Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab

Launched by TG THERAPEUTICS, INC. · May 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a modified treatment approach using a drug called ublituximab for people with relapsing multiple sclerosis (RMS). The main goal is to see how effective this new regimen is in reducing brain lesions that can be seen on MRI scans. The trial is currently looking for participants aged 18 to 65 who have been diagnosed with RMS and are either new to treatment or have stopped their previous treatment for a while. Participants should also be in stable health for at least 30 days before starting the study.

If you join this trial, you will receive the modified ublituximab treatment and will be monitored for any changes in your condition. It’s important to note that there are certain health conditions that might prevent someone from participating, such as a history of specific serious infections or certain other health issues. If you have questions about your eligibility or what to expect during the trial, the study team will provide detailed information and support throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of RMS (2017 Revised McDonald criteria).
• * Participants must meet one of the following prior treatment definitions:
• • 1. Participants naïve to treatment.
• • 2. Participants previously treated with a disease modifying therapy (DMT) who have discontinued treatment prior to consent and meet the washout requirements.
• • Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
• • Neurologically stable for \> 30 days prior to first dose of ublituximab.
• • Female participants of childbearing potential must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 6 months after the last dose of ublituximab.
• Exclusion Criteria:
• • History of any serious 3 Infusion Related Reaction (IRR) on prior anti-CD20 therapy.
• • Primary-progressive multiple sclerosis (PPMS) or inactive Secondary Progressive MS (SPMS).
• • 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.).
• • 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).
• • Previous serious opportunistic or atypical infection.
• • Evidence of chronic active or history of hepatitis B virus (HBV) infection 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 ribonucleic acid (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 varicella-zoster virus or measles) within 4 weeks prior to first study drug administration.
• • Participants requiring treatment with intravenous immune globulin (IVIG) for decreased immunoglobulins within the 12 months prior to W1D1.
• • Any active malignancies other than adequately treated basal, squamous cell or in situ carcinoma.
• • Participants who have ever received ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab (including for non-MS indications).
• • Note: Other Inclusion/Exclusion criteria may apply.