An Extension of the TG1101-RMS201 Trial

TG Therapeutics

Status and phase: Completed; Phase 2

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Biological: Ublituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03381170

TG1101-RMS201E

Details and patient eligibility

About

This study evaluates the long term use of a single agent ublituximab, a novel monoclonal antibody, in patients with relapsing forms of multiple sclerosis

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects currently enrolled in TG1101-RMS201 trial
• Subjects who have completed three infusions of ublituximab (at Day 1, Day 15, and Week24, as specified in the TG1101-RMS201 protocol) and have completed the scheduled assessments up to the final 48-week visit

Exclusion criteria

• Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101- RMS201 study during the 48-week evaluation period
• Subjects who have started any other immunomodulating or disease modifying therapy after completion of the TG1101-RMS201 trial
• Pregnant or nursing mothers

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Ublituximab

Experimental group

Description:

Ublituximab IV infusions on Weeks 1E, 24E, 48E, 72E and (6E

Treatment:

Biological: Ublituximab