[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631683":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":36,"centralContacts":37,"locations":36,"responsibleParty":43,"collaborators":36,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":36,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":36,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":36,"overallStatus":64,"whyStopped":36,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":36},{"fullName":5,"class":6},"TG Therapeutics, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Ublituximab SC","EXPERIMENTAL","Participants will receive ublituximab SC, using a syringe at one of three different sites of administration.",[13],"Drug: Ublituximab",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 2: Ublituximab SC","Participants will be randomized to receive ublituximab SC using either the AI device or a syringe.",[13,18],"Device: AI Device",[20,27,31],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Ublituximab","Administered as an SC injection by a syringe.",[9,15],[26],"TG-1101",{"type":21,"name":22,"description":28,"armGroupLabels":29,"otherNames":30},"Administered as an SC injection by AI device.",[15],[26],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DEVICE","AI Device","Ublituximab will be administered as an SC injection by AI device.",[15],null,[38],{"name":39,"role":40,"phone":41,"phoneExt":36,"email":42},"TG Therapeutics Clinical Support Team","CONTACT","1-877-575-8489","clinicalsupport@tgtxinc.com",{"type":44,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100631683","phase-2-a-study-to-evaluate-pharmacokinetics-pk-and-safety-of-subcutaneous-sc-ublituximab-administered-at-various-injection-sites-and-relative-bioavailability-via-autoinjector-ai-versus-syringe-subcutaneously-in-participants-with-multiple-sclerosis-ms-100631683",false,"NCT07503873","A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)","A Phase 2, Multicenter, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector Device Versus Syringe in Patients With Multiple Sclerosis","Inclusion Criteria:\n\n1. Diagnosis of relapsing multiple sclerosis (RMS) (2017 Revised McDonald criteria).\n2. Expanded Disability Status Scale (EDSS) score less than or equal to (≤) 5.5 at screening.\n3. Neurologically stable for more than (\\>) 30 days prior to screening and Day 1.\n4. Female participants of childbearing potential must consent to use an effective method of contraception from consent and for 6 months after the last dose of ublituximab.\n\nExclusion Criteria:\n\n1. Primary-progressive multiple sclerosis (PPMS) or inactive secondary progressive multiple sclerosis (SPMS).\n2. Active chronic disease of the immune system other than MS or immunodeficiency syndrome.\n3. Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.\n4. Participants who received any approved therapy to treat MS within 5 half-lives of the medication prior to screening.\n5. Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening.\n6. Females who are pregnant or nursing.\n\nNote: Other protocol-specified Inclusion\u002FExclusion criteria may apply.","ALL","18 Years","65 Years",{"count":56,"type":57},350,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC with an AI device versus syringe.",[63],"Multiple Sclerosis","NOT_YET_RECRUITING","2026-03-26",{"date":67,"type":68},"2026-03-31","ACTUAL",{"date":70,"type":57},"2026-03-21",{"date":72,"type":57},"2029-05-30",{"name":5,"class":6}]