An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis

Prior treatment

• Subjects 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.
• Subjects who have had a confirmed MS relapse within the past 30 days prior to Week 1 Day 1 (W1D1). Following a relapse, subjects must be neurologically stable for at least 30 days prior to screening or W1D1 of the OLE.

Other illness

• Active infection
• Subjects 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 the final Week 208 visit of the TG1101- RMS201E study.
• Subjects with unstable disease activity
• Presence of malignancy, except for surgically excised basal or squamous cell skin lesions

Lab values

• Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as: a. Absolute neutrophil count < 1.5 x 10e3/μL b. Hematocrit < 24% c. Platelet count < 150,000 cell/mm3 d. Hypogammaglobulinemia

Other

• Ongoing pregnancy (female subjects)
• Vaccination with live virus within 2 months of randomization

• Complete the 96-week double-blind TG1101-RMS301 or TG1101-RMS302 study OR complete the final Week 208 visit of the TG1101-RMS201E 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 subjects of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception