[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pulmonary-sarcoidosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pulmonary-sarcoidosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,77,98,123],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100645332","phase-1-a-seamless-adaptive-multiple-ascending-dose-and-efficacy-study-of-xtmab-16-in-patients-with-pulmonary-sarcoidosis-with-or-without-extrapulmonary-manifestations-100645332",false,"NCT07680166","A Seamless, Adaptive Multiple-Ascending-Dose and Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations","Inclusion Criteria:\n\n1. Participant between 18 and 80 years (inclusive) of age.\n2. Weighs between 45 and 160 kg (99 to 353 lbs) at Screening.\n3. Diagnosis of pulmonary sarcoidosis (at least 6 months before Screening) using the 2020 American Thoracic Society (ATS) Clinical Practice Guideline (Crouser et al, 2020), the European Respiratory Society (ERS) or the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) criteria including a compatible clinical and radiologic presentation with other causes of granulomatous disease ruled out (cutaneous and ocular involvement permitted).\n4. mMRC Dyspnea Scale of ≥1.\n5. Baseline pre-BD ppFVC of ≥ 50% during screening window, and confirmed at the Baseline visit prior to enrollment and dosing.\n6. Receiving corticosteroid treatment 5 to 25 mg\u002Fday of oral prednisone, or equivalent), during the screening period and, at the determination of the Investigator, is capable of undergoing the protocol specific corticosteroid taper regimen.\n7. Receiving treatment with methotrexate, azathioprine, mycophenolate, leflunomide, chloroquine, or hydroxychloroquine for at least 3 months before Screening that has been at a stable dose for 4 weeks before Screening. All efforts should be made to maintain stable background therapy at the Screening dose through the intervention period at the Investigator's discretion.\n8. Radiographic evidence of disease in the lung parenchyma (at least Scadding stage II disease) without the presence of significant fibrosis.\n\n   Note: Significant fibrotic disease is defined as fibrosis \\> 20% as determined by central read.\n9. Able to provide written informed consent.\n10. In the opinion of the Investigator, the participant is capable of understanding and complying with protocol requirements.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women or women who are planning to become pregnant during the study.\n2. Known potentially significant fibrotic disease and\u002For active inflammation contained solely in the hilar region as shown by HRCT, confirmed by a central reader. Participants with current active inflammation in the hilar region with concurrent inflammation outside the hilar region may be included. A historical HRCT performed within 6 months of screening may be submitted for diagnostic confirmation by central review. If a participant's last HRCT was from \\>6 months of screening, an HRCT should be performed during screening for diagnostic confirmation by central review. Note: Significant fibrotic disease is defined as \\>20% fibrosis on HRCT.\n3. Clinically significant extra-pulmonary sarcoidosis requiring systemic therapy as determined by the Investigator.\n4. Any therapy with an anti-TNFα monoclonal antibody (e.g., infliximab, adalimumab, golimumab and their biosimilars) within 6 months.\n5. Baseline pre-BD ppFVC of \\>85%.\n6. Prior treatment with rituximab or repository corticotropin injection within the previous 12 months.\n7. Clinically significant CNS sarcoidosis requiring therapy, except history of isolated seventh cranial nerve palsy or evidence of demyelinating neurologic disease.\n8. Advanced congestive heart failure (New York Heart Association 3 or 4).\n9. Current disease presentation consistent with Lofgren's syndrome (i.e., presence of the triad of erythema nodosum, bilateral hilar lymphadenopathy on chest X-ray, and joint pain).\n10. Clinically significant pulmonary hypertension requiring treatment. Note: Clinically significant pulmonary hypertension requiring treatment would be defined as treatment with, i.e., prostacyclins, phosphodiesterase 5 inhibitors, and endothelin receptor antagonists.\n11. Known hypersensitivity to any component of the formulation of XTMAB-16.\n12. Evidence of active or latent tuberculosis (TB) by interferon-gamma release assay (IGRA) or invasive fungal infections at Screening.\n13. Known positive history of malignancy other than non-melanomatous skin cancer in the last 2 years, including in-situ carcinoma of the uterine cervix completely cured by radical surgery.\n14. Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, coronavirus disease (COVID-19), TB, or a known history of human immunodeficiency virus (HIV) infection at Screening.\n15. Women of childbearing potential who are sexually active with a non-sterilized male partner and are not willing to adhere to highly effective birth control measures from the time of signing the informed consent, throughout the duration of the study, and for 90 days after 5 half-lives have elapsed since the last dose of study drug. See Appendix 4 for details on contraception requirements during the study.\n16. Male participants who are non-sterilized and sexually active with a female partner of childbearing potential and are not willing to use highly effective contraception from the time of signing the informed consent throughout the duration of the study, and for 90 days after 5 half-lives have elapsed since last dose of study drug. See Appendix 4 for details on contraception requirements during the study.\n17. Clinically significant hepatic or renal disease, including uncontrolled diabetes at the discretion of the Investigator.\n18. Any severe prior reaction to any type of biologics or human blood product such as albumin, immunoglobulin G (IgG), etc.\n19. Concurrent emphysema.\n20. Known hypercalcemia due to non-sarcoidosis conditions such as untreated hyperparathyroidism, at the discretion of the Investigator.\n21. Abnormal electrocardiogram (ECG): ventricular arrhythmias (non-sustained ventricular tachycardia (VT), multifocal or frequent premature ventricular contractions, bundle branch block, axis deviation, or abnormal Q waves). In the case of a corrected QT interval by Fredericia interval \\>450 ms (men) or \\>480 ms (women; participants with bundle branch block) or PR interval outside the range of 120 to 220 ms, the assessment may be repeated once for eligibility determination at Screening or Baseline.\n22. Donation or loss of 450 mL or more of his or her blood volume (including plasmapheresis) or transfusion of any blood product within 90 days prior to dosing.\n23. Known uncontrolled hypertension. Note: Uncontrolled hypertension is noted as blood pressure (BP) ≥160\u002F100 mmHg despite antihypertensive therapy within 3 months of randomization.\n24. Clinical signs and symptoms consistent with COVID-19, e.g., fever, dry cough, dyspnea, sore throat, fatigue, new smell or taste disorder or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening.\n25. In the opinion of the Investigator, inability to tolerate corticosteroid taper.\n26. Concurrent systemic steroid use for non-sarcoidosis conditions.\n27. Concurrent known auto-immune disease requiring treatment.\n28. Participation in another clinical trial of an investigational agent within 3 months (small molecule) \u002F 6 months (biologics) or 5 half-lives (if known) of the agent, whichever is longer.\n29. Any condition that required hospitalization within the 3 months prior to Day 1 or is likely to require so during the study.\n30. Clinically significant abnormalities in the Screening physical exam, medical history, vital signs, ECG, or clinical laboratory tests that are not known to be due to concurrent sarcoidosis, and in the opinion of the Investigator and Medical Monitor should preclude the participant's participation in the clinical study.","ALL","18 Years","80 Years",{"count":19,"type":20},182,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","A study of XTMAB-16 in patients with pulmonary sarcoidosis",[27],"Pulmonary Sarcoidosis","NOT_YET_RECRUITING","2026-06-25",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":20},"2026-10-30",{"date":36,"type":20},"2029-10-31",{"name":38,"class":39},"Xentria, Inc.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":15,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":4,"leadSponsor":73,"locationsCount":76},"100054548","role-of-genetic-factors-in-the-development-of-lung-disease-100054548","NCT00001532","Role of Genetic Factors in the Development of Lung Disease","Role of Genetic Factors in the Pathogenesis of Lung Disease","* INCLUSION CRITERIA:\n\nInclusion criteria for patients with AAT deficiency include: (1) Diagnosis of AAT with a confirmed phenotype considered in the high risk category; (2) Clinical phenotype consistent with potential genetic diseases and other genetic causes of lung diseases (3) symptoms consistent with pulmonary disease; (4) chest x-ray consistent with pulmonary disease; (5) pulmonary function tests consistent with pulmonary disease; (6) smokers, defined as individuals who are current smokers (1 pack per day for at least 2 years) and nonsmokers, defined as never-smokers or ex-smokers who have quit smoking three or more years ago;\n\nInclusion criteria for individuals with chronic obstructive pulmonary diseases include:\n\n1. symptoms consistent with pulmonary disease\n2. chest x-ray consistent with pulmonary disease\n3. pulmonary function tests consistent with pulmonary disease;\n4. smokers, defined as individuals who are current smokers (1 pack per day for at least 2 years) and nonsmokers, defined as never-smokers or ex-smokers who have not smoked for three or more years.\n\nInclusion criteria for patients with cystic fibrosis include a defined genetic mutation (i.e., any of the known variants of the CFTR gene, such as delta F508 allele) or a cystic fibrosis phenotype and clinical features consistent with this disease. Children with cystic fibrosis over eight years of age may be included.\n\nPatients with established diagnoses of sarcoidosis; mycobacterial infections; TSC (definite or possible); cystic lung diseases including genetic diseases; lymphangioleiomyomatosis or diseases associated with lymphatic disorders; history of pneumothorax; pulmonary fibrosis; asthma; histiocytosis X and diabetes mellitus will be included in this protocol. Relatives of patients may also be seen under this protocol. Children with lymphangiomatosis who are two years of age or older may be included. Participants with asthma may be enrolled at Suburban Hospital.\n\nResearch volunteers in the pulmonary control group are defined as individuals with no pulmonary disease (e.g. rheumatoid arthritis without evidence of pulmonary disease). Research volunteers in the diabetes control group are defined as individuals with no history of diabetes, coronary artery disease, or pulmonary disease.\n\nPregnant and or nursing women can be included in accordance with Federal Regulations at Subpart B of 45 CFR 46. Subjects who are pregnant and or nursing will be excluded from procedures during their pregnancy that are greater than minimal risk, until they are no longer pregnant and\u002For nursing. Procedures that will not be completed while the subject is pregnant and\u002For nursing including: PFTs, Six Minute Walk Test, thoracentesis, bronchoscopy, and measurements with imaging modalities requiring contrast or with radiation exposure such as Chest x-ray, CT scan, MRI. Allowing subjects to be included in the study may glean important information about individuals with uncommon pulmonary disease during and post pregnancy.\n\nPatients with abnormalities in ADP-ribosyltransferases, ADP-ribosyl-acceptor hydrolases, and their substrates. Children who are two years of age or older may be studied if they have a known defect in ADP-ribosylation, or if they have a family member with a defect in ADP-ribosylation and may be affected.\n\nEXCLUSION CRITERIA:\n\nExclusion criteria for all participants include:\n\n1. age less than 18 or greater than 90 except for NIH patients with diseases \u002Fdisorders as described in this protocol (except cystic fibrosis, lymphangiomatosis or defects in ADP-ribosylation) who are 16 years of age or older, patients with cystic fibrosis who are over eight years of age, patients who are two years of age or older with lymphangiomatosis or a known defect in ADP-ribosylation, or who have a family member with a defect in ADP-ribosylation, or unless patient-specific IRB approval is obtained and;\n2. inability to obtain reliable pulmonary function testing. As clarification, healthy volunteers, relatives of patients (except as noted for an ADP-ribosylation defect), and asthmatic patients from Suburban Hospital will be excluded if less than 18 or greater than 90 years of age.\n\nExclusion criteria for participating in the bronchoscopy portion of the study are:\n\n1. presence of any contraindication for fiberoptic bronchoscopy, with lavage and\u002For bronchial brushing;\n2. advanced stage of a pulmonary or a systemic illness such that the risk is judged to be significant even in the absence of a specific contraindication to the procedure\n3. allergy to topical anesthetic (e.g., lidocaine)\n4. current or recent respiratory infection (within the last 4 weeks)\n5. pregnancy or lactation\n6. age less than 18 or greater than 65.",true,"2 Years","90 Years",{"count":51,"type":20},3500,"OBSERVATIONAL","This study is designed to evaluate the genetics involved in the development of lung disease by surveying genes involved in the process of breathing and examining the genes in lung cells of patients with lung disease.\n\nThe study will focus on defining the distribution of abnormal genes responsible for processes directly involved in different diseases affecting the lungs of patients and healthy volunteers.\n\nOptional CT Sub-study\n\nThe standard CT scan will be compared to the low dose radiation CT scan for the 150 subjects enrolled in the sub-study to assess the variation between the two techniques. Specifically, the quantitative computer aided detection of lung CT abnormalities from LAM can be compared to assess whether low radiation dose CT exams is an alternative to conventional CT to monitor disease\n\nstatus.\n\nThis optional sub-study will be offered to up to 100 adult subjects with lung disease and up to 50 children age 9 and older with CF. Children will not be enrolled in the optional CT sub-study unless they have had a standard CT scan for medical purposes to use in comparison. One additional low dose radiation CT scan of the chest may be done as part of this sub-study when these subjects have their next annual CT scan.",[55,56,57,58,27],"Cystic Fibrosis","Pulmonary Fibrosis","Tuberous Sclerosis","Asthma",[60,61,62,63,64,65,66,55,58],"Genetic Polymorphism","Nitric Oxide Synthesis","Alpha 1-Antitrypsin","Candidate Genes","Lung Pathology","Natural History","Lung Disease","RECRUITING","2026-06-13",{"date":70,"type":32},"2026-06-16",{"date":72,"type":32},"1996-09-13",{"name":74,"class":75},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",2,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100507695","phase-1-a-study-of-xtmab-16-in-patients-with-pulmonary-sarcoidosis-100507695","NCT05890729","A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis","A Seamless, Phase 1b\u002F2 Multiple Ascending Dose\u002FProof of Concept Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations","Inclusion Criteria:\n\n1. Participant between 18 to 80 years (inclusive) of age.\n2. Weighs between 45 kg and 160 kg (99 to 353 lbs) at Screening.\n3. Diagnosis of pulmonary sarcoidosis (at least 6 months before Screening) using the 2020 American Thoracic Society (ATS) Clinical Practice Guideline (Crouser et al, 2020), the European Respiratory Society (ERS) or the WASOG criteria including a compatible clinical and radiologic presentation with other causes of granulomatous disease ruled out (cutaneous and ocular involvement permitted).\n4. Modified Medical Research Conference (mMRC) Dyspnea Scale of ≥ 1.\n5. Receiving treatment of 7.5 to 25 mg\u002Fday of oral prednisone, or equivalent, during the screening period and, at the determination of the investigator, is capable of undergoing the protocol specific corticosteroid taper regimen.\n6. Receiving treatment with methotrexate, azathioprine, mycophenolate, leflunomide, chloroquine, or hydroxychloroquine for at least 3 months before Screening that has been at a stable dose for 4 weeks before Screening. All efforts should be made to maintain stable background therapy at the Screening dose through the intervention period at the Investigator's discretion.\n7. PART A only: Willing to refrain from consumption of grapefruit or grapefruit juice \\[pomelos, exotic citrus fruits, or grapefruit hybrids\\] from screening visit until after the final dose.\n8. Polymerase chain reaction (PCR) test or rapid antigen test negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening.\n9. Able to provide written informed consent.\n10. In the opinion of the Investigator, the participant is capable of understanding and complying with protocol requirements\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women or women who are planning to become pregnant during the study.\n2. PART A ONLY: Participants \\> 65 years of age. (This exclusion criterion is only applicable for EU).\n3. PART A ONLY: Known potentially significant fibrotic disease and\u002For active inflammation contained solely in the hilar region as shown by high-resolution computed tomography (HRCT), confirmed by a central reader. Participants with current active inflammation in the hilar region with concurrent inflammation outside the hilar region may be included.\n\n   A historical HRCT performed within 6 months of screening may be submitted for diagnostic confirmation by central review. If a subject's last HRCT was from \\> 6 months of screening, an HRCT should be performed during screening for diagnostic confirmation by central review.\n4. PART A ONLY: Any prior TNFα inhibitor therapy.\n5. Clinically significant extra-pulmonary sarcoidosis requiring systemic therapy as determined by the investigator.\n6. PART B ONLY: Any therapy with an anti-TNFα monoclonal antibody (e.g., infliximab, adalimumab, golimumab and their biosimilars) within 6 months.\n7. Baseline percent predicted forced vital capacity (FVC) of \\\u003C 50%.\n8. Prior treatment with rituximab or repository corticotropin injection within the previous 12 months.\n9. Clinically significant Central Nervous System (CNS) sarcoidosis requiring therapy, except history of isolated seventh cranial nerve palsy or evidence of demyelinating neurologic disease.\n10. Advanced congestive heart failure (New York Heart Association \\[NYHA\\] 3 or 4).\n11. Current disease presentation consistent with Lofgren's syndrome (i.e., presence of the triad of erythema nodosum, bilateral hilar lymphadenopathy on chest X-ray, and joint pain).\n12. Clinically significant pulmonary hypertension requiring treatment. Note: Clinically significant pulmonary hypertension requiring treatment would be defined as treatment with, i.e., prostacyclins, phosphodiesterase 5 inhibitors, and endothelin receptor antagonists.\n13. Known hypersensitivity to any component of the formulation of XTMAB-16.\n14. Live or messenger ribonucleic acid (mRNA) vaccination within 2 weeks before Day 1 or inoculation with a live or mRNA vaccine is planned during study participation.\n15. Evidence of active or latent TB by interferon-gamma release assay (IGRA) or invasive fungal infections at Screening.\n16. Known positive history of malignancy other than non-melanomatous skin cancer in the last 2 years, including in-situ carcinoma of the uterine cervix completely cured by radical surgery.\n17. Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, coronavirus disease (COVID-19), TB, or a known history of human immunodeficiency virus (HIV) infection at Screening.\n18. Women of childbearing potential who are sexually active with a non-sterilized male partner and are not willing to adhere to highly effective birth control measures from the time of signing the informed consent, throughout the duration of the study, and for 90 days after 5 half-lives have elapsed since the last dose of study drug.\n19. Male participants who are non-sterilized and sexually active with a female partner of childbearing potential and are not willing to use highly effective contraception from the time of signing the informed consent throughout the duration of the study, and for 90 days after 5 half-lives have elapsed since last dose of study drug.\n20. Clinically significant hepatic or renal disease, including uncontrolled diabetes at the discretion of the investigator.\n21. Any severe prior reaction to any type of biologics or human blood product such as albumin, IgG, etc.\n22. Concurrent emphysema.\n23. Known hypercalcemia due to non-sarcoidosis conditions such as untreated hyperparathyroidism, at the discretion of the investigator.\n24. Abnormal ECG: ventricular arrhythmias (non-sustained ventricular tachycardia (VT), multifocal or frequent premature ventricular contractions, bundle branch block, axis deviation, or abnormal Q waves). In the case of a QTcF (corrected QT interval by Fredericia) interval \\> 450 ms (men) or \\> 480 ms (women; participants with bundle branch block) or PR interval outside the range of 120 to 220 ms, the assessment may be repeated once for eligibility determination at Screening or Baseline.\n25. Donation or loss of 450 mL or more of his or her blood volume (including plasmapheresis) or transfusion of any blood product within 90 days prior to dosing.\n26. Known uncontrolled hypertension. Note: Uncontrolled hypertension is noted as blood pressure ≥ 160\u002F100 mmHg despite antihypertensive therapy within 3 months of randomization.\n27. Clinical signs and symptoms consistent with COVID-19, e.g., fever, dry cough, dyspnea, sore throat, fatigue, new smell or taste disorder or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening.\n28. In the opinion of the investigator, inability to tolerate corticosteroid taper.\n29. Concurrent systemic steroid use for non-sarcoidosis conditions.\n30. Concurrent known auto-immune disease requiring treatment.\n31. Participation in another clinical trial of an investigational agent within 3 months (small molecule) \u002F 6 months (biologics) or 5 half-lives (if known) of the agent, whichever is longer.\n32. Any condition that required hospitalization within the 3 months prior to Day 1 or is likely to require so during the study.\n33. Clinically significant abnormalities in the Screening physical exam, medical history, vital signs, ECG, or clinical laboratory tests that are not known to be due to concurrent sarcoidosis, and in the opinion of the Investigator and Medical Monitor should preclude the participant's participation in the clinical study.",{"count":85,"type":20},94,[23,24],"A phase 1b\u002F2 study of XTMAB-16 in patients with pulmonary sarcoidosis",[27],"2026-05-19",{"date":91,"type":32},"2026-05-20",{"date":93,"type":32},"2023-11-10",{"date":95,"type":20},"2029-05",{"name":38,"class":39},34,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100531847","phase-2-efficacy-and-safety-study-of-oatd-01-in-patients-with-active-pulmonary-sarcoidosis-100531847","NCT06205121","Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis","A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of a 12-week Administration of OATD-01, an Oral Inhibitor of Chitinase-1 (CHIT1), for the Treatment of Active Pulmonary Sarcoidosis (the KITE Study)","Inclusion Criteria:\n\n* Male and female subjects with active symptomatic pulmonary sarcoidosis, (definite diagnosis of active pulmonary sarcoidosis per ATS guidelines)\n* Treatment-naïve or previously treated (no recruitment cap)\n* Parenchymal pulmonary involvement on \\[18F\\]FDG PET\u002FCT\n\nExclusion Criteria:\n\n* Requirement for immediate start of standard of care therapy for pulmonary sarcoidosis\n* Active cardiac or neuro- sarcoidosis\n* History of\u002Factive Löfgren syndrome\n* Clinically significant lung disease other than sarcoidosis (e.g. tuberculosis, asthma, Chronic Obstructive Pulmonary Disease, interstitial lung disease, lung cancer) or any current inflammatory or immunological systemic disease other than sarcoidosis\n* Potentially effective systemic or inhaled pharmacological (including investigational) therapy for sarcoidosis (whether pulmonary or other disease), with the exception of any of the following:\n\n  1. corticosteroids received not later than 3 months prior to enrolment\n  2. immunosuppressants or anti-Tumor Necrosis Factor (TNF) agents (or other anti-inflammatory\u002Fanti-fibrotic treatment) received not later than 4 months prior to enrolment\n* Systemic treatment indication being an extrapulmonary location of sarcoidosis (e.g., neurological)\n* Heart conditions: QTcF interval prolongation, cardiac arrhythmia (other than non-sustained supraventricular arrhythmia), heart failure (New York Heart Association class III or IV) and\u002For known myocardial hypertrophy or Left Ventricle Ejection Fraction \\<50% in the cardiac MRI\n* Known neurosarcoidosis or small fiber neuropathy or medical conditions causing primary ataxia\n* Lab abnormalities: Abnormal bilirubin, transaminases, alkaline phosphatase (ALP), Creatinine clearance (CrCL) Hypokalemia hypocalcemia (\\<2.1 mmol\u002FL), marked fasting hyperglycemia at screening\n* Uncontrolled diabetes at Screening with plasma glucose exceeding 8.3 mmol\u002FL, or other contraindication to \\[18F\\]FDG administration and\u002For PET procedure (including body temperature \\>37°C and any metabolic disease affecting the energy metabolism of muscles) as described in the PET protocol\n* Known positivity for Human Immunodeficiency Virus (HIV 1\u002F2 antibodies), hepatitis B virus (HBV), or hepatitis C virus (HCV), or detected at screening\n* Severe, uncontrolled systemic disease (e.g., cardiovascular, pulmonary, thyroid, renal or metabolic disease) at Screening, or other condition, which in the opinion of the investigator, would compromise the safety of the subject or the subject's ability to participate in the study\n* Current smoker of \\>5 cigarettes or e-cigarettes per day or user of nicotine-releasing alternatives (patches, chewing gums etc)\n* Prohibited medications: Current treatment with drug with QT prolongation effect, thiazide diuretics, strong CYP3A4 inhibitors and\u002For inducers, P-glycoprotein and\u002For BCRP strong inhibitors, drugs that are sensitive substrates of OCT1, MATE1, MATE2K, OAT3 with a narrow therapeutic index, pirfenidone and nintedanib.",{"count":106,"type":20},96,[24],"This is a Phase 2, randomized, double-blind, placebo-controlled, adaptive, multicenter study to evaluate the efficacy, safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of OATD-01 in the treatment of subjects with active pulmonary sarcoidosis.",[27],[27,111,112],"Sarcoidosis","Chitinase","2025-12-05",{"date":115,"type":32},"2025-12-12",{"date":117,"type":32},"2024-03-21",{"date":119,"type":20},"2027-09",{"name":121,"class":39},"Molecure S.A.",28,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":152},"100581709","comparative-diagnostic-yield-of-endobronchial-cryo-biopsy-vs-forceps-biopsy-in-patients-with-suspected-sarcoidosis-100581709","NCT06853834","Comparative Diagnostic Yield of Endobronchial Cryo Biopsy vs Forceps Biopsy in Patients With Suspected Sarcoidosis","Prospective Randomized Controlled Study Comparing Diagnostic Yield of Endobronchial Cryo Biopsy vs Forceps Biopsy in Patients Undergoing Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for Suspected Sarcoidosis","CREBS","Inclusion Criteria:\n\nAll patients of suspected pulmonary sarcoidosis scheduled for routine EBUS-TBNA\n\nExclusion Criteria:\n\n1. Patient age less than 18 years\n2. Patients with co-morbid conditions like Diabetes mellitus, renal failure, chronic liver disease or any other chronic disease.\n3. Patients already on treatment with steroids or h\u002Fo steroids intake in last three months or on disease modifying and immunosuppressive drugs.\n4. Final Diagnosis other than sarcoidosis",{"count":132,"type":20},150,[134],"NA","Sarcoidosis is a multi-systemic granulomatous disease of unknown cause that is characterized by the formation of non-caseous epithelioid cell granulomas. Sarcoidosis involves the respiratory system in \\> 90% of cases, usually the hilar and mediastinal nodes, and, less frequently, the lung tissue. Airway involvement, as judged by clinical features, physiologic testing, imaging techniques, bronchoscopy, and airway mucosal biopsy, has been observed in nearly two-thirds of patients with sarcoidosis. Although sarcoidosis involving thoracic lymph nodes and pulmonary parenchyma is familiar to most clinicians, airway involvement is often overlooked. The frequency of airway involvement increases as the parenchymal disease progresses, and\\\\airway involvement is associated with increased morbidity, respiratory symptoms, and mortality. The initial airway abnormality is the inflammation manifested by mucosal edema, erythema, and the formation of granulomas. As the airway disease progresses, the mucosa may demonstrate granularity, nodularity, cobble stoning, and friability. Sarcoid granulomas tend to develop along the bronchovascular bundle or in the vicinity of the airways. Overall quality of the endobronchial biopsy (EBB) will depend on the method by which it is obtained and cryo-EBB will most likely to provide better tissue for the diagnosis in comparison to forceps biopsy which has smaller sample as well as crush artifacts. Therefore, it is hypothesized that cryo-EBB will be better than forceps EBB and combined together it will increase the overall diagnostic yield of the sarcoidosis when combined with lymph node sampling by endobronchial ultrasound guided trans-bronchial needle aspiration (EBUS-TBNA).\n\n1. Primary objective: To compare the diagnostic yield of cryo-EBB with forceps biopsy in patients undergoing routine EBUS-TBNA for suspected sarcoidosis.\n2. Secondary Objective: To evaluate the overall diagnostic yield of combined endobronchial biopsy and EBUS-TBNA in patients undergoing routine EBUS-TBNA for suspected sarcoidosis.\n\nThe relevance and the expected outcome of the proposed study\n\n1. The study will provide insight to obtain an endobronchial biopsy either with cryo probe or forceps\n2. The study will also provide information regarding overall increase in diagnostic yield if any when the endobronchial biopsies are combined with EBUS-TBNA.",[137,27],"Sarcoidosis Lung",[139,140,27,141],"Forceps Endobronchial Biopsy","Cryo-Endobronchial Biopsy","Diagnostic yield of endobronchial biopsy in sarcoidosis","2025-02-28",{"date":144,"type":32},"2025-03-03",{"date":146,"type":32},"2024-01-01",{"date":148,"type":20},"2025-04-30",{"name":150,"class":151},"Sanjay Gandhi Postgraduate Institute of Medical Sciences","OTHER_GOV",1]