[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Eisai Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":144},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,68,92,117],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100632540","phase-2-a-study-of-e6742-in-participants-with-systemic-lupus-erythematosus-100632540",false,"NCT07515014","A Study of E6742 in Participants With Systemic Lupus Erythematosus","A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Response Study to Evaluate the Efficacy and Safety of E6742 in Subjects With Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Male or female adult, age \\>=18 years (the minimum age may be different from 18 years in certain countries based on regional requirements) and \\\u003C=75 years at the time of informed consent\n2. Diagnosed with SLE at least 6 months before the informed consent AND fulfill the 2019 EULAR\u002FACR classification criteria at Screening based on medical history\n3. At least BILAG-2004 category A in \\>=1 organ system or BILAG-2004 category B in \\>=2 organ systems at screening\n4. SLEDAI-2K score \\>=6 points at Screening AND Clinical SLEDAI-2K score \\>=4 points at Baseline\n5. Receiving at least one of the following treatments for SLE (if more than 1 treatment is used, all medications must be within the dosage defined in the protocol):\n\n   1. OCS (\\\u003C=30 mg\u002Fday, prednisone or equivalent): The dosing regimen should be stable for at least 4 weeks before the first dose of study drug.\n   2. Oral hydroxychloroquine (\\\u003C=400 mg\u002Fday), quinacrine (\\\u003C=200 mg\u002Fday): These medications should have been initiated or discontinued at least 12 weeks before the first dose of study drug, and the dosing regimen should remain stable for at least 8 weeks before the first dose.\n   3. Immunosuppressants: The following medications should have been initiated or discontinued at least 12 weeks before the first dose of study drug, and the dosing regimen should remain stable for at least 8 weeks before the first dose\n\n      * Mycophenolate mofetil (\\\u003C=3 g\u002Fday)\n      * Mycophenolate sodium (\\\u003C=2160 mg\u002Fday)\n      * Azathioprine (\\\u003C=200 mg\u002Fday)\n      * 6-mercaptopurine (\\\u003C=100 mg\u002Fday)\n      * Methotrexate (oral\u002Fsubcutaneous\u002Fintramuscular) (\\\u003C=25 mg\u002Fweek)\n6. Willing and able to provide written informed consent and comply with all aspects of the protocol\n\nExclusion Criteria\n\n1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \\[ß-hCG\\] or human chorionic gonadotropin \\[hCG\\] test). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.\n2. Females of childbearing potential who:\n\n   1. Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:\n\n      * Total abstinence (if it is their preferred and usual lifestyle)\n      * An intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)\n      * A contraceptive implant\n      * Combined estrogen and progestogen-containing hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception associated with inhibition of ovulation, such as desogestrel (oral, injectable). Participants using hormonal contraceptives must be on a stable dose of the same contraceptive product for at least 28 days before dosing, throughout the study, and for at least 28 days following study drug discontinuation.\n      * Have a vasectomized partner with confirmed azoospermia\n   2. Do not agree to use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation.\n   3. Participants on an oral contraceptive must use an additional barrier method throughout the study and for 28 days after study drug discontinuation.\n3. Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners meet the exclusion criteria above (ie, the female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation). No sperm donation is allowed during the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation.\n4. Drug-induced lupus erythematosus\n5. Active or unstable neuropsychiatric lupus (including but not limited to any condition defined by BILAG category A in neuropsychiatric organ system)\n6. Systemic autoimmune diseases other than SLE (eg, rheumatoid arthritis, Crohn's disease, systemic sclerosis \\[SSc\\], multiple sclerosis, polymyositis\u002F dermatomyositis \\[PM\u002FDM\\]) that may affect the assessment of SLE pathology at Screening. The participants with the following diseases may be included in the study\n\n   * Sjögren's syndrome secondary to SLE\n   * Antiphospholipid antibody syndrome (APS) secondary to SLE\n   * Mixed Connective Tissue Disease (MCTD) not meeting diagnostic criteria for PM and SSc\n7. Any clinically significant symptom or organ impairment found by chest X-ray, ophthalmic examination, vital signs, or ECG finding at Screening or Baseline, laboratory test at Screening that in the opinion of the investigator could affect the participants safety or interfere with the study assessments.\n8. Laboratory test results meeting any of the following criteria at Screening:\n\n   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3× upper limit of normal (ULN)\n   * Absolute neutrophil count (ANC) \\\u003C1,000 \u002FmcL\n   * Platelet count \\\u003C50,000 \u002FmcL\n   * Hemoglobin \\\u003C8.0 g\u002FdL\n9. Renal impairment falling under any of the following criteria at Screening:\n\n   * Urine protein\u002Fcreatinine ratio \\>2.0 g\u002FgCr\n   * Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \\[MDRD\\]) \\\u003C40 mL\u002Fmin\u002F1.73 m\\^2\n10. Received vaccination within 2 weeks before the first dose of study drug (4 weeks before in case of live\u002F live attenuated vaccines)\n11. Currently or previously receiving gene therapy for SLE (eg, CAR-T cell therapy)\n12. Currently enrolled in another clinical study or used any investigational drug or device (including E6742) within 28 days (or 5× the half-life, whichever is longer) before obtaining informed consent\n13. Any history of the following clinically significant infections:\n\n    * Infections requiring hospitalization or intravenous antibiotics, or administration of antiviral drugs, within 4 weeks before the first dose of study drug\n    * Active tuberculosis\n14. Any findings indicating a history of tuberculosis on chest X-ray at Screening\n15. Positive or repeated hold (indeterminate or intermediate) in tuberculosis test (Interferon-γ release assays) at Screening\n16. A prolonged QTc interval calculated using Fridericia's formula (QTcF) greater than 450 millisecond (ms) according to central reading at Screening. If the QTcF machine read is greater than 440 ms on the first single 12-lead ECG, 2 additional 12-lead ECGs will be performed 1 minute apart and the mean of the 3 QTcF values will be used for evaluation.\n17. A prolonged QTcF interval (mean QTcF \\>450 ms) as demonstrated by triplicated ECGs at Baseline. Has any risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolonged the QTcF interval (excluding hydroxychloroquine).\n18. Hypersensitivity to the study drug, drug product chemical derivate or any of the excipients at Screening\n19. Any history of or concomitant medical condition that in the opinion of the investigators would compromise the participants ability to safely complete the study\n20. Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the study. Planned surgery which requires only local anesthesia and that can be undertaken as a day case without inpatient stay postoperatively need not result in exclusion if in the opinion of the investigator this operation does not interfere with study procedures and participant safety\n21. Positive on test at Screening for human immunodeficiency virus (HIV)\n22. Positive on test at Screening for hepatitis B virus (HBV) with a detectable (eg, hepatitis B virus surface \\[HBs\\] antigen reactive, HBs antibody, hepatitis B virus core \\[HBc\\] antibody, HBV deoxyribose nucleic acid (DNA)) or hepatitis C virus (HCV) with a detectable (eg, HCV ribonucleic acid (RNA) \\[qualitative\\], HCV antibody) viral load\n23. Psychotic disorders or unstable recurrent affective disorders evident by use of antipsychotics within 2 years before Screening\n24. History of drug or alcohol dependency or abuse within 2 years before Screening\n25. History or concurrent of malignancy, lymphoma, leukemia, or lymphoproliferative disease (except for basal cell skin cancer, squamous cell skin cancer, and cervical cancer that have been cured by surgical operation)\n26. Assessed to be inappropriate for clinical study by investigators","ALL","18 Years","75 Years",{"count":20,"type":21},256,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The main purpose of the study is to demonstrate the efficacy based on dose response of E6742 compared with placebo as defined by the proportion of participants achieving a response using the British Isles Lupus Assessment Group (BILAG) based Composite Lupus Assessment (BICLA) with a low dose of oral corticosteroids (OCS) (prednisone or equivalent) at Week 24 in participants with systemic lupus erythematosus (SLE).",[27],"Systemic Lupus Erythematosus","RECRUITING","2026-07-01",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":32},"2026-03-31",{"date":36,"type":21},"2029-03-01",{"name":38,"class":39},"Eisai Co., Ltd.","INDUSTRY",41,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100566607","a-study-to-evaluate-the-safety-of-fycompa-injection-in-participants-with-partial-onset-seizures-or-primary-generalized-tonic--clonic-seizures-100566607","NCT06657378","A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized Tonic- Clonic Seizures","A Multicenter, Postmarketing Observational (Noninterventional) Study to Evaluate the Safety of Fycompa for Injection in Patients With Partial-Onset Seizures (Including Secondarily Generalized Seizures) (Age 4 Years or Older) or Primary Generalized Tonic- Clonic Seizures (Age 12 Years or Older)","Inclusion Criteria:\n\n* Participants with epilepsy who received the Fycompa for injection for the first time will be included.\n\nExclusion Criteria:\n\n* The exclusion criteria will not be specified in particular because this survey will be conducted in daily clinical practice.","4 Years",{"count":50,"type":21},110,"OBSERVATIONAL","The purpose of this study is to determine the safety of Fycompa for injection after administration in participants with epilepsy (partial-onset seizures \\[including secondarily generalized seizures\\]) (age 4 years or older) or primary generalized tonic-clonic seizures (age 12 years or older).",[54,55],"Partial-Onset Seizures","Primary Generalized Tonic-clonic Seizures",[57,58,59],"Seizures","Secondarily Generalized Seizures","Fycompa","2026-06-30",{"date":29,"type":32},{"date":63,"type":32},"2024-11-18",{"date":65,"type":21},"2028-06-15",{"name":38,"class":39},1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":67},"100577085","a-post-marketing-observational-study-of-tasfygo-in-participants-with-unresectable-biliary-tract-cancer-with-fibroblast-growth-factor-receptor-2-fgfr2-fusion-gene-positivity-who-progressed-after-chemotherapy-100577085","NCT06793709","A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene Positivity Who Progressed After Chemotherapy","Post-marketing Observational Study of Tasfygo Tablet 35 mg to Evaluate the Safety of Tasfygo in Patients With Unresectable Biliary Tract Cancer With FGFR2 Fusion Gene Positivity Who Progressed After Chemotherapy","Inclusion Criteria:\n\n1\\. Participants with unresectable biliary tract cancer with FGFR2 fusion gene positivity who are naïve to Tasfygo tablet and progressed after chemotherapy.\n\nExclusion Criteria:\n\nNot applicable.",{"count":76,"type":21},60,"The primary purpose of this study is to investigate the safety of Tasfygo.",[79],"Biliary Tract Cancer",[81,82,83],"Tasfygo","FGFR2 fusion","Cancer","2026-02-25",{"date":86,"type":32},"2026-02-27",{"date":88,"type":32},"2025-07-10",{"date":90,"type":21},"2032-11-20",{"name":38,"class":39},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100540886","a-post-marketing-study-in-participants-with-early-alzheimers-disease-treated-with-lecanemab-100540886","NCT06322667","A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab","A Multicenter, Postmarketing Observational Study to Evaluate Safety Regarding Amyloid-Related Imaging Abnormalities and Their Management in Patients With Early Alzheimer's Disease and Treated With Lecanemab","Inclusion Criteria:\n\n* All participants who are treated with lecanemab in routine clinical practice\n\nExclusion Criteria:\n\n* None",{"count":100,"type":21},5000,"The primary purpose of this study is to investigate the characteristics of amyloid related imaging abnormalities (ARIA) and investigate the treatment continuation status (e.g., continuation, interruption) after the onset of ARIA in routine clinical practice in participants treated with lecanemab.",[103],"Alzheimer's Disease",[105,106,107],"Early Alzheimer's Disease","Lecanemab","ARIA","2026-01-22",{"date":110,"type":32},"2026-01-23",{"date":112,"type":32},"2024-02-14",{"date":114,"type":21},"2027-12-31",{"name":38,"class":39},3,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":124,"sex":16,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},"100383348","phase-1-study-to-evaluate-the-pharmacokinetics-pk-of-e7090-herein-referred-to-as-tasurgratinib-and-its-metabolite-in-participants-with-mild-and-moderate-hepatic-impairment-compared-to-healthy-participants-100383348","NCT04271488","Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy Participants","An Open-label Parallel-Group Study to Evaluate Pharmacokinetics of E7090 and Its Metabolite in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects","Inclusion Criteria:\n\n1. Body mass index (BMI) between 18 to 40 kilogram per square meter (kg\u002Fm\\^2).\n2. For Cohorts A and B: stable hepatic impairment conforming to Child-Pugh classification A and B.\n3. For Cohort C: healthy participants matched to participants with hepatic impairment with regard to age (+\u002F-10 years), body weight (+\u002F-20 percent \\[%\\]), race and gender, and as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations.\n\nExclusion Criteria:\n\nKey Exclusion for all Participants:\n\n1. Following ocular disorders\n\n   1. Current evidence of Grade 2 or higher corneal disorder\n   2. Current evidence of active macular disorder (example, Age-related macular degeneration, central serous chorioretinal disease)\n2. Known to be human immunodeficiency virus (HIV) positive at Screening.\n3. A prolonged QT\u002FQTc interval (\\[QT interval using Fridericia's formula\\] QTcF greater than (\\>) 480 millisecond \\[ms\\]) demonstrated on ECG.\n\nAdditional Exclusion Criteria for Hepatically Impaired Participants (Cohorts A and B)\n\nIn addition to the Exclusion Criteria above for all participants, other standard exclusion criteria for participants with hepatic impairment will be used. These include:\n\n1. Any significant acute medical illness (such as new conditions or exacerbation of pre-existing conditions) within 8 weeks of dosing.\n2. Presence of severe ascites, edema, or uncontrolled hepatic encephalopathy\n3. The participant's standard therapy\u002Fconcomitant medication for diseases related to hepatic disease has not remained stable\u002Funchanged for at least two weeks before dosing of study drug.\n\nAdditional Exclusion Criteria for Healthy participants (Cohort C)\n\nIn addition to the Exclusion Criteria for all participants, other standard exclusion criteria for healthy participants in Phase 1 studies will be used. These include:\n\n1. Syphilis as demonstrated by positive serology at Screening.\n2. Any abnormal finding based on physical examination, assessment of vital signs, ECG, or laboratory test results that requires treatment or clinical follow up based on investigators opinion.",true,"20 Years","79 Years",{"count":128,"type":21},18,[130],"PHASE1","The primary purpose of the study is to evaluate the effects of mild and moderate hepatic impairment on PK of tasurgratinib after a single dose administration.",[133],"Hepatic Impairment",[133,135,136],"E7090","Tasurgratinib",{"date":110,"type":32},{"date":139,"type":32},"2020-02-27",{"date":141,"type":21},"2026-11-30",{"name":38,"class":39},8,""]