[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577748":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":21,"responsibleParty":43,"collaborators":7,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":7,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":7,"targetDuration":7,"studyType":55,"phases":7,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":24,"whyStopped":7,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Tiziana Life Sciences LTD","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DRUG","Foralumab TZLS-401 50 µg","Foralumab 50 µg\u002Fdosing day for patients who have failed current therapies. Patients will be dosed in 3-week cycles, with foralumab dosing on Days 1, 3 and 5 of the first and second weeks, followed by a \"rest week\". Patients will receive Day 1 doses of nasal foralumab under supervision at the Center for Clinical Investigation at BWH.",[14,19],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Tiziana","CONTACT","1-833-849-4262","ms@tizianalifesciences.com",{"name":20,"role":16,"phone":17,"phoneExt":7,"email":18},"Keeren Shah",[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Brigham and Women's Hospital","AVAILABLE","Boston","Massachusetts","02115","United States","US",{"type":31,"coordinates":32},"Point",[33,34],-71.05977,42.35843,{"lat":34,"lon":33},[37,40],{"name":38,"role":16,"phone":39,"phoneExt":7,"email":18},"Research Coordinator","8338494262",{"name":41,"role":42,"phone":7,"phoneExt":7,"email":7},"Tanuja Chitnis","PRINCIPAL_INVESTIGATOR",{"type":44,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100577748","intermediate-size-patient-population-expanded-access-foralumab-in-non-active-secondary-progressive-ms-patients-100577748",false,"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.","ALL","25 Years","75 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.",[58],"Non-Active Secondary Progressive Multiple Sclerosis",[60,61,62,63,64,65,66],"multiple sclerosis","non-active secondary progressive multiple sclerosis","MS","expanded access","anti-cd3 monoclonal antibody","foralumab","nasal","2025-06-03",{"date":69,"type":70},"2025-06-06","ACTUAL",{"name":5,"class":6},1]