate the efficacy, pharmacokinetics and immunogenicity of IxCell hUC-MSC-P in the treatment of connective tissue disease-associated interstitial lung disease (CTD-ILD).",[35],"2025-02-12",{"date":91,"type":43},"2025-02-14",{"date":93,"type":22},"2025-04-01",{"date":95,"type":22},"2026-12-31",{"name":97,"class":50},"Shanghai IxCell Biotechnology Co., LTD"]