[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tiziana Life Sciences LTD\",\"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,[8,41,69],{"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},"100582847","phase-2-a-phase-2a-study-of-foralumab-nasal-in-patients-with-multiple-system-atrophy-msa-100582847",false,"NCT06868628","A Phase 2a Study of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)","A Phase 2a Study to Evaluate Microglial Activation, Safety, and Clinical Effects of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)","Inclusion Criteria:\n\n* Subjects with a clinical diagnosis of Clinically Established or Clinically Probable Multiple System Atrophy in accordance with 2022 MDS diagnostic criteria.\n* Age 30 to 85 years, at the time of signing the informed consent.\n* Stable dopaminergic treatment for at least 4 weeks before enrollment.\n* Adequate hematologic parameters without ongoing transfusion support: Hemoglobin (Hb) ≥ 9 g\u002FdL; Platelets ≥ 100 x 109 cells\u002FL.\n* Creatinine ≤ 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ≥ 60 mL\u002Fminute x 1.73 m2 per the Cockcroft-Gault formula.\n* Total bilirubin ≤ 2 times the upper limit of normal (ULN) unless due to Gilbert's disease.\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN.\n* QT interval corrected for rate (QTcF) ≤ 470 msec for women and ≤ 450 msec for men on the ECG obtained at Screening.\n* Negative urine pregnancy test within 7 days prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months). Sexually active WCBP and male patients must agree to use highly effective methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 90 days after the completion of study treatment.\n* Patients whose immunizations are fully up to date at the Screening, according to the assessment of their primary care physician and neurologist.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis or suspicion of other cause for Parkinsonism or a known alternate neurologic diagnosis.\n* Female patient who is pregnant, lactating, breastfeeding, or planning to become pregnant during study.\n* Individuals with claustrophobia who cannot tolerate the study procedures\n* Non-MRI-compatible implanted devices.\n* Low-affinity binders for translocator protein (TSPO) PET ligands.\n* Systemic corticosteroid treatment in the past four weeks (excluding nasal or local treatment).\n* Individuals with significant cognitive impairment (i.e., MoCA score less than or equal to 20).\n* Brain MRI indicative of significant abnormalities that interfere with PET-MRI co-registration (i.e., large prior hemorrhage or multiple infarcts).\n* Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina, or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV or hereditary long QT syndrome.\n* Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, except for antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care.\n* Patients who test positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) or positive Epstein-Barr virus (EBV) IgM at the Screening Visit.\n* Past medical history of a hematologic or solid malignancy.\n* Treatment with chronic immunosuppressives such as interferon, glatiramer acetate, fingolimod, Siponimod, dimethyl fumarate, or natalizumab within the past 90 days.\n* Inability to tolerate nasally administered medications.\n* Nasal corticosteroids, nasal antihistamines, nasal flu dosing within the past 30 days, or anticipated need during the study.\n* Chronic rhinitis, deviated septum, nasal polyps, history of sinusitis treated within the past 8 months.\n* Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, primary Sjögren's Syndrome, asthma, or type 1 diabetes.\n* Neutropenia or an absolute neutrophil count of \\\u003C 1,000 cells\u002FmL or other indicators of severe immunosuppression.\n* Severe lymphopenia or an absolute lymphocyte count of \\\u003C 500 cells\u002FmL\n* Patients with a history of gadolinium allergy.\n* A recent clinically significant active infection requiring treatment with antibiotics or other anti-infective agents within the past 15 days.\n* Any other medical or surgical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results.\n* Unable or unwilling to comply with protocol requirements.\n* Active COVID-19 disease.\n* COVID-19 vaccine within past 10 days or any other vaccine within past 7 days (at dosing).","ALL","30 Years","85 Years",{"count":20,"type":21},5,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","A Phase 2a Study of Foralumab Nasal in Patients with Multiple System Atrophy (MSA)",[27],"Multiple System Atrophy","RECRUITING","2026-06-08",{"date":31,"type":32},"2026-06-10","ACTUAL",{"date":34,"type":32},"2025-05-19",{"date":36,"type":21},"2027-04-01",{"name":38,"class":39},"Tiziana Life Sciences LTD","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":40},"100584559","phase-2-nasal-foralumab-in-patients-with-non-active-secondary-progressive-multiple-sclerosis-100584559","NCT06890923","Nasal Foralumab in Patients With Non-Active Secondary Progressive Multiple Sclerosis","An Open Label, Multicenter Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients","TILS-022","Inclusion Criteria:\n\n* Subjects must have enrolled in and successfully completed TILS-021 within the preceding 90 days, including End of Treatment and End of Study assessments.\n* Screening clinical laboratory studies are within the normal ranges or within the parameters specified below, and clinically acceptable in the opinion of the Investigator. Exceptions must be approved by the Clinical Research Organization or Sponsor's Medical Monitor.\n* Adequate hematologic parameters without ongoing transfusion support:\n\n  1. Hemoglobin (Hb) ≥ 9 g\u002FdL\n  2. Platelets ≥ 100 x 109 cells\u002FL\n* Creatinine ≤ 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ≥60 mL\u002Fminute x 1.73 m2 per the Cockcroft-Gault formula\n* Total bilirubin ≤ 1.5 times the ULN unless due to Gilbert's disease.\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 times ULN.\n* Negative urine pregnancy test within 7 days prior to the first dose of study therapy for women of childbearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months).\n* Sexually active women of childbearing potential and male patients must agree to use two effective methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptives; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study, and for 90 days after the completion of study treatment.\n* Immunizations are current and up to date as adjusted for disease status and prior\u002Fcurrent treatments and documented by the subject's treating neurologist.\n* Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Subjects that terminated TILS-021 early as defined as not undergoing an End of Treatment visit.\n* Subjects that terminated TILS-021 early as defined as not undergoing an End of Study visit.\n* Subjects that terminated TILS-021 due to any adverse events.\n* Corticosteroid use (oral or intravenous) within the last 60 days or anticipated need for such treatment during the study period.\n* Current use or use within 30 days prior to the Screening Visit of interferon, glatiramer acetate, fingolimod, siponimod, dimethyl fumarate, ponesimod, ozanimod, cyclosporin, methotrexate, azathioprine, mycophenolate mofetil, natalizumab or any other chronic immunosuppressive medication. Concomitant immunomodulatory or immunosuppressant treatments for MS are not permitted during study participation.\n* Patient in whom the need to start or stop other pharmacologic treatment for MS is expected during the time of the study or the need for initiation of B cell depleting therapies (e.g.: ocrelizumab, ofatumumab, ublituximab, rituximab) during the study.\n* Use of B cell depleting therapies (e.g.: ocrelizumab, ofatumumab, ublituximab, rituximab) at any time during study TILS-021 or after the patient has completed TILS-021 is not permitted.\n* Subjects with any previous exposure to alemtuzumab, cyclophosphamide, cladribine, mitoxantrone, or daclizumab.\n* Prior use of autologous hematopoietic stem cell transplantation or stem cell therapy.\n* Nasal corticosteroids, nasal antihistamines, nasal flu dosing within the past 60 days.\n* Active COVID-19 disease; according to FDA guidelines.\n* Female patient who is pregnant, lactating, breastfeeding, or planning on becoming pregnant during the study. Female patients of childbearing age will undergo a serum pregnancy test at Screening, but prior to receiving their first dose, and be excluded from the study if positive. Urine pregnancy testing will be carried out prior to each dosing cycle, and the subject's study participation will be stopped if there is a positive result. Pregnancy testing will also be performed prior to each MRI imaging session and participation in the imaging session and the study will be terminated if positive.\n* Any history of malignancy or active malignancy. This includes any skin cancers at any time.\n* Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, or type 1 diabetes.\n* Patients with a history of gadolinium allergy\u002Fcontraindications or any other contraindications to MRI, such as metal implants, chronic renal disease and an eGRF of \\\u003C30 mL\u002Fminute or claustrophobia. Or who are unable to lay flat in the PET or MRI scanner for the duration of the studies.\n* Known positivity for human immunodeficiency virus, hepatitis B virus surface antigen (HBsAg), or hepatitis C virus or tuberculosis at Screening. If the subject has a history of positivity for any of these diseases, they are excluded even if current Screening is negative.\n* Any nasal pathology such as clinically significant deviated septum, nasal polyps, chronic rhinitis, or a history of sinusitis diagnosed or treated in the past 12 months.\n* Clinically significant cardiac condition or ECG abnormality at Screening or by history. An ECG will be done prior to each dosing cycle and patients will be excluded or treatment discontinued for any significant ECG abnormality.\n* Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results.\n* Other than nasal foralumab, receipt of an investigational drug\u002Fbiological product in the past 30 days of Screening, or concurrent receipt of an investigational drug during this study, other than the product under study.","18 Years","75 Years",{"count":52,"type":21},55,[24],"Only subjects that have completed TILS-021, a Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients are eligible to be enrolled in TILS-022. TILS-022 is a 6-month open-label extension study with an opportunity for dose to be escalated based on the subject's clinical status.\n\nAll subjects initiate dosing in this trial at a dose of nasal foralumab 50 µg 3 days a week (Monday, Wednesday, and Friday) for 2 weeks, followed by a 1-week rest, comprising a 3-week cycle. At week 12, the dose may be escalated to 100 µg according to pre-defined dose escalation rules. Study TILS-022 is intended to ensure all participants in TILS-021, a placebo-controlled study, will be able to receive open-label nasal foralumab for 6 months. The option to extend this trial for longer than 6 months will be explored with FDA by the Sponsor.",[56],"Non-Active Secondary Progressive Multiple Sclerosis",[56,58,59,60],"Multiple Sclerosis","Foralumab","phase 2","2025-06-03",{"date":63,"type":32},"2025-06-06",{"date":65,"type":32},"2025-03-04",{"date":67,"type":21},"2026-08-30",{"name":38,"class":39},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":50,"enrollmentInfo":4,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":89,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":90,"locationsCount":40},"100577748","intermediate-size-patient-population-expanded-access-foralumab-in-non-active-secondary-progressive-ms-patients-100577748","NCT06802328","Intermediate-Size Patient Population Expanded Access: Foralumab in Non-Active Secondary Progressive MS Patients","An Intermediate-Size Patient Population Expanded Access Treatment Protocol Evaluating the Safety, Tolerability and Immune Effects of the Nasal Anti-CD3 Monoclonal Antibody Foralumab in Non-Active Secondary Progressive MS Patients Foralumab Nasal","Inclusion Criteria:\n\n* Confirmed diagnosis of MS (according to the 2010 McDonald criteria).\n* Age 25-75 years old.\n* Clinical diagnosis of non-active SPMS, as defined by the absence of relapses for 2 years.\n* MRI imaging consistent with a diagnosis of MS at any time point.\n* Score on the Expanded Disability Status Scale (EDSS) of 2.5-7.5.\n* Have failed standard of care treatment and continued to decline clinically for at least 6 months.\n* Adequate hematologic parameters without ongoing transfusion support:\n\n  1. Hemoglobin (Hb) ≥ 9 g\u002FdL\n  2. Platelets ≥ 100 x 109 cells\u002FL\n* Creatinine ≤ 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ≥ 60 mL\u002Fminute x 1.73 m2 per the Cockcroft-Gault formula.\n* Total bilirubin ≤ 2 times the upper limit of normal (ULN) unless due to Gilbert's disease.\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN.\n* QT interval corrected for rate (QTcF) ≤ 470 msec for women and ≤ 450 msec for men on the ECG obtained at Screening\n* Negative urine pregnancy test within 7 days prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months). Sexually active WCBP and male patients must agree to use highly effective methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 90 days after the completion of study treatment.\n* Patients whose immunizations are fully up to date at the Screening, according to the assessment of their primary care physician and neurologist.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Need for corticosteroid treatment (oral or intravenous) within the past 30 days or anticipated need within 30 days of foralumab therapy initiation.\n* Treatment with Ocrevus® (ocrelizumab), Rituxun® (rituximab), Kesimpta® (ofatumumab), Truxima® (rituximab-abbs) within the past 90 days.\n* Treatment with Lemtrada® (alemtuzumab) and Mavenclad® (cladribine) within the past 1 year.\n* Treatment with chronic immunosuppressives such as interferon, glatiramer acetate, fingolimod, siponimod, dimethyl fumarate or natalizumab within the past 90 days.\n* Inability to tolerate nasally administered medications.\n* Nasal corticosteroids, nasal antihistamines, nasal flu dosing within the past 30 days, or anticipated need during the study.\n* Chronic rhinitis, deviated septum, nasal polyps, history of sinusitis treated within the past 8 months.\n* Active COVID-19 disease.\n* COVID-19 vaccine within past 10 days or any other vaccine within past 7 days (at dosing).\n* Female patient who is pregnant, lactating, breastfeeding, or planning on becoming pregnant during study.\n* Female patients of childbearing age will undergo a pregnancy test and be excluded from the study if positive.\n* Active malignancy within 5 years.\n* Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, or type 1 diabetes.\n* Neutropenia or an absolute neutrophil count of \\\u003C 1,000 cells\u002FmL or other indicators of severe immunosuppression.\n* Patients with a history of gadolinium allergy.\n* Screening labs outside of the normal range; EBV IgM positive patients with clinical signs will not receive study drug.\n* Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina, or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV or hereditary long QT syndrome.\n* Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, except for antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care.\n* Patients who test positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV) at the Screening Visit.\n* A recent clinically significant active infection requiring treatment with antibiotics or other anti-infective agents within the past 15 days.\n* Patients whose immunizations are not fully up to date at the Screening Visit, as assessed by their primary care physician and neurologist.\n* Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results.\n* Unable or unwilling to comply with protocol requirements.","25 Years","EXPANDED_ACCESS","This is an open-label, intermediate-size patient population expanded access treatment study utilizing 1 dose level of nasal Foralumab (50 µg\u002Fdosing day) with the possibility of increasing to 100 µg\u002Fdosing day. The goal of this expanded access clinical trial is to evaluate safety, tolerability, and immune effects of intranasal Foralumab in non-active secondary progressive multiple sclerosis patients. The primary objective is to treat patients who have failed current available therapy. Participants will visit the clinic for testing and follow-up every cycle (3 weeks) while administering the medication at home if able three times weekly.",[56],[81,82,83,84,85,86,87],"multiple sclerosis","non-active secondary progressive multiple sclerosis","MS","expanded access","anti-cd3 monoclonal antibody","foralumab","nasal","AVAILABLE",{"date":63,"type":32},{"name":38,"class":39},""]