Active — Not RecruitingPhase 3

An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis

United States1,100 participantsStarted 2019-11-18

Plain-language summary

The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).

Who can participate

Age range18 Years

SexALL

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Inclusion 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

Exclusion criteria

✕. 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
✕. Active infection
✕. Ongoing pregnancy (female participants)
✕. 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

What they're measuring

Annualized Relapse Rate (ARR)

Timeframe: Up to Week 336

Trial details

NCT IDNCT04130997

SponsorTG Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2032-05-31

View on ClinicalTrials.gov More Relapsing Multiple Sclerosis (RMS) trials