Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT07211633
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
Sponsor:
Organization:
Raw JSON
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Diagnosis of RMS (2017 Revised McDonald criteria).\n2. Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.\n3. Neurologically stable for \\> 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 previously received anti-CD20 therapy at any time; any approved therapy to treat MS within 5 half-lives of the medication prior to screening.\n\nNote: Other Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT07211633', 'briefTitle': 'A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'TG Therapeutics, Inc.'}, 'officialTitle': 'A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab Versus Intravenous Ublituximab in Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'TG1101-RMS-SC301'}, 'secondaryIdInfos': [{'id': '2025-521127-73-00', 'type': 'OTHER', 'domain': 'EU CT Number'}]}, 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