NCT04130997

An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,100 (estimated)
• Sponsor: TG Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

TG1101-RMS303 is an open-label, single-arm extension study designed to evaluate long-term safety and efficacy of ublituximab in participants with RMS. Participants who complete the 96-week, double-blind treatment period of TG1101-RMS301 (RMS301 \[NCT03277261\]) or TG1101-RMS302 (RMS302 \[NCT03277248\]) are eligible for participation in this Open Label Extension (OLE) study. Participants may also be eligible for TG1101-RMS303 if they have completed Week 208 of TG1101-RMS201E (RMS201E \[NCT03381170\]) (United States of America \[USA\] participants only).

Conditions

• Relapsing Multiple Sclerosis (RMS)

Interventions

Type	Name	Description
BIOLOGICAL	Ublituximab	Ublituximab (TG-1101) is a recombinant chimeric monoclonal antibody targeting CD20, available as a 25 mg/mL concentrate for intravenous use, supplied by TG Therapeutics, Inc.

Timeline

• Start date: 2019-11-18
• Primary completion: 2032-05-31
• Completion: 2032-05-31
• First posted: 2019-10-18
• Last updated: 2026-04-08

Locations

86 sites across 8 countries: United States, Belarus, Croatia, Georgia, Poland, Russia, Serbia, Ukraine

Regulatory

• FDA-regulated drug study