Evaluation of intravenous or subcutaneous administration of ublituximab in patients with multiple sclerosis
- Conditions
- Relapsing multiple sclerosisMedDRA version: 21.0Level: PTClassification code: 10080700Term: Relapsing multiple sclerosis Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2023-509555-13-00
- Lead Sponsor
- Tg Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
18-65 years old, Diagnosis of RMS (2017 Revised McDonald criteria), Expanded Disability Status Scale (EDSS) score = 5.5 at screening, 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
Primary-progressive MS (PPMS) or inactive Secondary Progressive MS (SPMS), Treatment with any investigational agent within 5 half-lives of the investigational drug, or treatment with any experimental procedure for MS (e.g., treatment for chronic cerebrospinal venous insufficiency), History of life-threatening injection/infusion related reaction (IRR), hypersensitivity, or anaphylactic reaction with anti-CD20 therapy, components of ublituximab solution or pre-treatment medications, 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), History of serious opportunistic or atypical infections, including human immunodeficiency virus (HIV), History of active hepatitis B virus (HBV) 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 RNA, History or evidence (clinical, radiological, or biomarker) of suspected or confirmed progressive multifocal leukoencephalopathy (PML), Receipt of any live or live-attenuated vaccines (including vaccines for varicellazoster virus or measles) within 4 weeks prior to first study drug administration, Any severe or uncontrolled medical condition that could affect the participant’s ability to participate, Females who are pregnant or nursing, History of cancer except: - If considered likely to be cured (with supporting documentation from the treating oncologist if possible), - Is not being actively treated with anti-cancer therapy or radiotherapy and, in the opinion of the Investigator, is not likely to require treatment in the ensuing 3 years, - Considered to have low probability of recurrence (with supporting documentation from the treating oncologist if possible), - Adequately treated and/or resolved basal or in situ squamous carcinomas of the skin are permitted, Unwillingness or inability to comply with study and/or follow-up procedures outlined in the protocol., 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.)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method