[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Molecure S.A.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100531847","phase-2-efficacy-and-safety-study-of-oatd-01-in-patients-with-active-pulmonary-sarcoidosis-100531847",false,"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.","ALL","18 Years",{"count":19,"type":20},96,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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.",[26],"Pulmonary Sarcoidosis",[26,28,29],"Sarcoidosis","Chitinase","RECRUITING","2025-12-05",{"date":33,"type":34},"2025-12-12","ACTUAL",{"date":36,"type":34},"2024-03-21",{"date":38,"type":20},"2027-09",{"name":40,"class":41},"Molecure S.A.","INDUSTRY",28,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":64,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100497644","phase-1-first-in-human-phase-i-study-to-evaluate-safety-tolerability-and-antineoplastic-activity-of-oatd-02-in-patients-with-selected-advanced-andor-metastatic-solid-tumours-100497644","NCT05759923","First-in-human Phase I Study to Evaluate Safety, Tolerability and Antineoplastic Activity of OATD-02 in Patients with Selected Advanced And\u002For Metastatic Solid Tumours","An Open-label, Multicentre, Dose-escalation, First-in-human Phase I Study to Evaluate Safety, Tolerability and Antineoplastic Activity of OATD-02 in Patients with Selected Advanced And\u002For Metastatic Solid Tumours (colorectal Cancer, Ovarian Cancer, Pancreatic Cancer or Renal Cell Carcinoma)","Inclusion Criteria:\n\n1. Capable of understanding and complying with protocol requirements.\n2. Male or female patient aged ≥18 years at Screening.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Histologically or cytologically confirmed advanced and\u002For metastatic colorectal cancer, renal cell cancer, or pancreatic cancer or recurrent serous ovarian cancer (platinum-resistant\u002Fineligible to receive platinum-based chemotherapy), that either progressed or relapsed after all relevant standard of care cancer therapies (at least 1 line of systemic cancer therapy).\n5. Written informed consent given by the patient before the initiation of any study procedures.\n\nExclusion Criteria:\n\n1. Unable to take oral medications.\n2. Clinically active central nervous system metastases and\u002For carcinomatous meningitis.\n3. Major surgery within 30 days before the first IMP dose.\n4. Pregnant or breastfeeding women.\n5. Known allergy to excipients of the IMP.\n6. Severe, uncontrolled systemic disease which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to participate in the study.\n7. Participation in another clinical study within 4 weeks before the first IMP dose.",{"count":51,"type":20},40,[53],"PHASE1","The goal of this clinical trial is to learn if the OATD-02 administration (orally) in monotherapy is safe and has the pharmacodynamic potential to restore and enhance tumour responses to immunotherapy through increased arginine levels or intrinsic anti-tumour activity in participants with advanced metastatic colorectal cancer, ovarian cancer, renal cancer or pancreatic cancer.",[56,57,58,59,60,61,62,63],"Advanced Ovarian Carcinoma","Advanced Renal Cell Carcinoma","Advanced Pancreatic Carcinoma","Advanced Colorectal Carcinoma","Metastatic Pancreatic Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Renal Cell Carcinoma","Metastatic Ovarian Carcinoma",[65,66,67,68,69],"solid tumors","renal cancer","ovarian cancer","pancreatic cancer","colorectal cancer","2025-02-20",{"date":72,"type":34},"2025-02-24",{"date":74,"type":34},"2023-01-26",{"date":76,"type":20},"2025-12",{"name":40,"class":41},3,""]