UBLITUXIMAB for Multiple sclerosis|Relapsing multiple sclerosis

Inclusion criteria

• {"criterion_text":"-18-65 years old\n-Diagnosis of RMS (2017 Revised McDonald criteria, see Section 17.1) and documented evidence of either a. ≥ 2 relapses in prior 2 years or 1 relapse in the one year prior to screening, and/or b. ≥1 Gd enhancing lesion in the year prior to screening\n-Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening\n-Neurologically stable for > 30 days prior to Screening and Day 1\n-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"}

Exclusion criteria

• {"criterion_text":"-Primary-progressive MS (PPMS) or inactive Secondary Progressive MS (SPMS)\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 (Day 1)\n-Any severe or uncontrolled medical condition that could affect the participant’s ability to participate\n-Females who are pregnant or nursing\n-History of any malignancy/cancer except basal cell or in situ squamous cell carcinomas of the skin that have been definitively treated\n-Unwillingness or inability to comply with study and/or follow-up procedures outlined in the protocol\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-Participants with significantly impaired organ function as evidenced by the laboratory-based eligibility criteria\n-Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening\n-History of life-threatening injection/infusion related reaction (IRR), hypersensitivity, or anaphylactic reaction with any component of the ublituximab solution, protocol required pre-treatment medications, or protocol required procedure medications (including magnetic resonance imaging [MRI] contrast)\n-Active infection or known history of clinically significant recurrent infection\n-History of serious opportunistic or atypical infections, including human immunodeficiency virus (HIV) and tuberculosis\n-History of hepatitis B virus (HBV) infection as evidenced by a detectable hepatitis B surface antigen (HBsAg) or positive hepatitis B core antibody (HBcAb)\n-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)"}

Primary endpoints

• {"endpoint_text":"-Incidence of treatment emergent adverse events (TEAE)","definition_or_measurement_approach":"Measured as incidence of treatment-emergent adverse events (TEAEs). No additional definition provided in source."}

Secondary endpoints

• {"endpoint_text":"-Incidence of TEAE","definition_or_measurement_approach":"Measured as incidence of TEAEs (no further definition provided)."}

Poland

Earliest CTIS Part Ii Submission Date

11-03-2026

Latest Decision Or Authorization Date

03-04-2026

Processing Time Days

23

Number Of Sites

10

Number Of Participants

120

Primary sponsor

Full Name

Tg Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Psi Cro AG

Responsibilities

CRO for countries outside the EU

Third parties

• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"United Biosource LLC","duties_or_roles":"sponsorDuties codes: 8","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"CluePoints","duties_or_roles":"Risk-Based Monitoring (code 15)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Charles River Laboratories International Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Bulgaria","full_name":"Psi Pharma Support EOOD","duties_or_roles":"COA questionnaires storage and distribution (code 15)","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Neurostatus-UHB AG","duties_or_roles":"EDSS (code 15)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"Clinigen Clinical Supplies Management","duties_or_roles":"IMP importation; other (codes 14, 15)","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Brillance Sp. z o.o.","duties_or_roles":"Multiple roles including management of compensation/reimbursement for patients (codes: 1,12,15(value: Management of compensation/reimbursement for patients),2,5)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Clinigen Clinical Supplies Management GmbH","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"CRO for countries outside the EU (code 15)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}