[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idiopathic-pulmonary-fibrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idiopathic-pulmonary-fibrosis":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,57,0,25,[9,47,71,95,115,136,166,188,208,235,265,294,319,343,366,389,412,436,457,480,504,529,549,576,596],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100614812","study-to-evaluate-the-efficacy-safety-and-tolerability-of-pipe-791-in-subjects-with-idiopathic-pulmonary-fibrosis-100614812",false,"NCT07284459","Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis","A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis","Key Inclusion Criteria:\n\n* Male or female ≥ 40 years of age at the time of Randomization.\n* A diagnosis of IPF within 7 years prior to Screening, based on the 2022 ATS\u002FERS\u002FJRS\u002FALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT consistent with usual interstitial pneumonia (UIP) or probable UIP.\n* Percent predicted (pp) FVC ≥ 40% on Screening spirometry.\n* Participants may enter the study whether or not they are receiving background nintedanib or pirfenidone therapy approved for the treatment of IPF, but not both concurrently.\n\nKey Exclusion Criteria:\n\n* Those with a history of interstitial lung disease (ILD) other than IPF are not eligible.\n* Those with pulmonary arterial hypertension (PAH) requiring multi-drug therapy are not eligible.\n* Those who have experienced an IPF exacerbation within 6 weeks of Screening, or during Screening, are not eligible.\n* Those with an estimated glomerular filtration rate (eGFR) ≤ 30 ml\u002Fmin\u002F1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] formula) (Inker 2021) or who have Child-Pugh Class B or C hepatic impairment are not eligible.\n* Female participants must not be of childbearing potential.\n\nAdditional inclusion and exclusion criteria apply.","ALL","40 Years",{"count":20,"type":21},324,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in participants with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.",[27],"Idiopathic Pulmonary Fibrosis",[27,29,30,31,32,33],"PIPE 791","Pulmonary Fibrosis","IPF","ILD","Interstitial lung disease","RECRUITING","2026-08-19",{"date":37,"type":38},"2026-08-20","ACTUAL",{"date":40,"type":38},"2026-01-08",{"date":42,"type":21},"2028-06",{"name":44,"class":45},"Contineum Therapeutics","INDUSTRY",68,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100534422","phase-3-a-follow-up-study-to-test-long-term-treatment-with-nerandomilast-in-people-with-pulmonary-fibrosis-who-took-part-in-a-previous-study-with-nerandomilast-100534422","NCT06238622","A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast","An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)","FIBRONEER™-ON","Inclusion Criteria:\n\n1. Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)\n2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control\n\nExclusion Criteria:\n\n1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion.\n2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:\n\n   * any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)\n   * any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)\n3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore \\>14 at Visit 1.\n4. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.\n5. Patient will undergo lung transplantation, with an assigned date of surgery.\n6. Patients with a Body Mass index (BMI) \\\u003C18.5 kg\u002Fm² that experienced an additional, unexplained and clinically significant (\\>10%) weight loss during the parent trial\n7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial\n8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.\n\nFurther exclusion criteria apply.","18 Years",{"count":57,"type":21},1700,[59],"PHASE3","This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550.\n\nThe goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.\n\nEvery participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study.\n\nParticipants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.",[27,62],"Progressive Pulmonary Fibrosis",{"date":37,"type":38},{"date":65,"type":38},"2024-05-06",{"date":67,"type":21},"2027-05-05",{"name":69,"class":45},"Boehringer Ingelheim",373,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100536619","early-phase-1-a-clinical-study-to-evaluate-safety-tolerability-and-pharmacokinetics-of-sv001-in-chinese-healthy-adult-volunteers-100536619","NCT06267183","A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.","A Phase I, Single-center, Randomized, Double-blind, Single-dose, Dose-ascending, Placebo-controlled Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.","Inclusion Criteria:\n\n1. Subjects must fully understand the purpose, characteristics, methods and possible adverse reactions of the trial, volunteer as a subject, and sign the Informed Consent Form;\n2. Subjects must have a Body Mass Index in the range of 19\\~26 kg\u002Fm2, with males weighted not less than 50 kg, and females weighted not less than 45 kg;\n3. Subjects must be in good health as judged by the investigator.\n4. Reliable contraception must be assured during and for some time after the trial.\n\nExclusion Criteria:\n\n1. Subjects with a history of drug or other substance anaphylaxis;\n2. Subjects with respiratory symptoms or abnormal respiratory tract;\n3. Subjects currently having an oral disease that the investigator judged may affect use of the trial drug and devices;\n4. Subjects with other diseases or factors with abnormal clinical manifestations;\n5. Subjects having a history of drug abuse in the past or having used narcotics in the period prior to screening, or having a positive result in urine narcotics test at baseline period;\n6. Subjects who smoked more than 5 cigarettes a day in the period before screening;\n7. Subjects who consumed more than 14 units of alcohol per week in the period prior to screening, or who is positive in breath alcohol test at baseline period;\n8. Subjects who have suffered a clinically significant severe disease or undergone major surgical operations within a certain period of time prior to receiving the investigational drug, or who are expected to require major operations during the clinical trial;\n9. Subjects who used other drugs within a certain period of time before receiving the investigational drug;\n10. Screening period: FEV1≤80% predicted value or FVC≤80% predicted value;\n11. Subjects who have antibody positive for Human Immunodeficiency Virus, Hepatitis B surface antigen, Hepatitis C or Treponema Pallidum.\n12. Subjects who have difficulty in venous blood collection or have a history of acupuncture syncope and blood phobia;\n13. Female subjects who are tested positive for pregnancy during the screening or baseline period or are in lactation period;\n14. Subjects who have participated in other drug clinical trials and used other drugs in clinical trials within a certain period of time before receiving the investigational drug;\n15. Subjects who have a history of blood donation or blood loss of more than 400 mL in the period prior to screening;\n16. Any other status in which the investigator deems inappropriate to participate in the present study.","45 Years",{"count":80,"type":21},53,[82],"EARLY_PHASE1","The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.",[27],"2026-08-13",{"date":87,"type":38},"2026-08-14",{"date":89,"type":38},"2024-01-12",{"date":91,"type":21},"2026-12-30",{"name":93,"class":45},"Shanghai Synvida Biotechnology Co.,Ltd.",1,{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":94},"100650221","emotional-and-social-experiences-of-antifibrotic-af-therapy-among-idiopathic-pulmonary-fibrosis-ipfprogressive-pulmonary-fibrosis-ppf-patients-a-real-world-study-100650221","NCT07743996","Emotional and Social Experiences of Antifibrotic (AF) Therapy Among Idiopathic Pulmonary Fibrosis (IPF)\u002FProgressive Pulmonary Fibrosis (PPF) Patients: A Real-World Study","A Real-World Study of the Perceived Emotional and Social Experiences Related to Antifibrotic Therapy in Patients With IPF and PPF: A Cross-Sectional Web-Based Survey","Inclusion Criteria:\n\n1. Patients with IPF aged 40 years or older who received nintedanib or pirfenidone within the previous 4 weeks, or patients with PPF aged 18 years or older who received nintedanib within the previous 4 weeks\n2. Patients capable of responding to a self-administered questionnaire\n\nExclusion Criteria:\n\n1. Patients treated with nerandomilast (including clinical trials)\n2. Patients with PPF treated with pirfenidone\n3. Patients currently hospitalized\n4. Patients with malignant tumors",{"count":103,"type":21},100,"OBSERVATIONAL","This is a cross-sectional study that will be conducted across Japan using an online patient-reported outcome questionnaire.\n\nThis study tries to find out the attitudes toward and experiences of the emotional and\u002For social impact of side effects associated with antifibrotic (AF) treatment among Japanese patients with Idiopathic Pulmonary Fibrosis (IPF)\u002FProgressive Pulmonary Fibrosis (PPF), and how are these attitudes associated with patients' individual characteristics.",[27,62],"2026-08-10",{"date":109,"type":38},"2026-08-12",{"date":111,"type":38},"2026-08-01",{"date":113,"type":21},"2026-09-30",{"name":69,"class":45},{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":94},"100390340","phase-1-molecular-imaging-probes-to-inform-heterogeneity-in-idiopathic-pulmonary-fibrosis-100390340","NCT04362644","Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis","Inclusion Criteria:\n\n1. Age between 40-85 years old.\n2. A diagnosis of IPF that fulfills American Thoracic Society (ATS) \u002F European Respiratory Society (ERS) 2018 consensus criteria within 5 years.\n3. Ability and willingness to give informed consent and adhere to study requirements.\n4. Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1\u002FFVC) \\>0.70.\n5. High or mixed affinity binder for TSPO ligands based on genotyping for single-nucleotide polymorphism (SNP)rs6971.\n\nExclusion Criteria:\n\n1. Acute exacerbation of IPF within \\\u003C30 days\n2. Diagnosis of Diabetes Mellitus (Type 1 or Type 2).\n3. Diagnoses of current infection by clinical or microbial assessments.\n4. Treatment for \\>14 days within the preceding month with \\>20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular immunosuppressant.\n5. Subjects with prior radiation therapy to the thorax.\n6. Women who are pregnant, or who are breastfeeding. IPF is a disease of older adults, and male predominant, so this will not be a frequent consideration.\n7. Severe cardiovascular disease, defined as any of the following within the preceding 12 weeks: acute myocardial infarction or unstable angina, a coronary revascularization procedure, or stroke.\n8. Subjects with known liver disease.\n9. Diagnosis of any active cancer with the exception of basal cell carcinoma of skin.\n10. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.\n11. Active cigarette smoking or vaping","85 Years",{"count":123,"type":21},10,[125],"PHASE1","The purpose of the study is to see if imaging with fluorine-18 Fluorodeoxyglucose (\\[18F\\] FDG) and fluorine-18 Displacement Per Atom (\\[18F\\]DPA-714) using positron emission tomography and computed tomography (PET\u002FCT) will show lung inflammation and fibrosis in patients diagnosed with idiopathic pulmonary fibrosis (IPF). This study may help physicians and researchers better understand how best to treat patients with IPF in the future.",[27],{"date":109,"type":38},{"date":130,"type":38},"2020-12-08",{"date":132,"type":21},"2027-06",{"name":134,"class":135},"University of Alabama at Birmingham","OTHER",{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":148,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100590468","wisper-evaluation-of-mtx-463-in-participants-with-idiopathic-pulmonary-fibrosis-ipf-100590468","NCT06967805","WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)","A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)","Inclusion Criteria:\n\n* Participants with IPF of any gender ≥ 40 years of age at time of signing the informed consent.\n* Able to understand the study and provide signed, written informed consent.\n* Able to read and understand the language of the informed consent and other study-related materials.\n* Meet the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Association (ATS\u002FERS\u002FJRS\u002FALAT) 2019 criteria for the diagnosis of IPF; Diagnosed with IPF within 7 years of screening.\n* If a participant is on treatment with pirfenidone, nintedanib, or nerandomilast, the dose of the medication must be stable for ≥ 90 days prior to Screening with plans to maintain the same dose throughout the study. Use of any of these 3 agents in combination with each other is not permitted.\n* If a participant was on treatment with pirfenidone, nintedanib, or nerandomilast, and the agent has been discontinued, this must have occurred ≥ 30 days prior to Screening. At Screening, there must also be no plan to start either of these medications for the duration of the study. Participants newly diagnosed with IPF who, in the judgment of the treating physician, are considered in need of treatment with nintedanib, pirfenidone, or nerandomilast should not defer standard of care treatment and should be excluded from the study.\n* FVC of ≥ 45 percent predicted (pp) at screening.\n* DLCO of ≥ 25pp at screening.\n* Willing and able to complete all protocol required study visits and procedures.\n* Female participants of childbearing potential must have a negative serum pregnancy test at Screening.\n* Participants with reproductive potential must agree to use and follow medically approved highly effective methods of contraception during treatment and until 5 half-lives or 125 days after the last dose of study drug, whichever is longer.\n* Male participants with female partners of childbearing potential must use condoms during the treatment and until 5 half-lives or 125 days after the last dose of study drug, whichever is longer.\n\nExclusion Criteria:\n\n* Acute exacerbation of IPF within 6 months of Screening or during the Screening Period.\n* Forced expiratory volume in 1 second (FEV1)\u002FFVC ratio of \\\u003C0.7 at Screening.\n* Requirement for continuous supplemental oxygen. Intermittent supplemental oxygen use (e.g., during exercise or sleep) is permitted.\n* Expected to receive a lung transplant within the study duration.\n* Current active bacterial infection or use of antibiotics for suspected lung infection in the 30 days prior to Screening.\n* Planned surgery within the study duration.\n* Clinically significant pulmonary hypertension.\n* Use of immunosuppressive therapy (excluding corticosteroids). If previously on such agents, they should have been discontinued for at least 5 half-lives or 90 days, whichever is longer, prior to Screening.\n* Use of systemic corticosteroids (prednisone or equivalent) at a dose \\> 10 mg once daily within 30 days of Screening.\n* Currently smoking or vaping.\n* Current known malignancy, or history of cancer, or lymphoproliferative disorder other than non-melanomatous skin cancers, within 2 years of Screening.\n* Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).\n* Currently pregnant, breast feeding, or planning to conceive for the length of the study.\n* History of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 2 years of Screening.\n* Any clinically significant disease or laboratory abnormality detected at Screening that might interfere with a participant's ability to complete the study, on-study evaluations, or participant safety.\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2× upper limit of normal (ULN) at Screening.\n* Presence of interstitial lung disease due to any cause other than IPF, clinically significant cardiovascular disease, or any other concurrent active medical condition determined by the Investigator to interfere with the participant's ability to complete the trial.\n* Known allergy to MTX-463 or any of its excipients, or a history of a prior allergic reaction to a monoclonal antibody therapeutic.\n* Any prior use of MTX-463 or other therapy targeting WISP1.\n* Any other concurrent experimental agent or an active part of any other clinical study, unless they have stopped taking the investigational product at least 5 half-lives or 30 days before Screening, whichever is longer.",{"count":144,"type":21},164,[24],"A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)",[27],[149,150,31,27,151,152,153,154,155,156],"MTX-463-I201","MTX-463","Adult","Fibrosis","Monoclonal Antibody","MAB","FVC","WISPer","2026-08-06",{"date":107,"type":38},{"date":160,"type":38},"2025-05-05",{"date":162,"type":21},"2027-08",{"name":164,"class":45},"Mediar Therapeutics",71,{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":179,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":184,"leadSponsor":186,"locationsCount":94},"100515204","phase-1-dose-escalation-study-of-artesunate-patients-with-ipf-100515204","NCT05988463","Dose-Escalation Study of Artesunate Patients With IPF","A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Participants With Idiopathic Pulmonary Fibrosis (SAFE-IPF)","SAFE-IPF","Inclusion Criteria\n\nEach participant must meet the following criteria to be enrolled in this study:\n\n1. Age 40 years or older.\n2. Diagnosis of IPF based upon ATS\u002FERS\u002FJRS\u002FALAT 2018 guidelines (56)\n3. FVC percent of predicted ≥ 30%; historical FVC for entry in the study is permitted if within 3 months of screening.\n4. Diffusing capacity of lung for carbon monoxide (DLco) (hemoglobin-adjusted) ≥ 25%; historical DLco for entry in the study is permitted if within 3 months of screening.\n5. Participants receiving nintedanib, pirfenidone, and\u002For nerandomilast for the treatment of idiopathic pulmonary fibrosis (IPF), including combination therapy (e.g., nintedanib plus nerandomilast or pirfenidone plus nerandomilast), are eligible for enrollment. All background IPF therapies must be stable for at least 6 weeks prior to the Screening visit and taken continuously with no or only rare interruptions.\n6. Female participants of childbearing potential (i.e., ovulating, premenopausal, and not surgically sterile) and all male participants with sexual partners of childbearing potential agree to use highly effective methods of birth control during their participation in the study and for 60 days after the last administration of study drug. Women of child-bearing potential are defined as any female who has experienced menarche and who is not permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.\n\n   Highly effective methods of birth control are defined as those with 99% or greater efficacy and includes:\n\n   Use of hormonal contraception that inhibits ovulation, administered orally, by injection, implant, transdermal patch, or vaginal ring Vasectomized male partner Sexual abstinence, only if it is the participant's consistent and preferred lifestyle Infertile partner, confirmed by medical evaluation\n7. Participants must agree to abstain from egg or sperm donation through 60 days after administration of the last dose of study drug.\n8. Able to read and sign a written informed consent form (ICF).\n\n7.3 Exclusion Criteria Participants who meet any of the following criteria will be excluded from the study.\n\n1. Receiving any nonapproved agent intended for treatment of fibrosis in IPF or participation in other treatment clinical trials.\n2. Clinical evidence of active infection within 30 days of screening, including but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening.\n3. Known acute IPF exacerbation, or suspicion by the Investigator of such, within 3 months of screening.\n4. The extent of emphysema is greater than the fibrotic changes on the most recent HRCT scan as determined by PI.\n5. Any medical condition, not limited to cardiac, hepatic, renal disease or malignancy, in recent months that will make the participants unsuitable for the study, as judged by the PI.\n6. Any of the following liver test results above the listed specified limits: total bilirubin \\>2× the upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>3× ULN; alkaline phosphatase (ALP) \\> 2.5× ULN, pending PI's discretion.\n7. Hemoglobin \\\u003C 10.0 g\u002FdL.\n8. Pregnant or lactating.\n9. Likely to undergo lung transplantation during the study (being on transplantation list is acceptable).\n10. Currently receiving and expected to remain on treatment during the study with drugs interacting with artesunate including amodiaquine, and efavirenz, nevirapine and ritonavir.",{"count":175,"type":21},15,[125],"Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive fibrotic lung disease resulting in increasing shortness of breath, cough, and low oxygen levels as a result of lung tissue scarring . This will be a single-center randomized, double-blinded, placebo-controlled study of 20 weeks including up to 4 weeks for screening, followed by 12 weeks of oral artesunate treatment across 3 dose levels (dose escalation every 4 weeks), and 4 weeks of a washout (follow-up) period in participants with Idiopathic Pulmonary Fibrosis (IPF). The primary objective of the study is to evaluate the safety and tolerability of artesunate at 3 dose levels, and to select the dose(s) to carry forward into additional clinical testing. The secondary objective includes exploring the blood biomarkers present in participants with IPF at baseline and to investigate how those biomarkers change following artesunate treatment. The exploratory objectives include assessing the changes in the K-BILD and Leicester cough questionnaire scores and change in pulmonary function after artesunate administration.",[27],[180],"shortness of breath, fibrosis, cough, hypoxemia",{"date":182,"type":38},"2026-08-11",{"date":111,"type":38},{"date":185,"type":21},"2028-11-01",{"name":187,"class":135},"Joseph C. Wu",{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},"100595751","phase-2-a-study-to-find-out-whether-bi-765423-has-an-effect-on-lung-function-in-people-with-idiopathic-pulmonary-fibrosis-ipf-with-or-without-standard-treatment-100595751","NCT07036523","A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) With or Without Standard Treatment","A Double-blind, Randomised, Placebo-controlled, Parallel Group, Phase IIa Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BI 765423 Administered Intravenously With or Without Standard of Care in Patients With Idiopathic Pulmonary Fibrosis","Inclusion Criteria :\n\n1. 40 years of age or older at the time of informed consent signature.\n2. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.\n3. Male or female patients. Male patients must not donate sperm while taking part in this study and for a specific period after the last dose of the IMP. Male patients with woman of childbearing potential (WOCBP) sexual partners must use contraception (male condom) to avoid exposure via seminal fluid during treatment and for a specific period after last drug intake. Women can only be included if they are of non-childbearing potential, defined as meeting at least one of the below conditions:\n\n   * Permanently surgically sterilised (hysterectomy, bilateral salpingectomy and\u002For bilateral oophorectomy)\n   * Postmenopausal, defined as no menses for 12 months without an alternative medical cause. In questionable cases wherein the menopausal status is uncertain and cannot be clearly determined, the following should be taken into consideration by the investigator:\n\n     * Women not using sex hormone medication such as hormone replacement therapy may be included if a blood sample confirms levels of follicle stimulating hormone (FSH) \\> 40 U\u002FL and estradiol \\\u003C 30 ng\u002FL\"\n4. Patients with a documented diagnosis of IPF prior to Visit 1, confirmed by the investigator as per the 2022 American Thoracic Society (ATS)\u002FEuropean Respiratory Society (ERS)\u002FJapanese Respiratory Society (JRS)\u002FLatin American Thoracic Association (ALAT) Guideline and, if available, surgical lung biopsy or transbronchial lung cryobiopsy histopathology report.\n5. Patients with a high-resolution computed tomography (HRCT) taken within 12 months of Visit 1 (or during the screening period, if not available) confirming \"UIP\" or \"probable UIP\" HRCT pattern consistent with the clinical diagnosis of IPF by central review (prior to Visit 2).\n\n   * Patients with an \"indeterminate\" HRCT finding are eligible if a clinical diagnosis of IPF can be confirmed based on an historical histopathology report of a surgical lung biopsy or cryobiopsy demonstrating a \"UIP\" or \"Probable UIP\" pattern or Multidisciplinary Discussion and Diagnosis as per ATS guidelines.\n   * Patients with an \"alternative diagnosis\" HRCT finding are eligible if a clinical diagnosis of IPF can be confirmed based on an historical histopathology report of a surgical lung biopsy or cryobiopsy demonstrating a \"UIP\" pattern Multidisciplinary Discussion and Diagnosis as per ATS guidelines.\n6. Patients with an extent of fibrosis ≥20% as per an HRCT of the chest performed within 12 months prior to Visit 1 or during the screening period (if not available) and confirmed by central review.\n7. Patients with a Forced vital capacity (FVC) ≥45% predicted at Visit 1. Predicted normal values will be calculated according to Global Lung Initiative (GLI).\n8. Patients with haemoglobin-corrected diffusing capacity of the lungs for carbon monoxide (DLCO) ≥20% predicted at Visit 1.\n\nFurther inclusion criteria apply.\n\nExclusion criteria:\n\n1. Acute exacerbation of IPF within at least 12 weeks prior to Visit 1 and\u002For during the screening period (investigator-determined).\n2. Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1 second (FEV1)\u002FFVC \\\u003C0.7) at Visit 1.\n3. Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and\u002For during the screening period.\n4. Significant PH defined by any of the following:\n\n   * Previous clinical or echocardiographic evidence of significant right heart failure according to investigator's judgement\n   * History of right heart catheterisation showing a cardiac index ≤2 L\u002Fmin\u002Fm\\^²\n   * PH requiring parenteral therapy with prostanoids\n5. On nintedanib or pirfenidone treatment for less than 12 weeks prior Visit 1, planning to start nintedanib or pirfenidone within the first 12 weeks of investigational medicinal product (IMP) treatment or on combined nintedanib plus pirfenidone treatment. Newly diagnosed patients considered in need of SoC treatment during the next 12 weeks by the treating physician, who would be withheld SoC treatment only for the sake of participation in the trial, should also be excluded.\n6. Cardiovascular comorbidities including\n\n   * Severe hypertension (uncontrolled under treatment≥160\u002F100 mmHg at multiple occasions) within 3 months of Visit 1\n   * Myocardial infarction, stroke, or transient ischemic attack within 6 months of Visit 1\n   * Unstable cardiac angina within 6 months of Visit 1\n7. Life expectancy for any concomitant disease other than IPF \\\u003C2.5 years (investigator assessment).\n\nFurther exclusion criteria apply.",{"count":165,"type":21},[24],"This study is open to adults who are at least 40 years old and have idiopathic pulmonary fibrosis (IPF). People can participate in the study if they have a forced vital capacity (FVC) greater than or equal to 45% of the predicted value and fibrosis of 20% or more confirmed by a high-resolution computed tomography (HRCT) scan. The purpose of this study is to find out if a medicine called BI 765423 can improve lung function in people with IPF. The study will compare BI 765423 with a placebo to see if there is a difference in lung capacity after 3-6 months of treatment and will also look at changes in certain markers related to lung health.\n\nParticipants are put into two groups randomly, which means by chance. One group receives the study medicine, and the other group receives a placebo. Placebo looks like BI 765423 but does not contain any study medicine. The study medicine is given as an infusion into a vein every four weeks.\n\nParticipants are in the study for up to 11 months. During the study, participants may continue their regular treatment for IPF. During the study they visit the study site several times for screening, treatment, and follow-up. Doctors regularly test lung function by measuring FVC and take blood samples to measure study endpoints. The results are compared between the two groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.",[27],"2026-07-26",{"date":201,"type":38},"2026-07-28",{"date":203,"type":38},"2025-11-13",{"date":205,"type":21},"2027-06-22",{"name":69,"class":45},46,{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":223,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":230,"leadSponsor":232,"locationsCount":94},"100541118","phase-2-h01-in-adults-with-interstitial-lung-disease-the-solis-study-100541118","NCT06325696","H01 in Adults With Interstitial Lung Disease (The SOLIS Study)","Phase IIa Investigation of H01 in Adults With Interstitial Lung Disease (The SOLIS Study)","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Ability of subject to understand, and the willingness to sign a written informed consent document and comply with requirements of the study\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or Female participants ages \\>18 years\n* MD diagnosis of Idiopathic Pulmonary Fibrosis or other progressive ILD as defined previously\n* DLCO\\>30% and FVC\\>45%\n* Subjects in reproductive age who are heterosexually active must use an acceptable method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, IUD, or Hormone-based contraceptive\n* Agreement to adhere to Lifestyle Considerations throughout study duration\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Active on lung transplantation list\n* On supplemental oxygen at rest\n* Evidence of an acute respiratory infection or exacerbation of pulmonary fibrosis\n* Known diagnosis of celiac disease or wheat or gluten allergies\n* Cirrhosis or active viral or non-viral hepatitis: Bilirubin, AST and ALT values higher than twice the upper range of normal, or a Child-Pugh score of 7 or more\n* Subjects with history of active Inflammatory Bowel Disease, dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills\n* Subjects with significant renal impairment defined as eGFR lower than 40 ml\u002Fmin.\n* Subjects with a baseline corrected Fridericia's QT interval (QTcF) \\>450ms or baseline ECG abnormalities which, in the opinion of the study physician, are clinically significant and would place the participant at increased risk for adverse effects.\n* Subjects with ongoing alcohol or illegal drug use disorder\n* Subjects who are pregnant, lactating or attempting to conceive\n\n  * Participants able to become pregnant (have not completed menopause, had a hysterectomy and\u002For both tubes and\u002For both ovaries removed) must use effective birth control methods to try and not become pregnant while participant in this study. Methods include (a) partner vasectomy, (b) bilateral tubal ligation, (c) intrauterine devices (IUDs), (d) hormonal implants (such as Implanon), or (e) other hormonal methods (birth control pills, injections, patches, vaginal rings).\n  * Male participants able to father children with a partner able to become pregnant must agree to use effective birth control (listed above) to participate in this study.\n* Known allergy to hymecromone or any component thereof\n* Chronic therapy with medications that are known potent human UDP-glucuronosyltransferase inhibitors: canagliflozin, temazepam, tacrolimus.\n* Physician concern that participant may not adhere to the study protocol\n* Current participation in another clinical treatment trial for ILD. May participate after 12 weeks from conclusion of another treatment trial.\n* Changing dose of other ILD medications over the 3 months prior to baseline\n* Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that place the participant at increased risk for adverse effects, as determined by the study physician.\n\nParticipants who completed the original 12-week treatment portion of the SOLIS study prior to the implementation of the optional 12-week extension phase may have the option to re-enroll under the amended protocol, after an appropriate washout period of up to 6 months. Participants will be re-screened as per criteria above to ensure that eligibility criteria continue to be met. Once eligibility is confirmed, participants can complete the 12-week treatment and optional 12-week extension for a maximum treatment period of 24 weeks. These re-enrolled participants will be enrolled as new participants and receive a different screening number to differentiate them from the original enrollment.","100 Years",{"count":217,"type":21},37,[24],"Background:\n\nInterstitial lung disease affects the tissues that aid the transfer of oxygen and carbon dioxide between the air and the bloodstream. The disease can cause fibrosis, a thickening and scarring of lung tissue. Fibrosis often continues getting worse, and most people with this disease die in 3 to 5 years.\n\nObjective:\n\nTo test a study drug (hymecromone) in people with interstitial lung disease or lung fibrosis.\n\nEligibility:\n\nPeople aged 18 years and older with interstitial lung disease or lung fibrosis.\n\nDesign:\n\nParticipants will have at least 7 clinic visits over 5 months.\n\nParticipants will have screening and baseline visits. They will have blood tests and tests of their heart function. They will give a sputum sample. Other tests will include:\n\nSpirometry: Participants will breathe in and out through a mouthpiece to measure how much air they can hold in their lungs and how hard they can breathe.\n\nDiffusion capacity of lungs for carbon monoxide: Participants will breathe in a gas that contains a small amount of carbon monoxide. Then they will breathe through a mouthpiece. This test measures how well oxygen moves from the air into the blood.\n\nResting energy expenditure. Participants will lie still for 30 minutes with a clear dome over their head. This test measures the calories their body burns at rest.\n\n6-minute walk test. Participants will walk at their normal pace for 6 minutes. Their vital signs and blood oxygen levels will be checked.\n\nHymecromone is a tablet taken by mouth. Participants will take 2 tablets every morning and 2 tablets every night for 12 weeks. Participants who decide to continue longer may enter an optional 12 week extension phase, for a maximum treatment time of 24 weeks. Tests will be repeated at study visits.",[221,27,222],"Interstitial Lung Disease","Lung Diseases, Interstitial",[30,224,225,226],"Lung disease","Hyaluronan","Drug","2026-07-25",{"date":201,"type":38},{"date":160,"type":38},{"date":231,"type":21},"2027-12-31",{"name":233,"class":234},"National Institute of Environmental Health Sciences (NIEHS)","NIH",{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":246,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":94},"100645054","phase-2-phase-2-clinical-trial-of-mnkd-201-nintedanib-dry-powder-inhalation-in-patients-with-idiopathic-pulmonary-fibrosis-100645054","NCT07679893","Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis","A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial of the Efficacy and Safety of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis Followed by an Open-Label Extension","INFLO-2","Inclusion Criteria:\n\n* 40-80 years old when signing consent and entering screening.\n* Diagnosed with IPF based on current ATS\u002FERS\u002FJRS\u002FALAT guidelines.\n* Either new to treatment or on a stable dose of pirfenidone and\u002For nerandomilast for at least 3 months before screening.\n* Weighs more than 40 kg (88 lb) at screening.\n* Women who can become pregnant:\n* Must have a negative pregnancy test at screening.\n* Must use an approved birth control method from screening until at least 1 month after the last study dose.\n* Men who can father a child and are sexually active with women who can become pregnant:\n* Must use an approved birth control method during treatment and for at least 3 months after the last study dose.\n* Must not donate sperm during treatment and for at least 3 months after the last study dose.\n* Willing to follow all study rules and restrictions.\n* Willing and able to attend study visits and complete study procedures.\n* Able to perform spirometry (lung function testing) as required by the study.\n\nExclusion Criteria:\n\n* Has a lung disease caused by something other than IPF.\n* Has a connective tissue or autoimmune disease (such as lupus, scleroderma, or rheumatoid arthritis).\n* Has another condition that significantly affects breathing.\n* Has serious heart or blood vessel disease.\n* Has a recent or current infection.\n* Was recently hospitalized for COVID-19, an IPF flare-up, or a lung infection.\n* Has a history of asthma (except childhood asthma that has resolved).\n* Has another medical condition or abnormal test result that may affect study participation or safety.\n* Cannot perform high-quality spirometry testing.\n* Has obstructive lung disease.\n* Has abnormal liver function tests.\n* Has moderate to severe liver disease.\n* Has severe kidney disease.\n* Has recently used high-dose steroids or other immune-suppressing medications.\n* Has active cancer or recent cancer treatment.\n* Is on, or expected to be added to, a transplant list.\n* Had major surgery recently or has planned procedures that could interfere with the study.\n* Has had a severe reaction to nintedanib or cannot take nintedanib safely.\n* Has recently used certain medications that may interact with the study drug.\n* Is currently using, or plans to use, prohibited medications during the study.\n* Has recently participated in another clinical trial.\n* Has current alcohol or drug abuse issues.\n* Donated a significant amount of blood recently.\n* Received a live vaccine recently.\n* Currently smokes, recently smoked, or quit smoking less than 1 year ago.\n* Requires more than 6 L\u002Fmin of oxygen while at rest.","80 Years",{"count":245,"type":21},210,[24],"This trial is a randomized, double-blind, placebo-controlled study evaluating the safety and preliminary efficacy of inhaled Nintedanib Dry Powder Inhalation (DPI) in adults with idiopathic pulmonary fibrosis (IPF). Participants are randomized to receive either 2 mg QID, 4 mg BID, or matching placebo for 12 weeks, followed by a 24-week open-label extension in which all participants receive active treatment. The primary focus is on safety-particularly bronchospasm events, lung function changes (FEV1, FEV1\u002FFVC), and adverse event rates and assessing the effectiveness of nintedanib DPI in treating IPF.",[27,249],"Idiopathic Pulmonary Fibrosis (IPF)",[251,252,253,254,255],"inhalable treatments","lung scarring","Pulmonary fibrosis","fibrosis","pulmonary","2026-07-23",{"date":258,"type":38},"2026-07-24",{"date":260,"type":21},"2026-06-30",{"date":262,"type":21},"2028-12",{"name":264,"class":45},"Mannkind Corporation",{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":274,"conditions":275,"keywords":278,"overallStatus":284,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":4},"100649020","predictors-of-pulmonary-embolism-in-interstitial-lung-disease-with-worsening-symptoms-100649020","NCT07728448","Predictors of Pulmonary Embolism in Interstitial Lung Disease With Worsening Symptoms","Predictors of Pulmonary Embolism in Patients With Interstitial Lung Diseases Presenting With Worsening Respiratory Symptoms","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed diagnosis of ILD based on multidisciplinary discussion and HRCT findings, with or without histopathological confirmation\n* Acute unexplained worsening of dyspnea, hypoxemia, chest pain, syncope, or clinical suspicion of PE\n* Undergoing CTPA as part of routine clinical management\n* Provision of informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnancy\n* Previously diagnosed acute pulmonary embolism receiving anticoagulant therapy\n* Active malignancy\n* Known inherited or acquired thrombophilia\n* Acute myocardial infarction or ischemic stroke within the previous month\n* Major surgery or trauma within four weeks\n* Severe renal impairment contraindicating contrast-enhanced CTPA",{"count":273,"type":21},70,"People with interstitial lung disease (ILD) can sometimes experience a sudden and severe worsening of their breathing. While this can be caused by a flare-up of the lung disease itself, it can also be caused by a blood clot in the lungs, known as a pulmonary embolism (PE). It is often difficult for doctors to tell the difference between these two emergencies because their symptoms, such as shortness of breath and low oxygen levels, are very similar. Traditional scoring systems used to predict blood clots are often less accurate for patients who already have chronic lung diseases like ILD.\n\nThe main goal of this observational study is to find better, more reliable ways to predict which ILD patients with worsening breathing symptoms actually have a pulmonary embolism.\n\nResearchers will observe 70 adult patients with ILD who come to the hospital with a sudden worsening of their symptoms (such as shortness of breath, chest pain, or low oxygen) and who require a specific type of CT scan (Computed Tomography Pulmonary Angiography, or CTPA) as part of their standard medical care to check for blood clots.\n\nThe study will compare the patients whose CT scan confirms a blood clot to those whose scan does not show a clot. By comparing these two groups, the research team will evaluate various clinical signs, routine blood tests, novel inflammatory markers, and heart\u002Flung imaging details.\n\nIdentifying strong predictors of pulmonary embolism in this specific group of patients could help doctors diagnose lung blood clots faster and more accurately, leading to better clinical decision-making and improved patient outcomes",[276,221,27,277],"Pulmonary Embolism","Connective Tissue Disease-associated Interstitial Lung Disease",[279,280,281,282,283],"Predictors","Inflammatory Biomarkers","Worsening Respiratory Symptoms","Computed Tomography Pulmonary Angiography (CTPA)","Acute Exacerbation","NOT_YET_RECRUITING","2026-07-22",{"date":287,"type":38},"2026-07-27",{"date":289,"type":21},"2026-08",{"date":291,"type":21},"2027-09",{"name":293,"class":135},"Assiut University",{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":303,"briefSummary":305,"conditions":306,"keywords":308,"overallStatus":284,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":4},"100648580","new-diagnostic-approaches-in-the-management-of-inflammatory-lung-diseases-100648580","NCT07723638","New Diagnostic Approaches in the Management of Inflammatory Lung Diseases","ALPI","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Diagnosis of chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), or combined pulmonary fibrosis and emphysema (CPFE), established according to current international diagnostic guidelines.\n* Ability and willingness to provide written informed consent.\n* Willingness to provide blood and saliva samples for biomarker analyses.\n* Willingness and ability to undergo clinical assessments and scheduled follow-up visits.\n* Willingness and ability to use study monitoring devices, including environmental monitoring devices and, where applicable, telemedicine tools.\n\nExclusion Criteria:\n\n* Age younger than 18 years.\n* Inability or unwillingness to provide written informed consent.\n* Inability to comply with study procedures or scheduled follow-up.\n* Presence of any medical, psychiatric, or cognitive condition that, in the opinion of the investigator, would interfere with study participation or interpretation of the study results.\n* Participation in another interventional clinical trial that, in the opinion of the investigator, could interfere with the objectives of this study.",{"count":302,"type":21},200,[304],"NA","Inflammatory lung diseases, including chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), are major causes of morbidity and mortality worldwide. Their development and progression are influenced by environmental exposures, such as cigarette smoking and air pollution, as well as genetic susceptibility. Despite advances in disease management, early diagnosis, accurate differential diagnosis, personalized treatment, and continuous monitoring remain significant clinical challenges.\n\nThis project aims to improve the management of inflammatory lung diseases through the development and validation of innovative diagnostic, monitoring, and therapeutic approaches. The study will identify and validate multi-omics biomarkers for the differential diagnosis and prognosis of COPD, IPF, and related respiratory diseases, using machine learning techniques to develop diagnostic and prognostic biochips. Environmental determinants, including indoor and outdoor exposome factors, will be assessed to better understand their contribution to pulmonary inflammation and disease progression. The project will also develop nanotechnology-based therapeutic formulations combined with precision inhalation devices and integrate a telemedicine platform for real-time monitoring of clinical and environmental data, enabling the early detection of exacerbations and supporting personalized disease management.\n\nThe expected outcomes include improved diagnostic accuracy, enhanced risk stratification, personalized therapeutic strategies, reduced disease exacerbations, and improved quality of life for patients with inflammatory lung diseases.",[307,27],"Chronic Obstructive Pulmonary Disease (COPD)",[309,310,31],"Biomarkers","COPD","2026-07-21",{"date":256,"type":38},{"date":314,"type":21},"2026-09-01",{"date":316,"type":21},"2027-11-13",{"name":318,"class":135},"Fondazione Don Carlo Gnocchi ETS",{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":329,"conditions":330,"keywords":331,"overallStatus":284,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":339,"leadSponsor":341,"locationsCount":94},"100648612","antifibrotic-therapy-decision-making-in-pulmonary-fibrosis-100648612","NCT07722507","Antifibrotic Therapy Decision-Making in Pulmonary Fibrosis","Understanding Pulmonary Fibrosis Through Web-Based Qualitative In-Depth Interviews on Antifibrotic TheRapy Decision-Making","UPWARD","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be eligible for inclusion in this study:\n\n1. Pulmonary fibrosis (PF) participants in Japan. Note: This includes those clinically recognized as having idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF).\n2. Participants who are ≥18 years of age at the time of providing informed consent via the web-based system.\n3. Participants receiving outpatient care for pulmonary fibrosis (PF) who have been introduced to this study by a referring physician.\n4. Participants who have a history of taking, or are currently taking, pirfenidone, nintedanib, or nerandomilast.\n5. Participants who have experienced at least one antifibrotic (AF) therapy-related adverse event (AE).\n\n   * Discontinuation group only\n\n1\\) Participants who have not received AF therapy for at least 1 month prior to enrollment.\n\n2\\) Participants whose AF therapy was discontinued within 6 months prior to enrollment.\n\n3\\) Participants whose reason for discontinuing AF therapy includes at least one AF therapy-related AE.\n\n* Continuation group only\n\n  1. Participants who feel or have felt burdened by the experienced AE.\n  2. Participants who have continued AF therapy for a specific period (≥6 months) at the time of enrollment.\n\n     Exclusion Criteria:\n\n     Participants meeting any of the following criteria will be excluded from the study:\n\n  \u003C!-- -->\n\n  1. Participants currently participating in any interventional clinical trials (regardless of the study drug, excluding observational studies).\n  2. Participants who have undergone lung transplantation.\n* Discontinuation group only 1) Participants who discontinued AF therapy solely for reasons other than AE (e.g., financial reasons, disease progression).",{"count":328,"type":21},40,"This study will explore how adults in Japan with pulmonary fibrosis decide whether to continue or discontinue antifibrotic therapy after experiencing antifibrotic therapy-related adverse events.",[30,27,62],[332,333,334,335],"Antifibrotic therapy","Pulmonary fibrosis (PF)","Idiopathic pulmonary fibrosis (IPF)","Progressive pulmonary fibrosis (PPF)","2026-07-20",{"date":256,"type":38},{"date":111,"type":21},{"date":340,"type":21},"2027-05-31",{"name":342,"class":45},"Bristol-Myers Squibb",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":354,"conditions":355,"keywords":356,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":94},"100632689","phase-2-a-study-to-find-an-efficacious-and-safe-dose-of-chf10067-zampilimab-in-participants-with-idiopathic-pulmonary-fibrosis-100632689","NCT07516951","A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis","A Phase IIb, Multicentre, Randomised, Double Blind, Placebo Controlled, Three-arm Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability at Week 24 of 2 Doses of CHF10067 (Zampilimab),in Participants With Idiopathic Pulmonary Fibrosis","ZAPPHIRE","Inclusion Criteria:\n\n* Informed consent: Participant's written informed consent obtained prior to any study-related procedure.\n* Sex and age: Male or female, of any race and ethnicity, aged ≥40 years with a life expectancy of at least 1 year at screening in the opinion of the Investigator.\n* Body weight ≥45 kg.\n* Diagnosis of IPF: Diagnosis as defined by the 2018 and 2022 American Thoracic Society\u002FEuropean Respiratory Society\u002FJapanese Respiratory Society\u002FLatin American Thoracic Society Guidelines for a maximum 8 years before screening. The most recent High-resolution computed tomography (HRCT) ≤6 months prior to screening, reviewed by central reading, should be used to confirm the diagnosis.\n* Lung function: FVC ≥45% of predicted normal value and a ratio of forced expiratory volume in the first second (FEV1)\u002FFVC ≥0.7 at screening.\n* Diffusing capacity of the lung for carbon monoxide (DLCO) corrected for haemoglobin ≥25% of predicted normal at screening.\n* Oxygen saturation measured by pulse oximetry (peripheral capillary oxygen saturation \\[SpO2\\]) \\>90% at rest when the maximum oxygen flow is 4 L\u002Fmin by standard nasal cannula or the equivalent oxygen delivery via reservoir nasal cannula (≤2 L\u002Fmin).\n\nExclusion Criteria:\n\n* Participant with a documented diagnosis of coeliac disease.\n* Low respiratory tract infection: Documented low respiratory tract infection in the last 4 weeks prior to screening or documented acute exacerbation of IPF (defined as acute worsening or development of dyspnoea typically \\\u003C1 month duration;\n* Lung cancer: Active diagnosis or history of lung cancer.\n* Emphysema: HRCT (refer to inclusion criterion \\[Diagnosis of IPF\\]), reviewed by central reading, shows the presence of emphysema ≥20% or that the extent of emphysema is greater than the extent of fibrosis.\n* Organ transplantation: End-stage fibrotic disease expected to require organ transplantation within 6 months from screening.\n* Other medical conditions: Clinically relevant and uncontrolled pulmonary (including any non-IPF pulmonary diagnosis), cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, psychiatric disorders, active or untreated latent tuberculosis\u002Ftuberculosis infection that may interfere with the participant's ability to complete this study according to the Investigator's judgement.\n* Any other comorbid non-IPF pulmonary condition that may impact FVC according to the Investigator's judgement. Emphysema is allowed, unless it meets the above exclusion criterion regarding emphysema.\n* Participant currently treated, or been treated with cytotoxic and immunosuppressant\u002Fmodulator drugs within 48 weeks prior to screening. Systemic (IV, intramuscular, or oral) corticosteroids prednisone- equivalent dose of \\>10 mg\u002Fday used for \\>10 days.\n* Hypersensitivity: Known intolerance and\u002For hypersensitivity to any of the excipients contained in the formulation or any other substance used in the study.\n* History of allergic or anaphylactic reaction to human, humanised, chimeric immunoglobulins (Igs), or murine monoclonal antibodies.",{"count":352,"type":21},240,[24],"The purpose of this study is to evaluate the efficacy, safety, and tolerability at Week 24 of 2 doses of CHF10067 (zampilimab) in participants with idiopathic pulmonary fibrosis (IPF).\n\nIt is a phase IIb, multicentre, randomised, double-blind, placebo-controlled, three-arm parallel-group study.\n\nA total of 240 participants with IPF (Idiomatic Pulmonary Fibrosis) will be randomised in approximately 150 investigational sites in North and Latin America, Europe, Asia, and Oceania.",[27],[31],"2026-07-15",{"date":359,"type":38},"2026-07-16",{"date":361,"type":38},"2026-07-08",{"date":363,"type":21},"2028-02-12",{"name":365,"class":45},"Chiesi Farmaceutici S.p.A.",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":22,"phases":376,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":388},"100644504","phase-3-idiopathic-pulmonary-fibrosis-ipf-related-chronic-cough-reduction-with-nalbuphine-extended-release-nal-er-tablets-100644504","NCT07671911","Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis","OCEAN-1","Inclusion Criteria:\n\n* Diagnosis of IPF as determined by the Investigator based on American Thoracic Society (ATS)\u002FEuropean Respiratory Society (ERS)\u002FJapanese Respiratory Society (JRS)\u002FLatin American Thoracic Society (ALAT) clinical practice guidelines.\n* Chronic cough for ≥8 weeks prior to Screening.\n* PGI-Severity Score ≥ 2 at Screening.\n* Forced vital capacity (FVC) ≥40 percent (%) of predicted at Screening.\n* Diffusing capacity for carbon monoxide (DLCO) ≥25% of predicted during Screening or within 12 weeks prior to Screening.\n* Participants who are currently taking antifibrotic medication (e.g., nintedanib, pirfenidone, nerandomilast) should be on a stable dose for at least 6 weeks prior to the Baseline Visit.\n\nExclusion Criteria:\n\n* Clinical diagnosis or clinical suspicion of an upper or lower respiratory tract infection in the last 8 weeks prior to the Screening visit or during Screening.\n* Hospitalization for any respiratory illness (including acute exacerbation of IPF) within 2 months prior to Screening.\n* Diagnosed sleep apnea or currently on any treatment for sleep apnea \\[example (e.g.), Continuous Positive Airway Pressure (CPAP)\\].\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":375,"type":21},306,[59],"The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with Idiopathic Pulmonary Fibrosis (IPF).",[27],"2026-07-09",{"date":381,"type":38},"2026-07-10",{"date":383,"type":38},"2026-06-29",{"date":385,"type":21},"2028-07",{"name":387,"class":45},"Trevi Therapeutics",5,{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":397,"targetDuration":399,"studyType":104,"phases":4,"briefSummary":400,"conditions":401,"keywords":404,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":94},"100469443","interstitial-lung-disease-research-unit-biobank-100469443","NCT05392881","Interstitial Lung Disease Research Unit Biobank","University of Kansas Medical Center Interstitial Lung Disease Research Unit (ILDRU) Biobank","ILDRU","Inclusion Criteria:\n\n1. The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP)\n2. The participant is being followed for the presence of autoimmune disease, ILD or other rare lung diseases at TUKHS.\n3. The participant is ≥ 18 years of age.\n4. The participant has signed an approved consent for this study (living patients only)",{"count":398,"type":21},1000,"10 Years","Establish a interstitial lung disease (ILD) registry and biorepository to lead towards a further understanding of the disease.",[221,402,27,30,403],"Sarcoidosis","Hypersensitivity Pneumonitis",[221,402,27,30,403],{"date":381,"type":38},{"date":407,"type":38},"2021-08-09",{"date":409,"type":21},"2032-03-01",{"name":411,"class":135},"University of Kansas Medical Center",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":422,"conditions":423,"keywords":424,"overallStatus":284,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":435},"100646704","phase-3-study-evaluation-rentosertib-ins018055-administered-orally-in-patients-with-idiopathic-pulmonary-fibrosis-ipf-100646704","NCT07687459","Study Evaluation Rentosertib (INS018_055) Administered Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF)","A Prospective Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Rentosertib (INS018_055) Administered Orally Over 52 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF)","Inclusion Criteria:\n\n1. An informed consent form (ICF) signed and dated at screening (Visit 1), prior to initiation of any study related procedures, and in accordance with ICH-GCP and local legislation.\n2. Patients aged ≥40 years at time of signing the ICF.\n3. Diagnosis of IPF based on the 2022 ATS\u002FERS\u002FJRS\u002FALAT Clinical Practice Guideline, confirmed by an HRCT chest scan within 3 months prior to screening visit.\n4. UIP or probable UIP with fibrosis extent \\>10% at HRCT.\n5. Meet all the following criteria during the screening period:\n\n   1. FVC ≥45% predicted of normal\n   2. FEV1\u002FFVC ≥0.7\n   3. DLCO (corrected for hemoglobin) ≥25% and \\\u003C80% predicted of normal.\n6. Background antifibrotic therapies are allowed, patients may be either:\n\n   1. on a stable therapy with nintedanib or pirfenidone as monotherapy for at least 12 weeks prior to screening visit and during the screening period and are planning to stay on this background treatment after randomization.\n   2. not on a treatment with nintedanib or pirfenidone for at least 8 weeks prior to screening visit and during the screening period and do not plan to start or restart antifibrotic therapy.\n7. Estimated minimum life expectancy of at least 30 months for non-IPF related disease in the opinion of the investigator.\n8. Male patients and female patients of childbearing potential agree to use highly effective contraception\u002Fpreventive exposure measures from the time of the first dose of the study drug (for the male patient) or the signing of the ICF (for the female patient) until 90 days after the last dose of the study drug.\n\nExclusion criteria:\n\n1. Interstitial lung disease associated with known primary diseases (eg, autoimmune disease-related interstitial lung diseases, sarcoidosis and amyloidosis), exposures (eg, radiation, silica, asbestos, and coal dust), or drugs (eg, amiodarone).\n2. Previous participation in a clinical study with rentosertib (active or placebo).\n3. Concurrent participation in another interventional drug, device, or biological investigational research study, or use of an investigational agent within 5 half-lives of the agent (or within 8 weeks when half-life is unknown) prior to screening is not allowed.\n4. Pulmonary hypertension that is clinically relevant or severe as deemed by the investigator, or other clinically significant pulmonary abnormalities.\n5. Unstable cardiovascular or other disease within 6 months prior to the screening visit or during the screening period.\n6. Presence of other clinically significant airway disease that may, in the opinion of the investigator, impact the study safety or efficacy objectives, such as asthma, bronchiectasis, cystic fibrosis, active aspergillosis, active tuberculosis, or other serious concomitant respiratory disorder other than pulmonary fibrosis.\n7. Acute exacerbation of IPF within 6 months prior to screening visit and\u002For during the screening period.\n8. Patients with underlying chronic liver disease (Child Pugh A, B, or C hepatic impairment), hepatic steatosis (including non-alcoholic steatohepatitis and\u002For other types of fatty liver diseases).\n9. Patients with Gilbert's disease\n10. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and clinically significant viral hepatitis.\n11. Aspartate aminotransferase or alanine aminotransferase ≥1.5 × upper limit of normal (ULN), and\u002For total bilirubin ≥1.5 × ULN, and\u002For gamma glutamyl transferase ≥3 × ULN, and\u002For alkaline phosphatase ≥1.5 × ULN at screening.\n12. Estimated glomerular filtration rate \\\u003C60 mL\u002Fmin\u002F1.73m2 at screening.\n13. Patient with 12-lead ECG demonstrating corrected QT interval by Fridericia (QTcF) \\>450 ms for males and \\>470 ms for females at screening (Visit 1).\n14. Patient with a history of lung volume reduction surgery or lung transplant.\n15. Current smoker and\u002For cotinine (smoking) test positive.\n16. History of drug abuse, drug use, or alcohol abuse within the past 3 months.\n17. Major surgery performed within 3 months prior to screening visit, during the screening period, or have major surgery planned during the study period.\n18. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening visit.\n19. Use of any of the following therapies within 4 weeks prior to screening visit and during the screening period or planned during the study: warfarin and immunosuppressive medications.\n20. Patients currently taking endothelin receptor antagonists,phosphodiesterase type 5 inhibitors, soluble guanylate cyclase modulators, prostacyclin analogues and prostanoids, or activin signaling inhibitor.\n21. Patients currently on a treatment with nerandomilast within 8 weeks prior to screening visit and during the screening period.\n22. Use of any of the following drugs within 2 weeks prior to Visit 1\u002Fscreening or planned during the duration of the study\n\n    1. Strong and moderate cytochrome P450 3A4 or 1A2 inhibitors\u002Finducers\n    2. Medications associated with substantial risk for prolongation of corrected QT interval.\n23. Patients who have consumed grapefruit or grapefruit juice, pomelo, Seville orange or Seville orange-containing products within 48 hours before Day 1.\n24. Patients who used hormone replacement therapy in the 4 weeks prior to randomization. No hormone replacement therapy use is allowed during the study.\n25. Patients with known hypersensitivity or contraindications to serine\u002Fthreonine kinase inhibitors.\n26. Any condition that would interfere with the interpretation of study assessments or impair study participation.\n27. Any physical or psychological conditions or circumstance that, in the opinion of the investigator, may make a patient unsuitable for inclusion or unlikely or unable to complete the study or comply with study procedures and requirements.",{"count":420,"type":21},320,[59],"This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Rentosertib (INS018\\_055) administered orally in Patients with Idiopathic Pulmonary Fibrosis.\n\nThe purpose of this study is to evaluate if Rentosertib (INS018\\_055) works to treat patients with Idiopathic Pulmonary Fibrosis in adults. It will also learn about the safety of Rentosertib (INS018\\_055).\n\nIn this study, Rentosertib (INS018\\_055) will be compared to a placebo (a look-alike substance that contains no drug) to investigate if Rentosertib (INS018\\_055) works to treat Idiopathic Pulmonary Fibrosis.",[27],[249,425],"serine\u002Fthreonine kinase TNIK","2026-07-01",{"date":428,"type":38},"2026-07-07",{"date":430,"type":21},"2026-08-30",{"date":432,"type":21},"2029-10-30",{"name":434,"class":45},"InSilico Medicine Hong Kong Limited",47,{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":443,"sex":17,"minAge":55,"maxAge":121,"enrollmentInfo":444,"targetDuration":4,"studyType":22,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":94},"100553634","pilot-study-of-nitrate-rich-beetroot-juice-supplementation-in-patients-with-idiopathic-pulmonary-fibrosis-ipf-100553634","NCT06488638","Pilot Study of Nitrate-rich Beetroot Juice Supplementation in Patients With Idiopathic Pulmonary Fibrosis (IPF)","BEET-IPF","IPF Patients: Inclusion Criteria\n\n1. Patients aged 18-85 years with a prior specialist multidisciplinary team diagnosis of idiopathic pulmonary fibrosis (IPF) based on current established consensus guidelines.\n2. Medical Research Council (MRC) breathlessness grade 1-3\n3. Judged clinically stable for 3 months prior to recruitment by the investigator.\n\nIPF Patients: Exclusion Criteria\n\n1. Baseline spirometry with FEV1\u002FFVC ratio \\\u003C 0.7.\n2. Neoplastic disease undergoing treatment or active follow up.\n3. Presence of infection or exacerbation requiring hospitalization, within last 3 months.\n4. Current tobacco smoker or use of nicotine containing vapes (within 3 months)\n5. Current use of ambulatory or long-term oxygen therapy (LTOT).\n6. Peripheral oxygen saturations \\\u003C85% during 6-minute walk-test.\n7. Any condition which would prevent completion of cycle-ergometer testing, pulmonary function testing (PFT) or 6-minute walk testing as judged by the investigator.\n8. Participation in a pulmonary rehabilitation (PR) program in the last 3 months.\n9. Any condition excluding CPET based on the absolute contraindication as the ACCP\u002FATS guidelines 2003\n10. Positive pregnancy test in females of childbearing age.\n11. Symptomatic peripheral vascular disease\n12. Concomitant use of nitrate-based medicine or phosphodiesterase V inhibitors\n\nControls: Inclusion Criteria\n\n1\\) Age and sex-matched to participants in the IPF cohort. Note: the participants will be age-matched within a 5-year age bracket.\n\nControls: Exclusion Criteria\n\n1. Inability to give informed written consent.\n2. Malignancy (except localised squamous or basal cell skin carcinoma) undergoing active investigation, treatment, or follow-up.\n3. Significant cardiorespiratory disease as judged by the investigator.\n4. Diabetes mellitus requiring treatment with pharmacology therapy.\n5. Current tobacco smoker or use of nicotine containing vapes (within three months).\n6. Symptomatic peripheral vascular disease.\n7. Concomitant use of nitrate-based medicine or phosphodiesterase V inhibitors.",true,{"count":445,"type":21},16,[304],"Idiopathic pulmonary fibrosis (IPF) is a type of scarring (fibrotic) lung disease. Reduced exercise capacity is a key symptom experienced by patients. In previous research the investigators identified that an interval-based exercise programme led to significant improvements in exercise capacity (Wallis et al Antioxidants. 2023).\n\nAn unexpected finding was that in patients with IPF, exercise led to a reduction in blood nitrite concentrations an observation the investigators did not see in non-affected individuals. Research has identified that nitrite concentrations are expected to increase after exercise and the size of this increase is related to an individual's exercise capacity. There is also evidence from healthy individuals and patients with chronic obstructive pulmonary disease (COPD) that nitrate supplementation (a source of nitrite) improves response to exercise training. However, in both these groups an exercise-induced fall in blood nitrite concentrations has not been observed. Hence our finding of an exercise-induced fall in blood nitrite levels in IPF patients suggest that they may be especially sensitive to supplementation with nitrate, commercially available as nitrate-rich beetroot juice (NRBJ).\n\nThis current study investigates this in a pilot placebo-controlled, double-blind, randomised, cross-over study of NRBJ on exercise capacity in IPF patients.\n\nAims In patients with IPF\n\n* Quantify the effect of nitrate supplementation on exercise capacity\n* Determine the effect of nitrate supplementation on blood markers of nitric oxide production\u002Fmetabolism.\n* Determine the effect of nitrate supplementation on forearm blood flow. Sample size: n=8 IPF patients, aged 18-85years and medical research breathlessness scale 1-3 Intervention: 3-days (two-times daily) NRBJ or nitrate-depleted placebo juice (both commercially available) with subsequent constant-load exercise test (Primary outcome). Following at least 1 week wash-out period participants will cross-over and repeat.\n\nA cohort (n=8) of age, sex-matched controls without IPF will be enrolled for comparison of forearm blood flow and pre-exercise venous blood samples for biomarkers comparison only.\n\nNumber of sites: 1",[27,221],{"date":450,"type":38},"2026-07-06",{"date":452,"type":38},"2026-02-13",{"date":454,"type":21},"2027-06-03",{"name":456,"class":135},"University Hospital Southampton NHS Foundation Trust",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":121,"enrollmentInfo":465,"targetDuration":4,"studyType":22,"phases":467,"briefSummary":468,"conditions":469,"keywords":470,"overallStatus":284,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":479},"100644927","phase-2-autoantibody-reduction-therapy-for-progressive-idiopathic-pulmonary-fibrosis-100644927","NCT07674745","Autoantibody Reduction Therapy for Progressive Idiopathic Pulmonary Fibrosis","Study of Therapeutic Plasma Exchange, Rituximab, and Intravenous Immunoglobulin for Progressive Idiopathic Pulmonary Fibrosis (STRIVE II)","STRIVE II","Inclusion Criteria:\n\n1. Age between 40-85 years old.\n2. A diagnosis of IPF that fulfills latest ATS\u002FERS Consensus Criteria.\n3. A diagnosis of Progressive IPF (P-IPF), defined as a relative decrease of FVC%p \\>10% during the preceding twelve months, and substantiated by replicate values at least three weeks apart.\n4. Ability and willingness to give informed consent (no surrogates) and adhere to requirements.\n5. Have eligibility confirmed by a consensus of trial investigators.\n6. Is not now or has been in experimental regimen for at least 2 weeks (or 5 half-lives of agent) and agrees to not become participants in other experimental regimens (other than solely observational registries) for the duration of their participation in this trial (180 days).\n7. Has been immunized with 2025-2026 COVID-19 vaccine (and later versions as they become available) between 1 and 26 weeks prior to randomization.\n8. IPF duration \\\u003C10 years, based on the date of definitive diagnosis.\n9. Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1\u002FFVC) \\>0.70\n\nExclusion Criteria:\n\n1. Diagnoses of current infection by clinical or microbial assessments.\n2. Diagnoses of an additional or alternative etiology for lung dysfunction based upon clinical assessment, including sepsis, congestive heart failure, thromboembolism, worsened pulmonary artery hypertension, etc. using routine clinical evaluations under direction of the attending physician.\n3. History or serologic evidence of hepatitis B or C infection. Positive serology for Hepatitis C will not exclude patients if their circulating HC virus RNA test is negative.\n4. Coagulopathy, defined as an INR \\>1.6, PTT \\>2x control, fibrinogen \\\u003C100 mg\u002FdL, or platelet count \\\u003C50,000 unless these abnormalities can be reversed.\n5. Uncontrolled diabetes or hypertension (systolic BP \\>160 mm Hg and diastolic BP \\>100 mm Hg) that would contraindicate use of corticosteroids.\n6. Hemodynamic instability, defined as an inotrope or vasopressor requirement.\n7. History of reactions to blood products, murine-derived products, or prior rituximab use within the last six months.\n8. History of malignancy, excluding basal or squamous cell skin cancer and low-risk prostate cancer, the latter defined as stage T1 or T2a, with prostate specific antigen \\\u003C10 ng\u002Fdl. AART is not known to promote cancer, and these criteria are within current guidelines.\n9. Unwillingness to accept blood product transfusion.\n10. Diagnosis of major comorbidities expected to interfere with study participation.\n11. Treatment for \\>14 days within the preceding month with \\>20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular immuno-suppressant (e.g., cyclophosphamide, methotrexate, calcineurin inhibitors, etc.), or with rituximab (or other anti-B-cell biological agents) within the last 6 months.\n12. Current treatment with an angiotensin converting enzyme inhibitor that cannot be discontinued and\u002For substituted (to obviate hemodynamic lability during TPE).\n13. Fertile women who do not agree to contraception or abstinence. IPF is a disease of older adults, and male predominant, so this will not be a frequent consideration.\n14. An alternative, concordant or historical diagnosis of interstitial lung diseases other than IPF, including idiopathic fibrosis with autoimmune features (IPAF) per clinical domain.1\n15. IgA deficiency, to preclude IVIg reactions.\n16. Listed with the United Network for Organ Sharing (UNOS) for lung transplant at the time of enrollment, to minimize the number of censoring due to very early transplants.\n17. Ongoing suspected or known acute exacerbations of IPF (AE-IPF), defined as new onset (within the last 30 days) of dyspnea with increased hypoxemia or oxygen requirement, and new radiographic infiltrates especially with ground glass opacities (GGO).\n18. Patients taking antifibrotic agents at randomization who have not been on a stable dose for at least 6 weeks: these therapies could be initiated, at the discretion of their attending physicians, at or after the midpoint of their participation in STRIVE II (i.e., three months after randomization).\n19. Patients whose oxygen requirements at rest (per an arterial oxygen saturation \\[SaO2\\] \\>0.92) cannot be met with simple nasal cannula at \\\u003C10L\u002Fmin.\n20. Patients who are not expected to survive 180 days or, in the opinion of the local attending physician, have a high likelihood of not tolerating the trial interventions due to underlying comorbidities or frailties.\n21. \\>10% of whole lung images are emphysematous on High Resolution CT scan\n\n    \\-",{"count":466,"type":21},52,[24],"This Phase IIb trial will compare effectiveness and safety of a multi-component autoantibody reduction therapy (AART), consisting of therapeutic plasma exchange (TPE), rituximab, and intravenous immunoglobulin (IVIg) for treatment of patients with progressive idiopathic pulmonary fibrosis (IPF).",[27],[471,472],"Progression","Autoantibodies",{"date":426,"type":38},{"date":475,"type":21},"2026-10-01",{"date":477,"type":21},"2031-03-31",{"name":134,"class":135},9,{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":443,"sex":487,"minAge":55,"maxAge":488,"enrollmentInfo":489,"targetDuration":4,"studyType":22,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":284,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":500,"leadSponsor":502,"locationsCount":94},"100645244","phase-1-study-of-single-and-multiple-oral-doses-of-scb0020160-in-healthy-adult-male-subjects-100645244","NCT07682337","Study of Single and Multiple Oral Doses of SCB0020160 in Healthy Adult Male Subjects","A First-in-Human, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Food Effect of SCB0020160 After Oral Administration in Healthy Adult Male Subjects","Inclusion Criteria:\n\n* Healthy adult male volunteers in the opinion of the principal investigator or delegate, aged 18 to 65 years at screening\n* Body weight more Than or equals to 45.0 kilograms per square meter at screening, with a body mass index (BMI) of more than or equals to18.0-kilogram Meter square and less than or equals to 32.0 Kilograms per meter square\n\n  * Body Mass Index (BMI, kilograms per square meter.) = Weight (kilogram)\u002F\\[Height square meter\\]\n* Eligible to participate in the study based on the results of physical examination, clinical laboratory tests, history taking, and other examinations performed at screening, as determined by the principal investigator or delegate\n* Has voluntarily decided to participate and provided written or electronic consent to comply with the precautions after receiving a full explanation of the study and fully understanding it\n\nExclusion Criteria:\n\n* Has a history of or currently has any disease, including clinically significant hepatobiliary (severe liver impairment, viral hepatitis, etc.), renal (severe renal impairment, etc.), neurological, immunological, respiratory, digestive, endocrine, hematologic and oncologic, cardiovascular (Torsades de pointes, etc.), urological, psychiatric (mood disorders, obsessive compulsive disorder, etc.), and sexual function disorders\n* Has a history of or currently has a gastrointestinal disease (Crohn's disease, ulcerative colitis, etc.) that may affect the safety and pharmacokinetic evaluation of the investigational product, or has a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery)\n* Has a history of hypersensitivity to the active pharmaceutical ingredient and components of the investigational product, drugs in the same class as the active pharmaceutical ingredient, or other drugs (aspirin, antibiotics, etc.)\n* Has genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption\n* Has any of the following results in vital signs measured in a sitting position after resting for at least 5 minutes at screening\n* Systolic blood pressure more than 80 millimeters of mercury or greater than or equal to140 mmHg\n* Diastolic blood pressure less than 45 millimeters of mercury or greater than or equal to140 mmHg 90 millimeters of mercury\n* Pulse rate less than 45 beats\u002Fmin or \\> 105 beats\u002Fmin\n* Has any of the following results in the 12-lead electrocardiogram measured in a semi-supine position after resting for at least 5 minutes at screening, or has clinically significant rhythm findings\n* QTcF less than 450 msec\n* Has any of the following results in the screening clinical laboratory tests\n* Estimated Glomerular Filtration Rate (eGFR) (CKD-EPI equation) \\\u003C 90 mL\u002Fmin\u002F1.73 m²\n* Fasting serum glucose more than 5.4 millimoles per liter. or less than 3.0 millimoles per liter.\n* AST or ALT 1.5 X the upper limit of normal (ULN)\n* Total cholesterol less than 5.5 millimoles per liter\n* Triglyceride less than 2.0 millimoles per liter.\n* Drinks alcohol persistently (less than 21 units\u002Fweek, 1 unit = 10 gram = 12.5 milli liter of pure alcohol) or is unable to refrain from alcohol consumption from 3 days prior to the expected first dose of the investigational product until the end of the study\n* Tested positive for the breath alcohol test at screening or at check-in on D-1 10) Smokers (However, those who quit smoking 3 months prior to the expected first dose of the investigational product may be eligible as subjects)\n* Tested positive for the urine cotinine test at screening or at check-in on D-1, even if they do not smoke\n* Has taken any prescribed drugs or herbal medicines within 2 weeks prior to the expected first dose, or has taken any over-the-counter (OTC) drugs, health functional foods including liver supplements, or vitamins within 1 week (However, they may participate in the study if the investigator deems their other conditions appropriate), or is expected to take any of the said agents\n* Has taken drugs that induce drug-metabolizing enzymes, such as barbiturates, or drugs that inhibit drug metabolism, such as clarithromycin, within 1 month prior to the expected first dose\n* Has a history of alcohol or drug abuse, or has shown a positive result for abused drugs in a urine drug test at screening or at check-in on D-1\n* Has participated in another study (including bioequivalence studies) and received an investigational product within 3 months prior to the first dose\n* Has donated whole blood within 2 months, donated blood components within 1 month, or received a blood transfusion within 1 month prior to the expected first dose\n* Has persistently consumed excessive amounts of caffeine (\\> 5 units\u002Fday, 1 unit = 80 mg of caffeine), or is unable to refrain from consuming caffeine-containing foods (coffee, tea (black tea, green tea, etc.), carbonated beverages, coffee-flavored milk, health tonics, energy drinks, etc.) from 3 days prior to the expected first dose of the investigational product until the end of the study\n* Has consumed grapefruit, grapefruit juice, or grapefruit-containing foods from 3 days prior to the expected first dose of the investigational product until the end of the study, or is unable to refrain from consuming grapefruit-containing foods during this period\n* Has unusual eating habits (e.g., consuming more than 1L of grapefruit juice per day) or is unable to consume the standard diet provided by the study site during the inpatient period\n* Tested positive for serological tests (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)\n* Subjects who, or whose spouse (or partner) is a woman of childbearing potential, are unable or unwilling to use methods of contraception considered highly effective for the entire period of the study and for at least 90 days after the last dose of the investigational product, and who do not agree to avoid donating sperm\u002Feggs during this period.\n\n\\[Methods of contraception considered highly effective\\]\n\n* Intrauterine devices and intrauterine hormone-releasing systems with a proven contraception failure rate (\\\u003C 1%\u002Fyear) plus the use of a male condom\n* Bilateral tubal occlusion or bilateral tubal ligation plus the use of a male condom\n* Azoospermia is confirmed by sperm test after vasectomy\n* Hormonal contraception (e.g., combined oral contraceptive, progestogen-only oral contraceptive), contraceptive patch, vaginal ring, injection, subdermal contraceptive implant); however, hormonal contraception is limited to cases where it is being used for 28 days or longer prior to the administration of the investigational product and can be continuously used during the study period and up to 90 days after the last dose plus the use of a male condom.\n* Sexual abstinence, if it is the usual and preferred method of contraception.\n* Those judged by the principal investigator or delegate to be ineligible for participation in the study for reasons other than the above-mentioned criteria (non-compliance with instructions, etc.)","MALE","65 Years",{"count":490,"type":21},74,[125],"This study aims to evaluate the safety, tolerability, pharmacokinetics, and food effect of a new investigational medicine called SCB0020160 in healthy adult men. This is the first time SCB0020160 will be administered to humans.\n\nHealthy adult men aged 18 to 65 years who meet the study eligibility criteria.\n\nStudy details\n\nParticipants will be randomly assigned to receive either SCB0020160 or placebo. The study includes single-dose and multiple-dose treatment periods, as well as an assessment of the effect of food on the absorption of SCB0020160.\n\nParticipants will undergo safety assessments including physical examinations, vital signs, ECGs, blood and urine tests, and monitoring of adverse events. The study will also assess how SCB0020160 is processed by the body.\n\nThere is no direct health benefit expected from participation. The results may help determine safe dose levels and support future clinical development of SCB0020160.",[494,495,27],"Solid Tumor","Obesity","2026-06-26",{"date":498,"type":38},"2026-07-02",{"date":383,"type":21},{"date":501,"type":21},"2027-07-01",{"name":503,"class":45},"SCBIO Inc.",{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":443,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":512,"conditions":513,"keywords":516,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":94},"100092968","a-study-of-the-natural-progression-of-interstitial-lung-disease-ild-100092968","NCT00470327","A Study of the Natural Progression of Interstitial Lung Disease (ILD)","Inclusion Criteria:\n\n* Interstitial lung disease\n\nExclusion Criteria:\n\n* Does not have Interstitial lung disease",{"count":511,"type":21},4000,"We propose to acquire data and blood samples on all patients being cared for by the Interstitial Lung Disease (ILD) program. Additionally, we will collect data and blood samples from a control group for comparator purposes. In doing so, we will be able to describe the \"phenotypic\" expression of these diseases.",[514,27,402,515],"Interstitial Lung Diseases","Connective Tissue Disorder",[517,518,402,519],"Interstitial lung diseases","idiopathic pulmonary fibrosis","mRNA and cytokine expression","2026-06-05",{"date":522,"type":38},"2026-06-09",{"date":524,"type":38},"2005-09",{"date":526,"type":21},"2030-12",{"name":528,"class":135},"University of Chicago",{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":22,"phases":538,"briefSummary":539,"conditions":540,"keywords":4,"overallStatus":284,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":545,"leadSponsor":547,"locationsCount":4},"100637831","phase-2-a-phase-ii-study-to-evaluate-the-efficacy-and-safety-of-syh2059-tablets-in-adult-patients-with-idiopathic-pulmonary-fibrosis-100637831","NCT07600021","A Phase II Study to Evaluate the Efficacy and Safety of SYH2059 Tablets in Adult Patients With Idiopathic Pulmonary Fibrosis","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SYH2059 Tablets in Adult Patients With Idiopathic Pulmonary Fibrosis.","Inclusion Criteria:\n\n* 1\\. Age ≥ 40 years, regardless of gender;\n* 2\\. The investigator confirms the clinical diagnosis of IPF in participants based on chest HRCT, surgical lung biopsy, or transbronchial lung cryobiopsy (if available) performed during the screening period or within 1 year prior to screening (see Appendix 13.7 for details);\n* 3\\. FVCpp ≥ 45% during the screening period;\n* 4\\. Hemoglobin-corrected DLCOpp ≥ 25% and \\\u003C 90% during the screening period;\n* 5\\. Received a single stable-dose antifibrotic therapy for at least 12 weeks prior to screening (concurrent use of nintedanib and pirfenidone is prohibited) and will continue after randomization; or had not received stable antifibrotic therapy, or had discontinued such therapy for at least 8 weeks, with no plan to initiate antifibrotic therapy during the trial;\n* 6\\. Understands the purpose and risks of this study, comprehends and agrees to comply with all study procedures, consents to participate, and provides written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Interstitial lung disease other than IPF.\n* 2\\. Airway obstruction during screening (FEV₁\u002FFVC \\\u003C 0.7), or emphysema greater than pulmonary fibrosis on HRCT.\n* 3\\. Confirmed or suspected acute exacerbation of IPF within 3 months prior to screening.\n* 4\\. Investigator judgment that IPF severity showed sustained improvement during the 12 months prior to screening, based on changes in FVC, DLCO and\u002For HRCT findings.\n* 5\\. Other clinically significant respiratory diseases during screening.\n* 6\\. Severe diseases in any other system (cardiovascular, digestive, neurological, hematological, endocrine) during screening.\n* 7\\. Malignancy within 5 years prior to screening (excluding treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin, or carcinoma in situ of the cervix).\n* 8\\. Any acute infection within 2 weeks prior to screening that has not fully recovered per investigator judgment.\n* 9\\. Active, unstable or uncontrolled vasculitis within 8 weeks prior to screening.\n* 10\\. Any acute or chronic active infection during screening.\n* 11\\. C-SSRS assessment during screening indicating suicidal behavior within the past 2 years (actual attempt, interrupted attempt, aborted attempt, or preparatory acts or gestures), or clinically significant suicidal ideation within 3 months prior to screening or during screening (participant answered \"yes\" to C-SSRS suicidal ideation question 4 or 5).\n* 12\\. Treatment with PDE1, PDE3, PDE4, PDE10 inhibitors, or non-selective PDE inhibitors within 4 weeks prior to screening.\n* 13\\. Use of strong CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of investigational product, or inability to discontinue such agents during the study.\n* 14\\. Receiving immunomodulatory agents (excluding oral glucocorticoids) for respiratory or pulmonary conditions during screening, or prednisone (or equivalent) at a daily dose \\> 15 mg.\n* 15\\. Abnormal hepatic and renal function during screening: ALT, AST \\> 2.5 × ULN, or TBIL \\> 1.5 × ULN, or eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m².\n* 16\\. Severe, persistent, uncontrolled hypertension during screening (SBP ≥ 180 mmHg or DBP ≥ 100 mmHg).\n* 17\\. History of smoking within 3 months prior to screening or unwillingness to abstain from smoking (including e-cigarettes) during the study.\n* 18\\. Hypersensitivity to SYH2059 or any excipients, or history of severe drug allergy.\n* 19\\. Participation in any clinical trial within 4 weeks prior to screening (excluding those not receiving investigational product).\n* 20\\. Participation in a clinical study of the same target drug and receipt of treatment within 3 months prior to screening.\n* 21\\. Pregnant or lactating females; fertile females or males unwilling to practice strict contraception throughout the trial and for 3 months after trial completion until the end of the safety follow-up period (including male participants).\n\nAny other conditions deemed inappropriate for trial participation by the investigator.\n\n* 22\\. Additional Exclusion Criteria (for PK intensive sampling participants):\n* 23\\. Previous history of gastrointestinal surgery that may interfere with the PK of the investigational product.\n* 24\\. Alcohol consumption exceeding 14 units per week within 4 weeks prior to screening.\n* 25\\. Habitual excessive intake of xanthine- or caffeine-containing foods, beverages, or other substances affecting drug absorption, distribution, metabolism or excretion within 4 weeks prior to screening.",{"count":537,"type":21},156,[24],"This is a multicenter, randomized, double-blind, placebo-controlled Phase II study. It Aims aims to evaluate the efficacy and safety of different doses of SYH2059 tablets compared with placebo in adult patients with IPF, observe the PK profile of SYH2059 tablets in adult IPF patients, and assess the population pharmacokinetic (PPK) profile, exposure-response (E-R) relationship, as well as the changing trends of blood biomarkers.",[27],"2026-05-14",{"date":543,"type":38},"2026-05-20",{"date":260,"type":21},{"date":546,"type":21},"2027-12-30",{"name":548,"class":45},"InnovStone Therapeutics Limited",{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":443,"sex":17,"minAge":556,"maxAge":488,"enrollmentInfo":557,"targetDuration":4,"studyType":22,"phases":558,"briefSummary":559,"conditions":560,"keywords":561,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":575},"100627873","phase-1-a-study-to-evaluate-pharmacokinetics-and-drug-drug-interactions-of-env-101-taladegib-in-healthy-participants-100627873","NCT07454291","A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants","A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 in Healthy Participants","Inclusion Criteria:\n\n* Participants are reproductively sterile.\n* Body Mass Index (BMI) ≥ 18.5 and ≤ 32 kg\u002Fm2 and body weight ≥ 50 kg at study start.\n* Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or electrocardiograms (ECGs) prior to dosing, as deemed by the Investigator.\n* Able to swallow multiple capsules and tablets.\n* Participants are willing to remain on study treatment for the duration of the study and comply with all study days and procedures.\n* Participants willing to sign and have a full understanding of the informed consent.\n* Participants must be willing to be sequestered for the time period indicated for their respective cohort.\n\nExclusion Criteria:\n\n* Chronic or current use of any prescription or over the counter medications; or acute use of prescription medications within 14 days or 5 half-lives, whichever is longer, or over the counter medications within 7 days or 5 half-lives, whichever is longer, prior to study start, or planned use during all study periods.\n* Participant is unwilling to refrain from fruits (including juices) that inhibit CYP3A4, including grapefruit, Seville orange, pomelo, or star fruit, beginning 7 days prior to study start through end of study.\n* Active infection with hepatitis B or C, or human immunodeficiency virus (HIV) during screening.\n* Current alcohol or drug abuse.\n* Smoking or other nicotine use (including but not limited to vaping, nicotine patch, nicotine gum or nicotine lozenge) within 3 months prior to screening, current smoker, or unwillingness to refrain from smoking for the duration of the study.\n* History or presence (per participant history) of:\n\n  1. Autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus\n  2. Thrombophlebitis or deep vein thrombosis\n  3. Hematologic or coagulation disorders\n  4. Liver disease or dysfunction; Gilbert's syndrome\n  5. Renal dysfunction or glomerulonephritis\n  6. Coronary artery disease\n  7. Diverticular disease\n  8. Congestive heart failure or ventricular dysfunction\n  9. Clinically significant cardiovascular, gastrointestinal, pulmonary, endocrine, central nervous system disorders, or other major active and uncontrolled disease in the opinion of the Investigator.\n* History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers, within 5 years before study start.\n* Participation in a clinical research trial that included the receipt of an investigational agent or any experimental procedure within 30 days or 5 half-lives, whichever is longer, prior to screening, during screening, or planned participation in any such trial while participating in this study.\n* Major surgery requiring hospitalization (according to the Investigator) performed within 3 months prior to screening, or planned during the course of the trial.\n* Participants with clinically significant cardiac abnormalities including but not limited to: has pacemaker; or is not in sinus rhythm during screening; or has a left bundle branch block or bifascicular block during screening; or any prior history of ventricular arrhythmia or torsades de pointes.\n* Participant is unwilling to adhere to the on-study diet provided by the clinical site during study participation.\n* Females who are pregnant or nursing.\n* Participants that are unwilling to refrain from blood or blood product donation for the duration of the study and for 30 days after their final dose of any study treatment.\n* Males who are unwilling to refrain from sperm donation for the duration of the study and for 95 days after their final dose of any study treatment.\n* Females who are unwilling to refrain from egg donation for the duration of the study and for 95 days after their final dose of any study treatment.\n* Participants with a history of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of taladegib (all cohorts), nintedanib (Cohort 1), or pirfenidone (Cohorts 2 and 3).\n* Participants who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study investigative site or the study Sponsor.","26 Years",{"count":5,"type":21},[125],"The purposes of this study are to:\n\n1. evaluate potential interactions between taladegib (ENV-101) and current standard-of-care (SOC) therapies for idiopathic pulmonary fibrosis (IPF), including nintedanib and pirfenidone, and\n2. more fully characterize the pharmacokinetics (PK) of taladegib (i.e., how the body absorbs, distributes, metabolizes and excretes taladegib).\n\nThis study will enroll 4 cohorts (groups) of participants. Each cohort will experience a different duration of treatment and sequestering (being housed) at the clinical site, followed by a 14-day follow-up period for safety evaluation. The longest duration of treatment for any cohort is 30 days.",[27],[562,563,564,565],"ENV-101","taladegib","drug-drug interaction","pharmacokinetics","2026-05-13",{"date":568,"type":38},"2026-05-15",{"date":570,"type":38},"2026-04-28",{"date":572,"type":21},"2026-10",{"name":574,"class":45},"Endeavor Biomedicines, Inc.",2,{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":443,"sex":17,"minAge":18,"maxAge":243,"enrollmentInfo":583,"targetDuration":4,"studyType":22,"phases":584,"briefSummary":585,"conditions":586,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":589,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":94},"100347151","skeletal-muscle-function-in-interstitial-lung-disease-100347151","NCT03800017","Skeletal Muscle Function in Interstitial Lung Disease","Investigating the Role of Skeletal Muscle Dysfunction on Dyspnea and Exercise Intolerance in Interstitial Lung Disease","Inclusion Criteria for ILD Patients:\n\n* Age 40-80 years (inclusive)\n* A multidisciplinary diagnosis of idiopathic pulmonary fibrosis (IPF), idiopathic fibrotic nonspecific interstitial pneumonia (NSIP), chronic hypersensitivity pneumonitis (HP), or unclassifiable ILD with a differential diagnosis that consists of the above diagnoses\n* Fibrosis on high resolution computed tomography (HRCT): honeycombing, reticulation, or traction bronchiectasis\n* Appropriate candidate for pulmonary rehabilitation\n* 6 minute walk distance 50m or more\n* Oxygen saturation ≥ 92% by pulse oximetry at rest while breathing room air\n* Clinically stable for the preceding 6 weeks\n* Can fluently read and write in English\n\nInclusion Criteria for Healthy Controls:\n\n* Age 40-80 (inclusive)\n* Normal pulmonary function (80-120% predicted)\n* No lung or cardiovascular disease\n* Can fluently read and write in English\n\nExclusion Criteria for the ILD patients:\n\n* Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease)\n* Other significant extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and\u002For oxygenation\n* Forced vital capacity (FVC) less than 50% or Diffusion capacity for carbon monoxide (DLCO) less than 25%\n* Concurrent or recent participation (less than 6 months) in a pulmonary rehabilitation program\n* Use of prednisone greater than 10 mg\u002Fday for more than 2 weeks within 3 months of the first study visit\n* Significant emphysema (less than 10% volume on HRCT or FEV1\u002FFVC less than 0.70)\n\nExclusion Criteria for Healthy Controls:\n\n* Currently smoking or previously smoked more than 10 pack-years\n* Any medical conditions that prevents them for exercising safely\n* Cardiac pacemaker or any metal or electronic inside the body",{"count":328,"type":21},[304],"Dyspnea (i.e. breathlessness) and exercise intolerance are common symptoms for patients with interstitial lung disease (ILD), yet it is not known why. It has been suggested that muscle dysfunction may contribute to dyspnea and exercise intolerance in ILD. Our study aims to: i) examine differences in the structure and function of the leg muscles in ILD patients, ii) determine if leg muscle fatigue contributes to dyspnea and exercise limitation in patients with ILD, and iii) determine the effects of breathing extra oxygen on leg muscle fatigue, as well as ability to exercise in ILD patients.",[221,27,403,587,588],"Scleroderma","Nonspecific Interstitial Pneumonia",{"date":568,"type":38},{"date":591,"type":38},"2024-08-07",{"date":593,"type":21},"2026-12-31",{"name":595,"class":135},"University of British Columbia",{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":601,"acronym":4,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":243,"enrollmentInfo":603,"targetDuration":4,"studyType":22,"phases":604,"briefSummary":605,"conditions":606,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":575},"100504008","azithromycin-in-the-management-of-patients-with-acute-exacerbation-of-idiopathic-pulmonary-fibrosis-100504008","NCT05842681","Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis","Role of Add-on Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis","Inclusion Criteria:\n\n* Baseline disease severity classified as mild or early-moderate according to the SCALE-IPF (locked April 2023) threshold ≤ 13 points.\n* Participation within the Assiut University IPF Research Program (2022-2026).\n* Additional longitudinal therapeutic platform arms involving pirfenidone with or without azithromycin may include clinically stable idiopathic pulmonary fibrosis patients according to protocol-amended eligibility criteria approved in September 2025.\n\nExclusion Criteria:\n\n* Age: less than 18 years.\n* Patients with any severity other than mild or early-moderate acute exacerbation of IPF according to SCALE-IPF (locked April 2023).\n* Patients with multislice computed tomography with a radiological pattern rather than usual interstitial pneumonitis (UIP).\n* Unstable patients need mechanical ventilation or Respiratory Intensive Care Unit admission.\n* Patients with end-organ failure.\n* Patients with known hypersensitivity or contraindication to pirfenidone or azithromycin, significant hepatic impairment, severe drug intolerance, or other contraindications to study medications according to standard clinical judgment.",{"count":398,"type":21},[304],"This randomized controlled trial evaluates the therapeutic role of azithromycin in acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF). Baseline severity classification and stratification were performed using the SCALE-IPF framework (Severity Classification and Lung Evaluation for Prognosis in IPF; locked April 2023) to ensure balanced disease severity across randomized arms. End-of-study analyses included descriptive and stratified phenotyping using the Idiopathic Pulmonary Fibrosis Phenotypes Identification Model (IPIM); locked April 2023).\n\nFollowing a protocol amendment approved in September 2025, the study expanded into a multi-arm therapeutic platform evaluating both azithromycin timing strategies and combination antifibrotic-immunomodulatory therapy in idiopathic pulmonary fibrosis. Additional treatment arms involving pirfenidone with or without azithromycin were incorporated without altering the original randomized comparisons or baseline study framework.\n\nBoth frameworks were developed within the Assiut University IPF Research Program (2022-2026), a coordinated institutional effort investigating clinical, prognostic, and therapeutic dimensions of IPF. Neither framework altered randomization procedures, treatment allocation, or study endpoints; they were applied to improve standardization, reproducibility, and interpretability of results.",[27],"2026-05-11",{"date":566,"type":38},{"date":610,"type":38},"2023-06-01",{"date":612,"type":21},"2027-02-28",{"name":293,"class":135}]