[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AB Science\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":122},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,68,94],{"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},"100606356","phase-3-efficacy-and-safety-of-masitinib-in-combination-with-soc-versus-placebo-in-the-treatment-of-als-patients-100606356",false,"NCT07174492","Efficacy and Safety of Masitinib in Combination With SoC Versus Placebo in the Treatment of ALS Patients","A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Groups, Phase 3 Trial to Compare the Efficacy and Safety of Masitinib in Combination With Standard of Care Versus Placebo in Combination With Standard of Care in the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)","Inclusion Criteria:\n\n1. The patient must have been diagnosed with clinically probable or definite ALS based on the World Federation of Neurology Revised El Escorial criteria.\n2. Patients aged 18 to 80 years old and who have either familial or sporadic ALS.\n3. Patients must have been treated with a stable dose of Riluzole (100 mg\u002Fday) for at least 30 days before the entering the trial.\n4. If they are taking it, patients must have been on a stable dose for at least 30 days before study entry;\n5. Patients should have experienced the first symptom of ALS no longer than 36 months before the screening visit\n6. Disease Progression Rate: The ALSFRS-R progression rate (measured between onset and screening) should be between 0.3 and 1.1 point\u002Fmonth\n7. ALSFRS-R Total Score: At screening and baseline, patients need to meet the following criteria:\n\n   Item #3: At least 3 points. Item #12: At least 2 points. Other Items: At least 1 point on each of the remaining 10 items\n8. Contraception: Female patients of childbearing potential and male patients must use a highly effective method of contraception during the trial and for a specified period afterwards\n\nExclusion Criteria:\n\n1. Patients should not have any significant neurological, psychiatric, systemic or organic disease that could interfere with the trial\n2. Hypersensitivity to masitinib excipients or riluzole\n3. Lung function: patients with an FVC (forced vital capacity) of less than 70% of the predicted normal value for their gender, height, and age are excluded\n4. Patients with a weight less than 41 kg and a BMI (body mass index) less than 18 or greater than 35 kg\u002Fm² are not eligible.\n5. Pregnant or nursing female patients at screening and baseline are excluded\n6. Patients with pre-existing conditions that may be aggravated with the use of masitinib (severe skin toxicities or reactions, liver disorders, severe renal impairment, viral infections, cancer, severe cardiovascular disease, high risk of heart attack and\u002For stroke).\n7. Patient treated concomitantly with medications that may interact with masitinib\n8. Participants with a significant pulmonary disorder not attributed to ALS or who require treatments that might complicate the evaluation of the effect of ALS on respiratory function\n9. Previous treatment with masitinib","ALL","18 Years","80 Years",{"count":20,"type":21},412,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The objective is to compare the efficacy and safety of masitinib in combination with riluzole versus matched placebo in combination with riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS).",[27],"Amyotrophic Lateral Sclerosis (ALS)","NOT_YET_RECRUITING","2025-10-02",{"date":31,"type":32},"2025-10-03","ACTUAL",{"date":34,"type":21},"2026-01-01",{"date":36,"type":21},"2029-12-31",{"name":38,"class":39},"AB Science","INDUSTRY",1,{"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":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100482602","phase-3-masitinib-in-patients-with-mild-alzheimers-disease-100482602","NCT05564169","Masitinib in Patients With Mild Alzheimer's Disease","A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Masitinib as add-on Therapy in Patients With Mild Alzheimer's Disease, Treated With Standard of Care","Main inclusion criteria include:\n\n1. Patient with clinical diagnosis of Alzheimer's disease based on criteria defined by IWG (International Working Group on Alzheimer's disease) at screening visit.\n2. Patients with ADCS-ADL score at screening visit and baseline visit \\\u003C 73\n3. Patient with MMSE ≥ 21 and ≤ 25 at screening visit and baseline visit.\n4. Patient with Alzheimer's Disease biomarker profile at screening visit:\n\n   * A positive amyloid PET scan\n   * Alternatively, positive a-beta AND p-tau results OR an abnormal p-tau\u002Fa-beta ratio in CSF analysis. Before randomization, the results will be verified centrally.\n5. If patients are treated with cholinesterase inhibitors (donepezil, rivastigmine or galantamine), and\u002For memantine. They should have been at stable dose for a minimum of 6 months at baseline visit, with no changes foreseen in therapy throughout the trial.\n6. If receiving a supplement for cognition (eg, gingko biloba, omega-3 polyunsaturated fatty acid, vitamin E, curcumin, souvenaid) patients must have been taking it at stable dose for at least 4 months prior to screening visit.\n7. Patients with a caregiver who, at screening and baseline visits, agrees to accompany the participant to all trial visits, supervise compliance with procedures, provide detailed information, has sufficient contact (≥1 hour\u002Fday for ≥3 days\u002Fweek or as deemed sufficient by the Investigator), can read, understand, and speak the designated language, and is cognitively capable of fulfilling trial requirements.\n\nMain exclusion criteria include:\n\nRelated to disease\n\n1. Patients with any other cause of dementia shown by MRI findings and neurological examination\n2. Systemic conditions known to cause dementia, e.g., hypothyroidism, untreated vitamin B12 or folic acid deficiency, niacin deficiency, neurosyphilis, HIV infection at screening visit.\n3. Patients with substance-induced dementia, Alzheimer's disease with delirium, severe delusions (e.g., NPI delusion score ≥ 4), psychosis or antipsychotic use, or a history of significant psychiatric disorders at the screening visit.\n4. Patients with a significant unexplained improvement or decline in overall status on ADAS-Cog and ADCS-ADL at screening and baseline compared to previous assessments, and those whose scores are not in line with their medical history.","50 Years",{"count":50,"type":21},600,[24],"Masitinib is an orally administered tyrosine kinase inhibitor that targets activated cells of the neuroimmune system (mast cells and microglia). Study AB21004 will evaluate masitinib as an adjunct to cholinesterase inhibitor and\u002For memantine in patients with mild-to-moderate Alzheimer's disease.",[54],"Alzheimer Disease",[56,57,58,59],"Alzheimer's Disease","Mast Cells","Microglia","Tyrosine kinase inhibitor","2025-09-30",{"date":31,"type":32},{"date":63,"type":21},"2026-06",{"date":65,"type":21},"2029-12",{"name":38,"class":39},9,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100455516","phase-1-ab8939-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100455516","NCT05211570","AB8939 in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","A Phase 1\u002F2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","DOSE ESCALATION STUDY\n\nKey Inclusion Criteria:\n\n* Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.\n* Patients with documented diagnosis of refractory melyodisplastic syndrome in second or third line of treatment, and with high risk at prognosis based on the IPSS-R scoring system.\n* ECOG performance status ≤ 1\n* Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures\n* Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies\n\nKey Exclusion Criteria:\n\n* Patients eligible to a standard of care\n* Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion\n* Patients diagnosed with acute promyelocytic leukemia (M3)\n* Patients with clinically active CNS leukemia\n* Patients with HSCT within 100 days prior to the first administration of AB8939\n* Women who are lactating\u002Fbreastfeeding or who plan to breastfeed while on study\n* Women with a positive pregnancy test\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply\n\nEXPANSION COHORT STUDY\n\nKey Inclusion Criteria:\n\n* Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.\n* ECOG performance status ≤ 2\n* Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures\n* Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies\n\nKey Exclusion Criteria:\n\n* Patients eligible to a standard of care\n* Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion\n* Patients diagnosed with acute promyelocytic leukemia (M3)\n* Patients with clinically active CNS leukemia\n* Patients with HSCT within 100 days prior to the first administration of AB8939\n* Women who are lactating\u002Fbreastfeeding or who plan to breastfeed while on study\n* Women with a positive pregnancy test\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply",{"count":76,"type":21},78,[78,79],"PHASE1","PHASE2","The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.",[82,83,84],"Acute Myeloid Leukemia Refractory","Acute Myeloid Leukemia, in Relapse","Myelodysplastic Syndrome Acute Myeloid Leukemia","RECRUITING","2025-09-29",{"date":29,"type":32},{"date":89,"type":32},"2022-06-01",{"date":91,"type":21},"2026-12",{"name":38,"class":39},10,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":25,"conditions":105,"keywords":107,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100295541","phase-3-efficacy-and-safety-of-masitinib-versus-placebo-in-the-treatment-of-als-patients-100295541","NCT03127267","Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients","Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Riluzole Versus Placebo in Combination With Riluzole in the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)","Main inclusion criteria include:\n\n* Patients diagnosed with laboratory supported probable, clinically probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria\n* Patient with a familial or sporadic ALS\n* ALS disease duration from diagnosis no longer than 24 months at the screening visit\n* Patient treated with a stable dose of riluzole (100 mg\u002Fday) for at least 12 weeks days prior to the baseline visit\n* Patient with an ALSFRS-R score progression between onset of the disease and screening of \\> 0.3 per month, confirmed with an ALSFRS-R score progression of ≥ 1 point during a 12-week run-in period between screening and randomization.\n* Patient with a score, at screening, of at least 26 overall, including a score of at least 3 on item #3 and at least 2 on each of the 12 ALSFRS-R individual component items and with a score, at randomization, of at least 2 on each of the 12 ALSFRS-R individual component items\n\nMain exclusion criteria include:\n\n* Patient with dementia or significant neurological, psychiatric, systemic or organic disease, uncontrolled or that may interfere with the conduct of the trial or its results\n* Patient with a FVC \\\u003C 60% predicted normal value for gender, height, and age at screening and baseline\n* Pregnant, or nursing female patient","81 Years",{"count":103,"type":21},495,[24],[106],"Amyotrophic Lateral Sclerosis",[106,108,59,109,110,111,112],"ALS","Lou Gehrig's disease","Charcot's disease","Motor Neuron disease","MND","2025-09-08",{"date":115,"type":32},"2025-09-12",{"date":117,"type":32},"2021-02-02",{"date":119,"type":21},"2027-12",{"name":38,"class":39},56,""]