[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsing-multiple-sclerosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsing-multiple-sclerosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,51,77,101,122,143,173,202,225,248,281,305,326],{"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":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100581128","phase-3-efficacy-and-safety-of-remibrutinib-after-switching-from-ocrelizumab-in-participants-living-with-relapsing-multiple-sclerosis-100581128",false,"NCT06846281","Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.","A Randomized, Open-label, Parallel-group, Non-inferiority Study Comparing Efficacy, Safety, and Tolerability of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis, Followed by Open-label Treatment With Remibrutinib","Key Inclusion Criteria:\n\n* Male or female aged 40 to 70 years (inclusive)\n* Diagnosis of RMS according to the 2017 McDonald diagnostic criteria\n* Treated with ocrelizumab according to routine clinical practice and at standard dose\n* Neurologically stable within 30 days\n* Suitable to be switched to remibrutinib based on physician judgement or patient preference\n\nKey Exclusion Criteria:\n\n* Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria\n* History of clinically significant Central Nervous System disease or neurological disorders\n* History of confirmed Progressive Multifocal Leukoencephalopathy or neurological symptoms consistent\n* Active clinically significant systemic bacterial, viral, parasitic or fungal infections\n* Active, chronic disease of the immune system other than MS\n* Severe cardiac disease or significant findings on the ECG\n* Participant who is unable to undergo MRI scans\n* History of life-threatening infusion or injection reaction related to ocrelizumab\n\nOther inclusion and exclusion criteria may apply","ALL","40 Years","70 Years",{"count":20,"type":21},360,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).",[27],"Relapsing Multiple Sclerosis",[29,30,31,32,33,34,35,36,37],"MS","RMS","Remibrutinib","LOU064","Ocrelizumab","Age","MRI","T2 lesions","NEDA-3","RECRUITING","2026-06-25",{"date":41,"type":42},"2026-06-26","ACTUAL",{"date":44,"type":42},"2025-06-23",{"date":46,"type":21},"2031-06-24",{"name":48,"class":49},"Novartis Pharmaceuticals","INDUSTRY",120,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100609874","phase-2-study-to-assess-effects-of-ublituximab-in-pediatric-participants-with-relapsing-forms-of-multiple-sclerosis-100609874","NCT07220252","Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis","Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)","Inclusion Criteria for Part A and Part B:\n\n1. Diagnosis of RMS.\n2. EDSS at screening: 0-5.5, inclusive.\n3. Neurologic stability for ≥ 30 days prior to screening, and between screening and Week 1 Day 1 (W1D1).\n\nInclusion Criteria for Part C:\n\n1\\. Participants must have completed Part A (Week 24 visit) or Part B (Week 96 visit) to be eligible for Part C.\n\nExclusion Criteria for Part A and B:\n\n1. Known presence or suspicion of other neurologic disorders that may mimic MS.\n2. Prior treatments:\n\n   1. Systemic corticosteroids (\\>0.1 milligrams\u002Fkilogram\u002Fday \\[mg\u002Fkg\u002Fday\\], or \\>5 milligrams\u002Fday \\[mg\u002Fday\\] of prednisone equivalent) or adrenocorticotropic hormone (ACTH) within 30 days prior to the screening MRI scan (note: Topical, ophthalmic, or inhaled corticosteroids are permitted).\n   2. High dose intravenous immunoglobulin (IVIG) or subcutaneous IG (SCIG) within 2 months prior to W1D1.\n   3. Treatment with anti-CD20 or other B cell directed treatment at any time.\n   4. Treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone at any time.\n\nAdditional Exclusion Criteria for Part B Only (Relevant to Fingolimod Treatment):\n\n1. Treatment with fingolimod or other sphingosine-1 phosphate-1 (S1P1) modulators at any time.\n2. The following antiarrhythmic drugs at Screening: Class Ia anti-arrhythmics.\n\nExclusion Criteria for Part C:\n\n1\\. If the absolute lymphocyte count (ALC) is outside the specified range the participant will not be eligible to receive ublituximab in Part C.\n\nNote: Other protocol-specified inclusion\u002Fexclusion criteria may apply","10 Years","17 Years",{"count":61,"type":21},240,[63,24],"PHASE2","The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (\\\u003C)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to less than or equal to (≤)40 kg with RMS (Part A) and to evaluate the non-inferiority of ublituximab compared with fingolimod in pediatric RMS participants with body weight ≥ 25 kg (Part B). The study will further evaluate long-term safety and efficacy of ublituximab in RMS in pediatric participants during its extension period (Part C).",[27],"NOT_YET_RECRUITING","2026-06-19",{"date":69,"type":42},"2026-06-23",{"date":71,"type":21},"2026-08-01",{"date":73,"type":21},"2033-06-30",{"name":75,"class":49},"TG Therapeutics, Inc.",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100549418","a-study-evaluating-the-real-world-experience-of-participants-treated-with-briumvi-ublituximab-xiiy-for-relapsing-multiple-sclerosis-rms-100549418","NCT06433752","A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)","REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE)","ENABLE","Inclusion Criteria:\n\n1. Confirmed Multiple Sclerosis (MS) diagnosis.\n2. Participants who have not received any BRIUMVI® (ublituximab-xiiy) infusion prior to study start. Participants who have been prescribed BRIUMVI® (ublituximab-xiiy) but have not yet received their first infusion on Day 1 of 150 milligrams (mg) can be included.\n\nExclusion Criteria:\n\n1. Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 4 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration or any non-live vaccines within 2 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration.\n2. Any active infection (e.g., active Hepatitis B virus \\[HBV\\])\n3. Concurrent participation in any interventional MS trials, or planned concurrent treatment with other Multiple Sclerosis Disease Modifying Therapy (MS DMT) during the study period.","18 Years",{"count":87,"type":21},2000,"OBSERVATIONAL","The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting",[27,91],"Multiple Sclerosis","2026-06-17",{"date":94,"type":42},"2026-06-18",{"date":96,"type":42},"2024-07-22",{"date":98,"type":21},"2032-04-01",{"name":75,"class":49},90,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":109,"minAge":85,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100527111","a-study-evaluating-the-presence-and-concentration-of-briumvi-ublituximab-in-breast-milk-100527111","NCT06143514","A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk","A Post-marketing Study Evaluating the Presence and Concentration of BRIUMVI™ in Breast Milk (PROVIDE)","PROVIDE","Inclusion Criteria:\n\nMaternal Criteria:\n\n* Participant has independently decided to be treated with BRIUMVI™ prior to providing consent to participate in the study\n* Diagnosis of RMS, to include clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS)\n* Willing to breastfeed or pump regularly during the study period to maintain milk supply and exclusively pump breast milk for the 24-hour period of breast milk collection Day 1 post IV dose\n* Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning\n\nInfant Criteria:\n\n* Gestational age at delivery ≥35 weeks\n* Birthweight \\> 10th percentile\n* Weight \\> 10th percentile as reported by the mother at the time of enrollment\n\nExclusion Criteria:\n\nMaternal Criteria:\n\n* Any active infection or other condition that would prevent the individual from breastfeeding\n* History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts\n* History of mastectomy\n* Evidence of mastitis or any other significant active infection at Day 1 (pre-dose) that would prevent collection of milk from one or both breasts\n* Current use of drugs known to transfer to the breast milk and with established or potential deleterious effects for the infant, including but not limited to aspirin (risk of Reye's syndrome), tetracyclines or fluoroquinolones\n\nInfant Criteria:\n\n\\- Any abnormality noted or clinically significant medical condition, including cardiac, pulmonary, and liver disease, glucose instability, or active infection at the time of screening that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the trial difficult or would put the infant at risk by participating in the study","FEMALE",{"count":111,"type":21},16,"The primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms of multiple sclerosis (RMS).",[27],[91],{"date":94,"type":42},{"date":117,"type":42},"2024-03-26",{"date":119,"type":21},"2026-06-30",{"name":75,"class":49},5,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},"100506713","phase-3-study-to-evaluate-safety-efficacy-and-pharmacokinetics-pk-of-a-modified-regimen-of-ublituximab-100506713","NCT05877963","Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab","Evaluating Safety, Efficacy and Pharmacokinetics of a Modified Regimen of Ublituximab (ENHANCE )","ENHANCE","Inclusion Criteria:\n\n* Diagnosis of RMS (2017 Revised McDonald criteria).\n* Participants must meet one of the following prior treatment definitions:\n\n  1. Participants naïve to treatment.\n  2. Participants previously treated with a disease modifying therapy (DMT) who have discontinued treatment prior to consent and meet the washout requirements.\n* Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.\n* Neurologically stable for \\> 30 days prior to first dose of ublituximab.\n* Female participants of childbearing potential must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 6 months after the last dose of ublituximab.\n* Part C: participants currently treated with an anti-CD20 agent for at least 6 months and meet the washout requirements prior to W1D1.\n* Part C: Discontinuation of current anti-CD20 must be due to suboptimal experience\n\nExclusion Criteria:\n\n* History of any serious 3 Infusion Related Reaction (IRR) on prior anti-CD20 therapy.\n* Primary-progressive multiple sclerosis (PPMS) or inactive Secondary Progressive MS (SPMS).\n* Active chronic (or stable but treated with immune therapy) disease of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.).\n* Current evidence or known history of clinically significant infection, including: chronic, recurrent, or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment such as, but not limited to chronic urinary tract infection, chronic pulmonary infection with bronchiectasis, tuberculosis, or active hepatitis C virus (HCV).\n* Previous serious opportunistic or atypical infection.\n* Evidence of chronic active or history of hepatitis B virus (HBV) infection as evidenced by a detectable hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb), or chronic hepatitis C infection. Participants with positive hepatitis C virus antibody (HCV Ab) are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).\n* History or evidence (clinical, radiological, or biomarker) of suspected or confirmed progressive multifocal leukoencephalopathy (PML).\n* Receipt of any live or live-attenuated vaccines (including vaccines for varicella-zoster virus or measles) within 4 weeks prior to first study drug administration.\n* Participants requiring treatment with intravenous immune globulin (IVIG) for decreased immunoglobulins within the 12 months prior to W1D1.\n* Any active malignancies other than adequately treated basal, squamous cell or in situ carcinoma.\n* Participants who have ever received ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab (including for non-MS indications).\n\nNote: Other Inclusion\u002FExclusion criteria may apply.","65 Years",{"count":132,"type":21},800,[24],"The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.",[27],{"date":94,"type":42},{"date":138,"type":42},"2023-06-13",{"date":140,"type":21},"2027-12-01",{"name":75,"class":49},47,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":154,"conditions":155,"keywords":156,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100605341","phase-2-a-pharmacokinetics-pk-pharmacodynamics-pd-safety-and-tolerability-study-of-fenebrutinib-in-children-and-adolescents-with-relapsing-multiple-sclerosis-rms-100605341","NCT07161258","A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)","An Open-label, Single-arm Study to Evaluate Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis","FENerations1","Inclusion Criteria:\n\n* A diagnosis of RMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, and the revised 2017 McDonald Criteria and one or more of the following: at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd enhancing lesion on MRI within 6 month\n* Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points, inclusive\n* Children and adolescents must have received all childhood vaccinations as per local\u002Fnational recommendations for childhood vaccination against infectious diseases\n\nExclusion Criteria:\n\n* A diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS)\n* Co-morbid Conditions:\n* Potentially confounding neurological, somatic, or metabolic disorders\n* Current clinically significant psychiatric or medical illness\n* History of cancer, transplants, or bleeding disorders\n* Inability to complete an MRI scan or get gadolinium\n* Abnormal liver function tests or blood counts\n* Sensitivity or intolerance to any ingredient (including excipients) of fenebrutinib tablets\n* Active, recurrent, or chronic infections\n* Recent or anticipated use of prohibited medications\u002Ftreatments:\n* Certain disease-modifying therapy (DMT) and other immunosuppressants\n* Drugs interacting with fenebrutinib (Cytochrome P450 3A4 \\[CYP3A4\\] inhibitors)\n* Any other investigational therapy, anticoagulants, certain vaccines\n* A score of 4 or 5 on the \"last 6 months\" section of the screening SI section or \"yes\" on any item of the \"last 6 months\" Suicidal Behavior (SB) section of the C-SSRS or a positive answer on Question 9 of the Patient Health Questionnaire-9 Modified for Adolecents (PHQ-A) or significant risk of suicide, in the investigator's judgment",{"count":152,"type":21},12,[63],"This open label, single arm study will evaluate the PK and PD effects of fenebrutinib in children and adolescents with RMS aged between 10 and \\\u003C 18 years.\n\nThis study consists of a Dose Exploration Period and an Optional Extension Period. Eligible participants may choose to continue treatment with fenebrutinib in the optional extension period after completing the dose exploration period.",[27],[157,158,159,160,161,162],"Pediatric multiple sclerosis","Pediatric MS","Children MS","Children multiple sclerosis","Adolescent multiple sclerosis","Pediatric fenebrutinib","2026-06-05",{"date":165,"type":42},"2026-06-09",{"date":167,"type":42},"2025-10-06",{"date":169,"type":21},"2029-02-13",{"name":171,"class":49},"Hoffmann-La Roche",17,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":185,"conditions":186,"keywords":187,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},"100563563","phase-1-an-open-label-study-to-assess-the-safety-efficacy-and-cellular-kinetics-of-ytb323-in-relapsing-multiple-sclerosis-100563563","NCT06617793","An Open-label Study to Assess the Safety, Efficacy, and Cellular Kinetics of YTB323 in Relapsing Multiple Sclerosis","An Open-label, Multi-center, Phase 1\u002F2 Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Participants With Relapsing Multiple Sclerosis With Breakthrough Disease Activity During Previous Treatment With a Highly Efficacious Therapy","Inclusion Criteria:\n\n* Signed informed consent, and able to communicate well with the investigator and comply with the requirements of the study\n* Adequate renal, hepatic, cardiac, hematological, and pulmonary function\n* Male or female participants, ≥18 years to ≤60 years at screening, with diagnosis of RMS according to the 2017 McDonald diagnostic criteria Evidence of recent (i.e. within 1 year) breakthrough disease activity while at least 6 months on a highly efficacious therapy (any of the following): rituximab (Rituxan®), ocrelizumab (Ocrevus®), natalizumab (Tysabri®), ofatumumab (Kesimpta®), ublituximab (Briumvi®) or evidence of breakthrough disease activity within 2 years after the latest alemtuzumab infusion (Lemtrada®).\n\nEvidence of breakthrough disease activity is defined as one or more of the following:\n\n1. Confirmed Clinical MS relapse\n2. Persistent radiological activity defined by one of the following:\n\n   * ≥2 T1 gadolinium-enhancing lesions on a single MRI scan\n   * ≥1 T1 gadolinium-enhancing lesions on two or more separate MRI scans\n   * ≥2 new T2 lesions compared to a previous scan within a period ≤1 year\n\n     * Ambulatory patients (EDSS of 3 to 6 points, inclusive assessed outside of relapse)\n     * Disease duration less than 15 years\n     * Participants must receive or be current on all recommended vaccinations according to institutional, local, or global guidelines for immunocompromised patients at least 6-weeks prior to lymphodepletion\n\nExclusion Criteria:\n\n* Diagnosis of primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria at screening\n* History of or current clinically significant CNS disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic MS or ICANS at screening\n* Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, New York Heart Association (NYHA) Class III\u002FIV left ventricular failure, arrhythmia and uncontrolled hypertension within 6 months prior to screening), neurological disorders other than MS (including seizure disorders even when well controlled), psychiatric, pulmonary (including, history of or active severe respiratory disease, including Chronic Obstructive Pulmonary Disease, interstitial lung disease or pulmonary fibrosis), renal, hepatic, endocrine, metabolic (e.g. severe hypoproteinemia due to nephrotic syndrome), hematological disorders or gastrointestinal disease that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant, prior to screening\n* Have donated blood or experienced a loss of blood \\> 400 mL within 3 months prior screening, or longer if required by local regulations\n* Any prior stem cell therapy or organ transplantation or gene therapy\n* Any contraindications to LP, including but not limited to:\n\n  * Known or suspected structural abnormality of the lumbar spine that, in the opinion of the Investigator, may interfere with the performance of the LP, or increase the risk of the procedure for the participant\n  * Presence of risk for increased or uncontrolled bleeding including, but not limited to, vascular abnormalities or neoplasms at or near the LP site, disorders of the coagulation cascade, platelet function, or platelet count\n  * Participants on anticoagulants (e.g., warfarin) or antiplatelets \\[except for low-dose aspirin (100 mg\u002Fday or lower) and low-dose ibuprofen (600 mg\u002Fday or lower) which are allowable\\], are not eligible to participate\n* Participants not willing or able to take MRI scans as per protocol. Unable to undergo MRI due to for example claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply","60 Years",{"count":182,"type":21},28,[184,63],"PHASE1","This is an open-label, multi-center, non-confirmatory study to assess the safety, efficacy, and cellular kinetics of YTB323 in approximately 28 participants with Relapsing Multiple Sclerosis (RMS) with breakthrough disease activity during previous treatment with a highly efficacious therapy (BD-HET). The study design utilizes an ascending single dose design consisting of 3 sentinel cohorts followed by an expansion cohort.",[27],[188,189,190,91,29,27,30,191,192],"Chimeric Antigen Receptor T cells","CAR-T","YTB323","breakthrough disease activity during previous treatment with a highly efficacious therapy","BD-HET","2026-05-28",{"date":195,"type":42},"2026-05-29",{"date":197,"type":42},"2025-02-24",{"date":199,"type":21},"2030-10-01",{"name":48,"class":49},18,{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":224},"100465726","a-nis-evaluating-various-injectable-and-oral-treatments-in-patients-with-relapsing-multiple-sclerosis-100465726","NCT05344469","A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis","A Non-interventional Study Evaluating Injectable Treatments (Ofatumumab, Glatiramer Acetate and Interferon β1) and Oral Treatments (Teriflunomide, Dimethyl Fumarate and Diroximel Fumarate) in Patients With Relapsing Multiple Sclerosis [AIOLOS]","AIOLOS","Cohort 1 Inclusion Criteria:\n\n1. Signed informed consent must be obtained prior to participation in the study\n2. Male or female patients aged ≥18 years at enrollment\n3. Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018b)\n4. RMS with active disease as defined by Lublin et al. (2014)\n5. Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment\n6. Disability status at enrollment with an EDSS score of 0 to 2.5 (inclusive)\n7. Planned initiation or initiation within the past 14 days with an approved injectable DMT for MS as routine medical treatment\n\nCohort 2 Inclusion Criteria:\n\n1. Signed informed consent must be obtained prior to participation,\n2. Male or female patients aged ≥18 years at enrollment,\n3. Diagnosis of MS according to the 2024 revised McDonald criteria (Montalban et al., 2025),\n4. RMS with active disease as defined by Lublin et al. (2014) ,\n5. Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment,\n6. Disability status at enrollment with an EDSS score of 0 to 3.0 (inclusive),\n7. Planned initiation or initiation within the past 14 days with an approved injectable or oral DMT for MS as routine medical treatment:\n\n   * Ofatumumab: only naïve patients or patients previously treated with max. one DMT other than ofatumumab\n   * IFN-β1, GA, teriflunomide, DMF or DRF: only naïve patients\n\nCohort 1 Exclusion Criteria:\n\n1. Patients being treated outside of the approved label\n2. \\> 5 years since first symptom(s) (leading to MS diagnosis) at enrollment\n3. Previous therapy with any DMT for the treatment of MS prior to enrollment (except within the past 14 days with an approved injectable DMT for MS as routine medical treatment; see Inclusion criteria #7)\n4. Relapse prior to enrollment which has led to a severe deficit relevant to everyday life upon discretion of the investigator after exhaustion of the relapse therapy\n5. Poor recovery from the first two relapses prior to enrollment upon discretion of the investigator\n6. EDSS Functional System Score \"Pyramidal Functions\" ≥ 2 at enrollment\n7. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab\n\nCohort 2 Exclusion Criteria:\n\n1. Patients being treated outside of the approved label,\n2. \\>5 years since first symptom(s) (leading to MS diagnosis) at enrollment,\n3. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab,\n4. Patients being previously enrolled in cohort 1 are not eligible to be enrolled into cohort 2","100 Years",{"count":132,"type":21},"This is an observational, non-interventional, multicenter, open-label study in patients being treated with any approved injectable or selected oral DMT for RMS in Germany.\n\nProspective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to four years. Additionally, medical history of participants will be collected including disease duration, laboratory values, EDSS, MRI parameters and relapses.",[27],[27,30,215,216],"NIS","ofatumumab",{"date":218,"type":42},"2026-06-01",{"date":220,"type":42},"2022-05-10",{"date":222,"type":21},"2029-05-30",{"name":48,"class":49},129,{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":172},"100630113","phase-4-a-study-to-evaluate-the-efficacy-safety-pharmacokinetics-and-pharmacodynamics-of-ocrelizumab-in-participants-with-relapsing-multiple-sclerosis-and-primary-progressive-multiple-sclerosis-100630113","NCT07483450","A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis","A Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Chinese Patients With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis","Inclusion Criteria:\n\n* Diagnosis of RMS\u002FPPMS in accordance with the revised 2017 McDonald Criteria\n* EDSS score from 0-5.5 (RMS) or 3.0-6.5 (PPMS), inclusive, at screening and baseline\n* Documented MRI of brain with abnormalities consistent with MS before screening\n\nExclusion Criteria:\n\n* Diagnosis of PPMS or non-active secondary progressive multiple sclerosis (SPMS) (only for RMS cohort)\n* History of relapsing remitting multiple sclerosis (RRMS) or SPMS at screening (only for PPMS cohort)\n* Disease duration of more than 10 years in participants with an EDSS ≤ 2.0 at screening (only for RMS cohort)\n* History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)\n* Inability to complete an MRI scan or contraindication to Gd administration\n* Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines)\n* Known presence of other neurologic disorders if they could interfere with the diagnosis of MS or assessments of efficacy and\u002For safety during the study\n* Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study\n* Known history of human immunodeficiency virus (HIV) infection\n* Lack of peripheral venous access\n* Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab), unless the last infusion was at least 6 months prior to screening\n* Positive screening tests for hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV)","55 Years",{"count":234,"type":21},60,[236],"PHASE4","The main purpose of this study is to evaluate the efficacy of ocrelizumab in participants with relapsing multiple sclerosis (RMS) and to characterize the ocrelizumab pharmacodynamic (PD) profile in Chinese participants with primary progressive multiple sclerosis (PPMS).",[27,239],"Primary Progressive Multiple Sclerosis","2026-05-22",{"date":242,"type":42},"2026-05-27",{"date":244,"type":42},"2025-07-04",{"date":246,"type":21},"2027-04-23",{"name":171,"class":49},{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":232,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":258,"briefSummary":259,"conditions":260,"keywords":263,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":280},"100366158","phase-3-best-available-therapy-versus-autologous-hematopoietic-stem-cell-transplant-for-multiple-sclerosis-beat-ms-100366158","NCT04047628","Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)","A Multicenter Randomized Controlled Trial of Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (ITN077AI)","BEAT-MS","Inclusion Criteria:\n\n1. Age 18 to 55 years, inclusive, at the time of the screening Visit -2.\n2. Diagnosis of MS according to the 2017 McDonald Criteria139.\n3. EDSS ≤ 6.0 at the time of randomization (Day 0).\n4. T2 abnormalities on brain MRI that fulfill the 2017 McDonald MRI criteria for dissemination in space139. A detailed MRI report or MRI images must be available for review by the site neurology investigator.\n5. Highly active treatment-resistant relapsing MS, defined as ≥ 2 episodes of disease activity in the 36 months prior to the screening visit (Visit -2). The two disease activity episodes will be a clinical MS relapse or MRI evidence of MS disease activity and must meet all the criteria described below:\n\n   1. At least one episode of disease activity must occur following ≥ 1 month of treatment with one of the following: (i) an oral DMT approved by the FDA for the treatment of relapsing MS, or (ii) a monoclonal antibody approved by the FDA for the treatment of relapsing MS, or (iii) rituximab. Qualifying DMTs include: dimethyl fumarate, diroximel fumarate, monomethyl fumarate, teriflunomide, cladribine, daclizumab, ponesimod, siponimod, ozanimod, fingolimod, rituximab, ocrelizumab, natalizumab, alemtuzumab, ublituximab, and ofatumumab, and\n   2. At least one episode of disease activity must have occurred within the 12 months prior to the screening visit (Visit -2), and\n   3. At least one episode of disease activity must be a clinical MS relapse (see item c.i. below). The other episode(s) must occur at least one month before or after the onset of the clinical MS relapse, and must be either another clinical MS relapse or MRI evidence of disease activity (see item c.ii. below):\n\n   i. Clinical MS relapse must be confirmed by a neurologist's assessment and documented contemporaneously in the medical record. If the clinical MS relapse is not documented in the medical record, it must be approved by the study adjudication committee (see Section 3.5), and ii. MRI evidence of disease activity must include ≥ 1 unique active lesion on one or more brain or spinal cord MRIs. Detailed MRI reports or MRI images must be available for review by the site neurology investigator. A unique active lesion is defined as either of the following:\n\n1\\. A gadolinium-enhancing lesion, or 2. A new non-enhancing T2 lesion compared to a reference scan obtained not more than 36 months prior to the screening visit (Visit -2).\n\n6\\. Candidacy for treatment with at least one of the following high efficacy BAT DMTs: cladribine, natalizumab, alemtuzumab, ocrelizumab, ofatumumab, ublituximab and rituximab. Candidacy for treatment for each BAT DMT is defined as meeting all of the following:\n\n1. No prior disease activity episode, as defined in Inclusion Criterion #5, with the candidate BAT DMT, and\n2. No contraindication to the candidate BAT DMT, and\n3. No treatment with the candidate BAT DMT in the 12 months prior to screening.\n\n   7\\. Completion of COVID-19 vaccination series, according to the current Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommendations, ≥ 14 days prior to randomization (Day 0).\n\n   8\\. Positive for VZV antibodies, or completion of at least one dose of the varicella zoster glycoprotein E (gE) Shingrix vaccine at least 4 weeks prior to randomization (Day 0).\n\n   9\\. Insurance approval for MS treatment with at least one candidate BAT DMT (see Inclusion Criterion #6).\n\n   10\\. Ability to comply with study procedures and provide informed consent, in the opinion of the investigator.\n\n   11\\. Females of childbearing potential (defined in Section 5.4.3.1) and males with female partners of childbearing potential are required to adhere to the contraception provisions of Section 5.4.3.1.\n\n   12\\. For participants who use medicinal or recreational marijuana, willingness to substitute MARINOL® if randomized to AHSCT (Section 5.4.2.6).\n\nExclusion Criteria:\n\n1. Diagnosis of primary progressive MS according to the 2017 McDonald criteria.\n2. History of neuromyelitis optica spectrum disorder or MOG antibody disease.\n3. Prior treatment with an investigational agent within 3 months or 5 half-lives, whichever is longer. Agents authorized by the FDA for prevention or treatment of COVID-19 are not considered investigational.\n4. Either of the following within one month prior to randomization (Day 0):\n\n   1. Onset of acute MS relapse, or\n   2. Treatment with intravenous methylprednisolone 1000 mg\u002Fday for 3 days or equivalent.\n5. Initiation of any BAT DMT (see Section 5.2.1) between Visit -2 and randomization (Day 0).\n6. Brain MRI or cerebrospinal fluid (CSF) examination indicating a diagnosis of progressive multifocal leukoencephalopathy (PML).\n7. History of cytopenia consistent with the diagnosis of myelodysplastic syndrome (MDS).\n8. Presence of unexplained cytopenia, polycythemia, thrombocythemia or leukocytosis.\n9. History of sickle cell anemia or other hemoglobinopathy.\n10. Evidence of past or current hepatitis B or hepatitis C infection, including treated hepatitis B or hepatitis C. Hepatitis B surface antibody following hepatitis B immunization is not considered to be evidence of past infection.\n11. Presence or history of mild to severe cirrhosis.\n12. Hepatic disease with the presence of either of the following:\n\n    1. Total bilirubin ≥ 1.5 times the upper limit of normal (ULN) or total bilirubin ≥ 3.0 times the ULN in the presence of Gilbert's syndrome, or\n    2. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 2.0 times the ULN.\n13. Positive COVID-19 PCR test, or alternative nucleic acid amplification test (NAAT) per institutional standards, within 14 days prior to randomization (Day 0).\n14. Evidence of HIV infection.\n15. Positive QuantiFERON - TB Gold,TB Gold Plus, or T-SPOT®.TB test results. PPD tuberculin test may be substituted for QuantiFERON - TB Gold, TB Gold Plus, or T-SPOT®.TB test.\n16. Active viral, bacterial, endoparasitic, or opportunistic infections.\n17. Active invasive fungal infection.\n18. Hospitalization for treatment of infections or parenteral (IV or IM) antibacterials, antivirals, antifungals, or antiparasitic agents within the 30 days prior to randomization (Day 0) unless clearance is obtained from an Infectious Disease specialist.\n19. Receipt of live or live-attenuated vaccines within 6 weeks of randomization (Day 0).\n20. Presence or history of clinically significant cardiac disease including: a. Arrhythmia requiring treatment with any antiarrhythmia therapy, with the exception of low dose beta blocker for intermittent premature ventricular contractions.\n\n    b. Coronary artery disease with a documented diagnosis of either: i. Chronic exertional angina, or ii. Signs or symptoms of congestive heart failure. c. Evidence of heart valve disease, including any of the following: i. Moderate to severe valve stenosis or insufficiency, or ii. Symptomatic mitral valve prolapse, or iii. Presence of prosthetic mitral or aortic valve.\n21. Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n22. Impaired renal function defined as eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2, according to the CKD-EPI formula144.\n23. Forced expiratory volume in one second (FEV1) \\\u003C 70% predicted (no bronchodilator).\n24. Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for Hgb) \\\u003C 70% predicted.\n25. Poorly controlled diabetes mellitus, defined as HbA1c \\> 8%.\n26. History of malignancy, except adequately treated localized basal cell or squamous skin cancer, or carcinoma in situ of the cervix. Malignancies for which the participant is judged to be cured will be considered on an individual basis by the study adjudication committee (see Section 3.5).\n27. Presence or history of any moderate to severe rheumatologic autoimmune disease requiring treatment, including but not limited to the following: systemic lupus erythematous, systemic sclerosis, rheumatoid arthritis, Sjogren's syndrome, polymyositis, dermatomyositis, mixed connective tissue disease, polymyalgia rheumatica, polychondritis, sarcoidosis, vasculitis syndromes, or unspecified collagen vascular disease.\n28. Presence of active peptic ulcer disease, defined as endoscopic or radiologic diagnosis of gastric or duodenal ulcer.\n29. Prior history of AHSCT.\n30. Prior history of solid organ transplantation.\n31. Positive pregnancy test or breastfeeding.\n32. Failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.\n33. Psychiatric illness, mental deficiency, or cognitive dysfunction severe enough to interfere with compliance or informed consent.\n34. History of hypersensitivity to rabbit or Escherichia coli-derived proteins.\n35. Any metallic material or electronic device in the body, or other condition that precludes the participant from undergoing MRI with gadolinium administration, as determined by the site radiologist.\n36. Presence or history of ischemic cerebrovascular disorders, including but not limited to transient ischemic attack, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism, or cerebral hemorrhage.\n37. Presence or history of other neurological disorders, including but not limited to CNS or spinal cord tumor; metabolic or infectious cause of myelopathy; genetically-inherited progressive CNS disorder; CNS sarcoidosis; or systemic autoimmune disorders potentially causing progressive neurologic disease or affecting ability to perform the study assessments.\n38. Presence of any medical comorbidity that the investigator determines will significantly increase the risk of treatment mortality.\n39. Presence of any other concomitant medical condition that the investigator deems incompatible with trial participation.",{"count":257,"type":21},156,[24],"This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio.\n\nAll participants will be followed for 72 months after randomization (Day 0, Visit 0).",[27,261,262],"Relapsing Remitting Multiple Sclerosis","Secondary Progressive Multiple Sclerosis",[264,265,266,267,268,269],"Treatment-Resistant Relapsing Multiple Sclerosis (MS)","Autologous Hematopoietic Stem Cell Transplantation (AHSCT)","Autologous Peripheral Blood Stem Cells (PBMCs) Graft","Best Available Therapy (BAT)","Disease-Modifying Therapy (DMT)","BAT DMT","2026-01-02",{"date":272,"type":42},"2026-01-06",{"date":274,"type":42},"2019-12-19",{"date":276,"type":21},"2029-10",{"name":278,"class":279},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",22,{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":304},"100556768","phase-4-prospective-evaluation-of-sequencing-from-anticd-20-therapies-to-ozanimod-100556768","NCT06529406","Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod","Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod (COAST: CD20 and Ozanimod Sequencing Trial)","COAST","Inclusion Criteria:\n\n* Participants have been diagnosed with relapsing forms of MS and have had multiple sclerosis related symptoms at least 3 years prior to baseline visit\n* Male or female participants \\> or = to 18 years of age at the time of initiation of de-escalation\n* Participants do not have evidence of new inflammatory disease activity (no new T2\u002Fcontrast enhancing lesions, absence of relapses) for a minimum of two years prior to de-escalation\n* Participant is taking an anti-CD20 therapy as a DMT continuously for a minimum of two years (e.g., has received at least 3 courses of rituximab, ocrelizumab, ublituximab; 24 months of treatment with ofatumumab; or a combination of treatments whereby the patient has been deemed to be B-cell depleted for 2 years) prior to initiation of de-escalation\n* Participants received their last anti-CD20 infusion, including ocrelizumab subcutaneous injection, within 6-12 months or received their last ofatumumab injection within 30 -180 days from Day 1\n* Participants must provide written informed consent and be able to comply with the visit schedule and study related assessments\n* Participants must be able to undergo a brain MRI without anesthesia\n* Woman of Childbearing Potential must agree to practice a highly effective method of contraception throughout the study until completion and willing to follow pregnancy precautions.\n\nExclusion Criteria:\n\n* Any progression of neurological disability in the year prior to the screening visit that would be consistent with progressive MS\n* Participant has an EDSS \\>6.5\n* Participant has a history of other chronic neurological illnesses that might mimic MS with chronic or intermittent symptoms (i.e. ALS, myasthenia gravis, chronic neuropathy, etc.)\n* Participant is considering pregnancy in the short term, is pregnant, lactating or has a positive serum beta human chorionic gonadotropin (B-hCG) measured during screening.\n* Participant has any other significant medical or psychiatric illness, if uncontrolled, that could jeopardize a subject's health or put them at significant safety risk during the course of the study in the opinion of treating investigator. Examples: uncontrolled hypertension, uncontrolled diabetes, uncontrolled asthma, uncontrolled depression\n* Participant has a history of cancer within the last 5 years, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin or cervical dysplasia\u002Fcancer that has been excised and resolved)\n* Participant has a history in the last 6 months of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure\n* Participant has Mobitz type II second-degree or third degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker\n* Participant has severe untreated sleep apnea\n* Participant has a history of diabetes mellitus type 1, or uncontrolled diabetes mellitus type 2 with hemoglobin A1c (HbA1c) \\> 9%, or is a diabetic subject with significant comorbid conditions such as retinopathy or nephropathy, or a history of uveitis\n* Participant has a history or known presence of recurrent or chronic infection (e.g., hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV); recurrent urinary tract infections are allowed.\n* Any known or suspected active infection (excluding onychomycosis) at screening, including but not limited to a confirmed or suspected progressive multifocal leukoencephalopathy (PML). Known currently active tuberculosis (TB). History of incompletely treated Mycobacterium tuberculosis (TB) infection, as indicated by: Subject's medical records documenting incomplete treatment for Mycobacterium TB; Subject's self-reported history of incomplete treatment for Mycobacterium TB; Subjects with a history of TB who have undergone treatment accepted by the local health authorities (within 1 year from screening) may be eligible for study entry.\n\nExclusions related to Medications:\n\n* Concomitant use of a monoamine oxidase inhibitor\n* Use of systemic corticosteroids in the last 2 years, except for the use as a premedication for B-cell depleting treatment (Note: Use of inhaled or topical steroids; use of oral steroids for no greater than 14 days given for a non-MS condition are allowed)\n* Prior use of alemtuzumab, mitoxantrone, cyclophosphamide, methotrexate, cyclosporine, or any experimental MS treatment within 5 half-lives\n* Prior allergy to ozanimod\n\nExclusions related to Laboratory results:\n\n* Participant has IgG levels \\\u003C400 mg\u002FdL\n* Participant has neutrophils \\\u003C 1500\u002FμL (1.5 GI\u002FL)\n* Participant has an absolute white blood cell (WBC) count \\\u003C 3500\u002FμL (3.5 GI\u002FL)\n* Participant has an absolute lymphocyte count (ALC) \\\u003C 800 cells\u002FμL (0.80 GI\u002FL).\n* Participant has liver function impairment or persisting elevations of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) results \\> 3 x the upper limit of normal (ULN)",{"count":290,"type":21},100,[236],"A multi-center pilot study to evaluate safety and efficacy of ozanimod as de-escalation therapy in clinically stable MS patients previously treated with anti-CD20 therapy.",[27],"2025-09-12",{"date":296,"type":42},"2025-09-18",{"date":298,"type":42},"2024-07-29",{"date":300,"type":21},"2029-08-01",{"name":302,"class":303},"University of Colorado, Denver","OTHER",3,{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":130,"enrollmentInfo":312,"targetDuration":4,"studyType":22,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":4},"100603616","phase-4-a-phase-iv-study-of-dimethyl-fumarate-enteric-coated-capsules-for-relapsing-multiple-sclerosis-rms-100603616","NCT07138833","A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS)","A Multicenter, Open-label, Single Group, Phase 4 Study to Evaluate Dimethyl Fumarate Enteric-coated Capsules in Relapsing Multiple Sclerosis (RMS)","Inclusion Criteria:\n\n* Confirmed RMS per the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS)\n* At least one documented relapse within 12 months prior to screening; plus evidence of MS-consistent lesions on prior brain MRI or gadolinium-enhancing (GdE) lesions on an MRI performed within 6 weeks before screening\n* Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0 (inclusive) at screening\n\nExclusion Criteria:\n\n* History or current diagnosis of malignancy (except fully resected basal cell carcinoma), or uncontrolled severe diseases of major organ systems (e.g., cardiac, renal, hepatic, neurological \\[excluding multiple sclerosis\\]) that, in the investigator's assessment, pose a significant risk to the subject or could confound study results.\n* Protocol-defined multiple sclerosis (MS) relapse within 30 days prior to screening, or failure to achieve clinical stability from a prior relapse.\n* History of suicidal behavior within 5 years prior to screening. Suicidal ideation (indicated by a \"Yes\" response to Item 4 or 5 on the C-SSRS) within 6 months prior to screening.Subjects with a history of suicidal behavior occurring \\>5 years prior to screening require investigator assessment of eligibility.",{"count":313,"type":21},50,[236],"The goal of this clinical trial is to evaluate the efficacy and safety\\] in \\[subjects diagnosed with RMS according to the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS).\n\nThe main questions it aims to answer are:\n\n\\[Question 1\\] The efficacy of dimethyl fumarate enteric-coated capsules in the treatment of RMS.\n\n\\[Question 2\\] The safety of dimethyl fumarate enteric-coated capsules in the treatment of RMS.\n\nParticipants will:\n\nEligible 50 RMS patients will orally take dimethyl fumarate enteric-coated capsules during treatment, with an initial dose of 120 mg twice daily for 7 days, followed by a maintenance dose of 240 mg twice daily for 48 weeks.\n\nThe annualized relapse rate (ARR) at Week 48 will be observed.",[27],"2025-08-17",{"date":319,"type":42},"2025-08-24",{"date":321,"type":21},"2025-09",{"date":323,"type":21},"2028-08",{"name":325,"class":49},"Qilu Pharmaceutical (Hainan) Co., Ltd.",{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":332,"enrollmentInfo":333,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":335,"conditions":336,"keywords":337,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":348},"100501494","ofatumumab-in-portuguese-multiple-sclerosis-patients---an-observational-study-100501494","NCT05809986","Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study","Inclusion Criteria:\n\nTo participate in the study, all the following inclusion criteria must be met:\n\n* Patients aged 18 years or older\n* Written informed consent obtained before participating in the study.\n* Patient is willing and able to complete the assessments, including PRO questionnaires, as outlined in this study.\n* Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab.\n* Treatment with Ofatumumab is in accordance with the Portuguese indication of Kesimpta® (i.e., treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features).\n* Patients that have initiated Ofatumumab up to 12 M prior inclusion in the study OR Patients that are initiating Ofatumumab at the moment of study inclusion.\n\nExclusion Criteria:\n\nTo participate in the study, none of the following exclusion criteria must be met:\n\n* Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.\n* Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone, Rituximab and Alemtuzumab) in both cohorts prior to the initiation of Ofatumumab.","99 Years",{"count":334,"type":21},174,"This non-interventional study will compare the effect of Ofatumumab treatment between patients that began Ofatumumab within the 3 years after Multiple Sclerosis diagnosis and patients that began Ofatumumab with more than 3 years of Multiple Sclerosis diagnosis in a real-world setting in Portugal.",[27],[27,30,338,215,339],"Ofatumumab","Portugal","2025-01-12",{"date":342,"type":42},"2025-01-14",{"date":344,"type":42},"2023-11-27",{"date":346,"type":21},"2026-09-15",{"name":48,"class":49},10]