[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100308126":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":42,"centralContacts":42,"locations":42,"responsibleParty":47,"collaborators":42,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":42,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":42,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":42,"overallStatus":70,"whyStopped":71,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":78,"leadSponsor":80,"locationsCount":42},{"fullName":5,"class":6},"Tiziana Life Sciences LTD","INDUSTRY",[8,15,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","PLACEBO_COMPARATOR","Group A will receive placebo solution for 30 consecutive days",[13,14],"Other: placebo","Drug: Omeprazole 20mg",{"label":16,"type":17,"description":18,"interventionNames":19},"Group B","EXPERIMENTAL","Group B will receive 0.5 mg Foralumab Solution daily for 30 consecutive days",[20,14],"Drug: Foralumab",{"label":22,"type":17,"description":23,"interventionNames":24},"Group C","Group B will receive 2.5 mg Foralumab Solution daily for 30 consecutive days",[20,14],{"label":26,"type":17,"description":27,"interventionNames":28},"Group D","Group B will receive 5.0 mg Foralumab Solution daily for 30 consecutive days",[20,14],[30,37,43],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Foralumab","Anti CD3 mAb",[16,22,26],[36],"Anti CD3",{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"OTHER","placebo","Placebo oral solution",[9],null,{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"Omeprazole 20mg","Omeprazole is a proton pump inhibitor used to neutralize stomach PH",[9,16,22,26],{"type":48,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100308126","phase-2-assessment-of-the-safety-of-foralumab-an-oral-anti-cd3-antibody-in-patients-with-nash-and-t2dm-100308126",false,"NCT03291249","Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With NASH and T2DM","A Randomized, Placebo-controlled ,Double-blind, Phase IIa Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Provision of written informed consent\n* Diagnosis of T2DM\n* HbA1c \\\u003C 9.0 while on standard of care\n* Historical histology-based confirmation of NASH within 12 months prior to screening OR\n\nDiagnosis of NAFLD based on all the following:\n\n* Presentation of at least one other parameter of the metabolic syndrome from the following list of three:\n\n  (i) hypertension \\[≥130\u002F85 mmHg or regularly taking an antihypertensive\\], (ii) dyslipidemia with high serum triglycerides \\[≥150 mg\u002FdL or regularly taking medicines to lower high triglyceride levels\\] or low serum HDL \\[\\\u003C50 mg\u002FdL for women and \\\u003C40 mg\u002FdL for men\\], (iii) obesity (BMI \\> 30 kg\u002Fm2) or central obesity \\[waistline measurement ≥ 89 cm for women and ≥ 102 cm for men\\])\n* ALT \\> 40 IU\n* Fat fraction \\>10% in MRI performed during screening or up to 3 months prior to screening.\n* Agree to the use of effective contraceptive measures, as defined in the protocol, if either male or female with child-bearing potential.\n\nExclusion criteria:\n\n* Subject with cirrhosis per biopsy (fibrosis staging score \\>= 4) or Fibroscan® \\>14 kPa within 12 months of screening.\n* Presence of vascular liver disease\n* Any history or evidence of decompensated liver disease such as recurrent variceal bleeding, refractory ascites or hepatic encephalopathy\n* Known history of chronic alcoholic liver disease, chronic hepatitis B or C infection, drug-induced liver injury (DILI), hemochromatosis, Wilson's disease, 1-antitrypsin deficiency, primary biliary cirrhosis or secondary sclerosing cholangitis, autoimmune hepatitis\n* Known HIV antibody-positive\n* History of liver transplantation\n* BMI \\\u003C25kg\u002Fm2\n* Clinically significant alcohol use\n* Score of ≥ 2 on the CAGE questionnaire, OR\n* Any subject with current significant alcohol consumption or a history of significant alcohol consumption for a period of more than 3 consecutive months any time within 1 year prior to screening, as determined by medical history (medical chart review and\u002For interview). Significant alcohol consumption is defined as: females: \\>20 g\u002Fday; males: \\>30 g\u002Fday, with a standard drink in the US averaging 14 g alcohol.\n* Type 1 diabetes\n* Bariatric surgery within the last 5 years\n* Weight loss or gain of ≥5 kg in the past 6 months or \\>10% change in bodyweight in the past 12 months\n* Inadequate vascular access on physical examination\n* Lactating\u002Fbreastfeeding\u002Fpregnant at screening\n* On an elemental diet or parenteral nutrition\n* Concurrent conditions\n* Inflammatory bowel disease\n* Unstable angina, myocardial infarction, transient ischemic events, or stroke within 24 weeks of screening\n* Ongoing infectious disease, excluding recurrent urinary tract infection treated with long-term antibiotic prophylaxis\n* Any type of immune-mediated and\u002For malignant disease\n* Any other concurrent condition which, in the opinion of the investigator, could impact adversely on the participating subject or on the interpretation of the study data\n* Concurrent medications including:\n* Amiodarone taken within 30 days of Day 1 (MBT contraindication)\n* Beta-blockers: must be on a stable dose for at least 30 days prior to Day 1 (MBT contraindication)\n* Statins: must be on a stable dose for at least 30 days prior to Day 1 (MBT contraindication)\n* The following medications taken every day for more than 1 week over the last three months: S-adenosyl methionine (SAM-e), betaine, milk thistle and probiotic supplements (other than yoghurt) with the exception of vitamin E or gemfibrozil, which are allowed\n\n  \\*\\* If \\>= 400 IU vitamin E on a regular basis or gemfibrozil, at any dose, are used, the dose must be stable for more than 3 months;\n* immunomodulatory agents including In the last 4 weeks\n\n  * oral or parenteral antibiotics\n  * daily treatment with non-steroidal anti-inflammatory drugs (e.g., aspirin (\\>100 mg\u002Fday), ibuprofen, naproxen, imeloxicam, celecoxib)\n\nIn the last 3 months\n\n* systemic steroids\n* daily treatment with non-steroidal anti-inflammatory drugs (e.g., aspirin (\\>100mg\u002Fday), ibuprofen, naproxen, meloxicam, celecoxib) over 4 or more weeks in the last 3 months\n* variable dose of antilipidemic agents (HMG Co-A reductase inhibitors - \"statins\"). Subjects on stable dose of statins are eligible if missed no more than one week of dosing over the last 3 months\n\nIn the last 12 months\n\no azathioprine, 6-mercaptopurine, methotrexate, cyclosporin, anti-TNF alpha therapies (infliximab, adalimumab, etanercept) or anti-integrin therapies\n\n* Any of the following laboratory abnormalities:\n* Neutrophil count ≤1.0 x 109\u002FL\n* Platelets \\\u003C100 x 109\u002FL\n* Hemoglobin \\\u003C10g\u002FdL\n* Albumin \\\u003C3.5g\n* International Normalized Ratio (INR) \\>1.5\n* Total bilirubin \\>1.5 x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)\n* Either creatinine clearance ≤60mL\u002Fminute, calculated by Cockroft Gault, or creatinine \\>1.5x upper limit of reference range\n* Regular use of marijuana or marijuana-related products, or use of cocaine, or street drugs, as determined by medical history (medical chart review and\u002For interview).\n* Subjects with symptoms of significant mental illness, inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to provide informed consent.\n* Hypersensitivity to methacetin and\u002For its metabolites (i.e., paracetamol, acetaminophen)","ALL","18 Years","120 Years",{"count":60,"type":61},0,"ACTUAL","INTERVENTIONAL",[64],"PHASE2","This is a randomized, placebo-controlled, four-arm, double-blind study. Subjects will be randomized (1:1:1:1) to receive either a daily oral placebo solution or a daily oral dose of 0.5 mg, 2.5 mg or 5.0 mg Foralumab Solution for 30 consecutive days. Subjects will record adverse events and daily administration of study medication in a subject diary. This will serve as a measure of compliance and record of safety and tolerability. Subjects will be followed up for 30 days following completion of treatment.\n\nStudy visits performed on Days 14, 30 and 60 of the study, will monitor metabolic parameters (body mass index \\[BMI\\] and waist circumference), serum lipid profiles, immunological markers (c-reactive protein \\[CRP\\] and an array of cytokines), hepatic enzymes and functions (13C-methacetin breath test \\[MBT\\]) and liver steatosis\u002Ffibrosis, which will be compared to baseline levels (Day 1).\n\nThe safety and tolerability of the treatment regimen will be determined by monitoring vital signs, laboratory values, adverse events and physical findings throughout the study. In addition, its efficacy will be established upon either reduced Day 30 serum alanine aminotransferase (ALT) levels, reduced hemoglobin A1c (HbA1c) or improved homeostasis model assessment (HOMA) or HOMA of insulin resistance (HOMA-IR) scores as compared to baseline (Day 1). In addition, to assess the efficacy of the tested Foralumab Solution regimen in improving overall subject status, a battery of exploratory metabolic, immunologic and hepatic markers will be evaluated on Days 30 and 60.",[67,68,69],"NASH - Nonalcoholic Steatohepatitis","NAFLD","T2DM (Type 2 Diabetes Mellitus)","WITHDRAWN","Due to MOH request.","2019-09-10",{"date":74,"type":61},"2019-09-12",{"date":76,"type":77},"2017-12-01","ESTIMATED",{"date":79,"type":77},"2019-06-01",{"name":5,"class":6}]