[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dr. Falk Pharma GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100561906","phase-3-once-daily-versus-twice-daily-budesonide-orodispersible-tablets-for-induction-of-remission-in-eoe-100561906",false,"NCT06596252","Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE","Double-blind, Randomized, Non-inferiority Phase III Trial on the Efficacy and Tolerability of 2 mg Once Daily vs. 1 mg Twice Daily Budesonide Orodispersible Tablets in Adults With Eosinophilic Esophagitis","EOS-4","Inclusion Criteria:\n\n* Signed informed consent,\n* Male or female patients, 18 to 75 years of age,\n* Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria\n* Active symptomatic and histological EoE\n* Negative pregnancy test in females of childbearing potential at baseline visit.\n\nExclusion Criteria:\n\n* Clinical and endoscopic signs of gastroesophageal reflux disease (GERD),\n* Achalasia, scleroderma esophagus, or systemic sclerosis,\n* Other clinically evident causes than EoE for esophageal eosinophilia,\n* Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection \\[candida esophagitis\\]),\n* Any relevant systemic disease (e.g., AIDS, active tuberculosis, hepatitis B or C),\n* If careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection,\n* Liver cirrhosis or portal hypertension,\n* History of cancer in the last five years,\n* History of esophageal surgery at any time or of esophageal dilation procedures within the last 4 weeks prior to screening visit, or need for an immediate endoscopic intervention due to a stricture\n* Upper gastrointestinal bleeding within 8 weeks prior to baseline visit,\n* Existing or intended pregnancy or breast-feeding.","ALL","18 Years","75 Years",{"count":21,"type":22},308,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.",[28],"Eosinophilic Esophagitis","RECRUITING","2026-04-22",{"date":32,"type":33},"2026-04-27","ACTUAL",{"date":35,"type":33},"2021-05-21",{"date":37,"type":22},"2027-03",{"name":39,"class":40},"Dr. Falk Pharma GmbH","INDUSTRY",26,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100615879","phase-2-evaluating-the-efficacy-and-tolerability-of-zed1227-in-subjects-with-non-responsive-celiac-disease-100615879","NCT07298343","Evaluating the Efficacy and Tolerability of ZED1227 in Subjects With Non-responsive Celiac Disease","A Phase II, Double-blind, Randomised, Placebo-controlled Trial to Evaluate the Efficacy and Tolerability of ZED1227 in Celiac Disease Subjects Experiencing Symptoms Despite Gluten-free Diet","CEC-013\u002FCEL","Inclusion Criteria:\n\n* Signed informed consent\n* Men or women between 18 and 80 years of age, inclusively\n* Documented initial biopsy-proven diagnosis of celiac disease or, in case of missing histological documentation, TG2-IgA \\> 10 x upper limit of normal (ULN) at diagnosis at least 12 months prior to V0\n* Adherence to a gluten-free diet (GFD) for at least 12 months prior to V0\n* Human leukocyte antigen DQ (HLA-DQ) typing compatible with celiac disease\n\nExclusion Criteria:\n\n* Presence of hypo- or hyperthyroidism. A patient with a well-controlled thyroid disorder during the previous 3 months can be included\n* Patients diagnosed to have confirmed refractory celiac disease type I (RCDI) or II (RCDII), with the exception that patients with a diagnosis of RCDI can be considered for inclusion if they do not have clear signs of T cell monoclonality or atypical T cells (e.g., as revealed by CD3\u002FCD8 immunohistochemistry) and if they do not present with very severe symptoms and\u002For parameters of significant malabsorption and if they have not received prior treatment with immunosuppressants such as budesonide or azathioprine,\n* Severe complications of celiac disease\n* Concomitant diseases of the intestinal tract in addition to celiac disease, such as Crohn's disease, ulcerative colitis, other forms of inflammatory bowel disease, severe irritable bowel syndrome, microscopic colitis, small intestinal bacterial overgrowth (SIBO), exocrine pancreatic insufficiency; any other active diseases of the intestinal tract (e.g., active, untreated peptic ulcer, esophagitis, gastroesophageal reflux disease) that might, in the investigator's opinion, interfere with assessment of symptoms of abdominal pain, diarrhoea, or other components of celiac disease\n* History or presence of dermatitis herpetiformis","80 Years",{"count":52,"type":22},356,[54],"PHASE2","A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet",[57],"Celiac Disease",[57,59],"non-responsive Celiac Disease","2026-04-01",{"date":62,"type":33},"2026-04-02",{"date":64,"type":33},"2024-06-10",{"date":66,"type":22},"2027-08",{"name":39,"class":40},1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":4},"100584209","phase-3-study-with-norucholic-acid-tablets-in-patients-with-primary-sclerosing-cholangitis-psc-100584209","NCT06886360","Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)","An Open-label Study of Patients with Primary Sclerosing Cholangitis (PSC) Treated with Norucholic Acid Tablets","Inclusion criteria:\n\n1. Signed informed consent.\n2. Males or females ≥ 18 years.\n3. Patient has previously been diagnosed with PSC, has participated in the previous NUC 5\u002FPSC trial and has completed the DBE phase with Visit 22, or has prematurely terminated the DBE phase before this trial has been started, or has prematurely terminated the DBE phase after this trial has been started, under the condition that the premature termination was due to lack of efficacy\\*. (\\*Lack of efficacy as defined in the NUC-5\u002FPSC trial.)\n\nExclusion Criteria:\n\n1. History or presence of chronic alcoholic consumption (daily consumption \\> 30 g in men, \\> 20 g in women).\n2. Patients who discontinued study participation in NUC-5\u002FPSC due to an AE possibly caused by the study drug.\n3. Liver Cirrhosis or any cirrhosis-related symptoms which in the opinion of the investigator may affect the patient's safety.\n4. History of liver transplantation or patient listed for transplantation.",{"count":77,"type":22},120,[25],"Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis",[81],"Primary Sclerosing Cholangitis","NOT_YET_RECRUITING","2025-03-19",{"date":85,"type":33},"2025-03-20",{"date":87,"type":22},"2025-03",{"date":89,"type":22},"2027-09",{"name":39,"class":40},""]