An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis

Korábbi kezelés

• Participants who discontinued ublituximab treatment or withdrew consent from the TG1101-RMS301 or TG1101-RMS302 study during the 96-week evaluation period or prior to completing the final Week 208 visit of the TG1101-RMS201E study
• Participants who have had a confirmed multiple sclerosis (MS) relapse within the past 30 days prior to Week 1 Day 1 (W1D1). Following a relapse, participants must be neurologically stable for at least 30 days prior to screening or W1D1 of the OLE

Más betegség

• Active infection
• Participants who have started any disease modifying therapy (DMT), stem cell transplantation, or participation in any other interventional clinical trial after completion of the 96-week visit in the TG1101-RMS301, TG1101-RMS302, or after completing the final Week 208 visit of the TG1101-RMS201E study
• Participants with unstable disease activity
• Presence of malignancy, except for surgically excised basal or squamous cell skin lesions

Laborértékek

• Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as:
  • Absolute neutrophil count < 1.5 x 10e3/µL
  • Hematocrit < 24%
  • Platelet count < 150,000 cell/mm\^3
  • Hypogammaglobulinemia immunoglobulin G (IgG) < 4.0g/L

Egyéb

• Participants who meet any of the following exclusion criteria are not to be enrolled to this study:
• Ongoing pregnancy (female participants)
• Vaccination with live virus within 2 months of randomization

• Participants must meet the following criteria:
• Complete the 96-week double-blind TG1101-RMS301 (NCT03277261) or TG1101-RMS302 (NCT03277248) study or complete the final Week 208 visit of the TG1101-RMS201E (NCT03381170) study
• Investigator believes may benefit from treatment with ublituximab
• Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol
• Female participants of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 20 weeks after the last dose of ublituximab