protocolSection identificationModule nctId: NCT06292923, orgStudyIdInfo id: TILS-021, briefTitle: A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Tiziana Life Sciences LTD, class: INDUSTRY, descriptionModule briefSummary: Foralumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases.The goal of this Phase 2a, randomized, double-blind placebo-controlled, multicenter dose-ranging study is to evaluate the use of nasal foralumab in patients with non-active secondary progressive multiple sclerosis (SPMS).The primary objectives that this study aims to answer are:1. To determine the safety and tolerability of 50 μg/dose and 100 μg/dose of foralumab nasal compared to placebo2. To investigate the effect of foralumab relative to placebo on the change from baseline \[18F\]PBR06-positron emission tomography (PET) scans for microglial activation, after 12 weeks (3) months of study treatment., conditionsModule conditions: Secondary Progressive Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The treating physician, study staff, and patients will be blinded to treatment. The research pharmacy at each site will have the treatment code assignments., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Foralumab, interventions name: Placebo, outcomesModule primaryOutcomes measure: The number of patients with adverse event (AE) reports., primaryOutcomes measure: Changes in the Total Nasal Symptom Score (TNSS)., primaryOutcomes measure: Change from baseline for [18F]PBR06-positron emission tomography (PET) scans for microglial activation after 12 weeks (3 months) of study treatment., secondaryOutcomes measure: Changes in the Expanded Disability Status Scale (EDSS)., secondaryOutcomes measure: Changes in the Multiple Sclerosis Functional Composite-4 (MSFC-4)., secondaryOutcomes measure: Changes in the Modified Fatigue Impact Scale (MFIS)., otherOutcomes measure: Changes in the mean number of gadolinium-enhancing lesions per T1-weighted MRI scan, as measured by 3T MRI., otherOutcomes measure: Changes in percent brain volume change by 3T MRI analysis pipeline between the Screening Visit (Baseline) and after 3 months of treatment, as measured by 3T MRI., otherOutcomes measure: Paramagnetic rim lesions by quantitative susceptibility mapping sequences on MRI, as measured by 3T MRI (if center is able)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Niveditha Gopalakrishnan, role: CONTACT, phone: 617-732-5588, email: foralumab@mgb.org, contacts name: Tanuja Chitnis, M.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False