[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Abivax S.A.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,73],{"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":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100551169","phase-2-efficacy-and-safety-of-obefazimod-in-subjects-with-moderately-to-severely-active-crohns-disease-100551169",false,"NCT06456593","Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease","A Phase 2b, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease","ENHANCE-CD","Inclusion Criteria:\n\n1. Male or female (at birth) 18 to 75 years old and able to understand, sign, and date the written voluntary informed consent at the visit prior to any protocol-specified procedures\n2. Able and willing to comply with study visits and procedures as per protocol.\n3. Confirmed and documented diagnosis of CD based on endoscopy and histology reports.\n4. Moderately to severely active CD as defined by 220 ≤ CDAI ≤ 450 and SES-CD ≥ 6 for ileo-colonic or colonic disease or SES-CD ≥ 4 for isolated ileal disease (per central reading).\n5. Documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids (CS), immunosuppressants (IS), biologic or biosimilar therapies, or janus kinase (JAK) (note: failure to only 5-aminosalicylic acid \\[5-ASA\\] is not accepted)\n6. Women of childbearing potential (WOCBP) and male subjects with WOCBP partner must agree to comply with contraception requirements as stated in section 4.5 (contraception) of this protocol.\n7. Subject should be affiliated to a health insurance policy whenever required by a participating country or state.\n8. Subject is able and willing to comply with usual public recommendations for sun protection.\n\nExclusion Criteria:\n\nSubjects who meet any of the following exclusion criteria will be excluded from the study:\n\n1. WOCBP subject who is pregnant or breast-feeding at screening, or intends to become pregnant during the study; or male subject with WOCBP partner who intends to be pregnant during the study.\n2. Current diagnosis of ulcerative colitis (UC) or indeterminate colitis\n3. CD without ileal and\u002For colonic involvement\n4. Untreated active external or perianal fistula or abscess. Stable fistula without abscess and with minimal or low drainage may be enrolled. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before screening colonoscopy or 8 weeks before screening colonoscopy for intra-abdominal abscesses, if no additional surgery is anticipated.\n5. Symptomatic bowel stricture and\u002For stenosis not passable in endoscopy\n6. Related to CD surgery:\n\n   1. Current stoma or ileoanal pouch\n   2. More than 2 missing complete segments of the following 5 segments: terminal ileum, right colon, transverse colon, left colon, and sigmoid and rectum\n   3. Combined previous small bowel resections \\> 100 cm\n   4. Surgical bowel resection within the past 3 months prior to baseline\n   5. Any other manifestation that might require surgery while enrolled in the study\n7. Related to CD treatments:\n\n   1. Subject who is currently treated with prohibited concomitant therapies for CD as described in the study protocol\n   2. Subject who has previously received natalizumab (or any other α4β1 integrin agonist)\n   3. Subject who has failed more than three advanced therapies for the treatment of CD, or two different mechanisms of action for advanced therapies of CD\n8. History of, or active, malignancy including nonmelanoma skin cancer (subjects with a 5-year disease-free survival are eligible)\n9. History of colonic cancer or colonic low grade or high grade dysplasia adenomatous polyps, and\u002For at the screening endoscopy, evidence of low grade or high grade dysplasia adenomatous polyps (fully removed or not)\n10. Subject with history of, or diagnosed with, the following during screening: primary sclerosing cholangitis, autoimmune hepatitis, or primary biliary cirrhosis\n11. Serious illness requiring hospitalization (not related to CD) within 4 weeks prior to screening\n12. Subject with the following infectious conditions:\n\n    1. Chronic or recurrent Grade 3 or Grade 4 infection within the last 2 months prior to screening or history of opportunistic infection while not on immunosuppressive therapy\n    2. Herpes zoster reactivation within the last 2 months prior to screening\n    3. Active infection at screening or any major episode of infection that required hospitalization or treatment with IV antibiotics within 1 month of screening or during screening (fungal infection of nail beds is allowed)\n    4. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) that required treatment per local medical practice or positive test for Clostridioides difficile (C. difficile) toxin at screening.\n    5. Subject with human immunodeficiency virus (HIV) infection\n    6. Acute or chronic hepatitis B infection at screening (positive for hepatitis B surface antigen \\[HbsAg\\] or negative for HbsAg and positive for anti-hepatitis B core antibody in conjunction with detectable hepatitis B virus \\[HBV\\] deoxyribonucleic acid \\[DNA\\], or detectable HBV DNA).\n    7. Acute or chronic hepatitis C virus (HCV) infection as defined by positive for hepatitis C antibody (subjects successfully treated and without recurrence ≥ 1 year with no detectable HCV RNA \\[assessed centrally\\] are eligible)\n    8. Active tuberculosis (TB) or untreated latent TB (For subjects with positive or intermediate QuantiFERON test)\n13. Subject with uncontrolled ischemic heart disease and\u002For a history of congestive heart failure\n14. Subject with a known family or personal history of congenital or acquired long QT syndrome, or subjects with a marked baseline prolongation of QT\u002F heart rate-corrected QT (QTc) interval\n15. Subject with a history of torsade de pointe (TdP)\n16. Acute or chronic clinically relevant pulmonary, hepatic, or renal functional abnormality, encephalopathy, neuropathy or unstable central nervous system pathology such as seizure disorder, or any other clinically significant medical problems.\n17. Subjects who received live vaccine within 3 months prior to screening and\u002For subject who is planning to receive such a vaccine during the study duration\n18. Acute or chronic pancreatitis\n19. Subject with the following hematological and biochemical laboratory parameters obtained during the screening period:\n\n    1. Hemoglobin ≤ 8.0 g\u002FdL1\n    2. Absolute neutrophil count \\\u003C 750\u002Fmm3\n    3. Platelets \\\u003C 100,000 \u002Fmm3\n    4. eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2\n    5. Total serum bilirubin \\> 1.5 x ULN (except if related to pre-existing and documented Gilbert syndrome)\n    6. Aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\> 2 x ULN\n20. Subject who does not meet the washout period requirements prior to the screening endoscopy as described in the prohibited medication section of the study protocol\n21. Use of any investigational or nonregistered product within 3 months or within 5 halflives preceding baseline, whichever is longer, and during the study.\n22. Subjects previously treated with obefazimod or with a known hypersensitivity to the active substance or to any of the excipients\n23. Illicit drug or alcohol abuse or dependence\n24. Subject who is committed to an institution by virtue of an order issued either by the judicial or the administrative authorities\n25. Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol","ALL","18 Years","75 Years",{"count":21,"type":22},212,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study has 3 treatment phases, a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase.\n\nThe objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and\u002For advanced therapies.\n\nThe primary objective for the 48-Week Extension Phase is to evaluate the safety and tolerability of obefazimod compared with placebo in subjects who are enrolled in the Extension Phase.",[28],"Moderately to Severely Active Crohn Disease",[30],"Crohn Disease","RECRUITING","2026-04-22",{"date":34,"type":35},"2026-04-27","ACTUAL",{"date":37,"type":35},"2024-10-30",{"date":39,"type":22},"2028-04",{"name":41,"class":42},"Abivax S.A.","INDUSTRY",149,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100627834","phase-1-study-to-evaluate-pharmacokinetics-relative-bioavailability-palatability-of-obefazimod-minitablet-formulation-100627834","NCT07453784","Study to Evaluate Pharmacokinetics, Relative Bioavailability, Palatability of Obefazimod Minitablet Formulation","Two-Part, Open-Label Study to Evaluate Single Dose Pharmacokinetics of an Obefazimod Minitablet Formulation, Estimate the Relative Bioavailability of the Minitablet Formulation and to Evaluate Minitablet Palatability in Healthy Participants","Inclusion Criteria:\n\n* Aged 18 to 55 years inclusive at the time of signing informed consent\n* Must agree to adhere to the contraception requirements.\n* Healthy male or non-pregnant, non-lactating female participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG and laboratory safety tests without any clinically significant abnormalities\n* Body mass index (BMI) of 18.0 to 32.0 kg\u002Fm2 as measured at screening\n* Weight ≥50 kg at screening Inclusion criteria.\n\nExclusion Criteria:\n\n* Presence or history of clinically significant allergy requiring treatment, as judged by the investigator.\n* History of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator\n* Participants with a history of cholecystectomy or gall stones\n* Participants with chronic or recurrent infection\n* Participants who have tested positive for tuberculosis\n* Participants with a history of shingles within the last two months\n* History of opportunistic infection while not on immunosuppressive therapy\n* Part 2 only: Participant has a medical condition that may adversely affect taste or smell activity including but not limited to mouth ulcers, significant gum disease, and respiratory and\u002For sinus infection or cold\n* Part 2 only: Participant does not agree to the consumption of, or has any known allergies to any of the food vehicles used in this study (applesauce, chocolate pudding, yogurt)\n* Participants who have received any IMP (Investigational Medicinal Product) in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer\n* Participants who have previously been administered IMP in this study\n* Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood\n* Participants who are taking, or have taken, any prescribed or over-the-counter drug, hormone replacement therapy (HRT) or herbal remedies (other than up to 4 g of paracetamol per day and hormonal contraception) in the 14 days or 5 elimination half-lives, whichever is longer, before first IMP administration (see Section 11.4). Exceptions may apply, as determined by the investigator\n* Having any vaccination or planned vaccination within 28 days before Day 1. Participants who received live vaccine within 3 months prior to screening and\u002For who are planning to receive such a vaccine during the study duration.\n* History of any drug or alcohol abuse in the past 2 years\n* Regular alcohol consumption in males \\>21 units per week and in females \\>14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)\n* Current smokers and those who have smoked within the last 12 months\n* Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months\n* Confirmed positive drugs of abuse test result at screening or admission",true,"55 Years",{"count":54,"type":22},44,[56],"PHASE1","The sponsor is developing a pediatric minitablet formulation as part of the overall pharmaceutical development strategy. In vitro dissolution and physiological-based bio-pharmaceutics modelling and simulation have been used to guide the development of the mini-tablet formulation to match the PK exposure of the adult capsule formulation. The study aims to investigate the relative bioavailability of the 50mg minitablet compared to the adult obefazimod 50 mg capsule in adult healthy volunteers.",[59],"Healthy",[61,62,63],"Healthy participants","obefazimod","minitablet","2026-03-31",{"date":66,"type":35},"2026-04-06",{"date":68,"type":35},"2026-03-03",{"date":70,"type":22},"2026-10",{"name":41,"class":42},1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100354639","phase-1-abx196-in-combination-with-nivolumab-in-patients-with-hepatocellular-carcinoma-100354639","NCT03897543","ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma","A Phase 1-2 Study of ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Men or women, Age ≥18 years\n* Patients with ECOG performance status 0 or 1\n* Patients with histologically confirmed diagnosis of HCC not amenable to curative surgery or local therapy\n* Patients with documented objective radiographic progression during or after local therapy or after treatment with sorafenib or lenvatinib or intolerance to or refusal to receive either agent\n* Patients with at least one prior systemic therapy for HCC\n* Patients eligible to be treated with nivolumab\n* Patients with measurable disease based on RECIST v1.1\n* Patients with Child-Pugh class A liver score within 7 days of first study dose\n* Patients with no history of hepatic encephalopathy\n* Patients with no prior or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control (patients with ascites only on radiographic imaging are eligible)\n* Patients with HBV infection must have received antiviral therapy for at least 12 weeks and HBV viral load must be documented to be \\\u003C100 IU\u002FmL within 7 days of first study dose\n* Patients with no active co-infection with HBV and HCV or HBV and HDV\n* Patients with no active drug or alcohol abuse\n\nExclusion Criteria:\n\n* Patients with tyrosine kinase inhibitor treatment within 2 weeks of first study dose\n* Patients with esophageal or gastric variceal bleeding within the past 6 months\n* Patients with portal vein invasion at the main portal (Vp4) or the inferior vena cava or cardiac involvement of HCC based on imaging\n* Patients with previous solid organ or hematologic transplantation\n* Patients with active autoimmune disease requiring systemic treatment in the past 2 years\n* Patients with diagnosis of immunodeficiency or receiving systemic steroid therapy or other immunosuppressive therapy within 7 days before first study dose\n* Patients with previous locoregional therapy or major surgery to the liver within 6 weeks before first study dose\n* Patients with minor surgery to liver or another site within 1 week before first study dose",{"count":81,"type":22},48,[56,25],"Open-label, uncontrolled, phase 1-2 study to evaluate the safety, tolerability, pharmacodynamic effects, and preliminary efficacy of ABX196 administered in combination with nivolumab in patients with hepatocellular carcinoma",[85],"Carcinoma, Hepatocellular",[87,88,89],"HCC","Nivolumab","ABX196","2021-03-25",{"date":92,"type":35},"2021-03-26",{"date":94,"type":35},"2019-08-30",{"date":96,"type":22},"2023-06-30",{"name":41,"class":42},2,""]