An Extension of the TG1101-RMS201 Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2023
• Main ID: NCT03381170
• Date of registration: 18/12/2017
• Prospective Registration: No
• Primary sponsor: TG Therapeutics, Inc.
• Public title: An Extension of the TG1101-RMS201 Trial
• Scientific title: An Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple Sclerosis
• Date of first enrolment: June 1, 2017
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03381170
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis

Intervention(s)

Biological: Ublituximab

Primary Outcome(s)

Number of participants with treatment-related events as assessed by CTCAE V4.0 [Time Frame: 96 weeks on therapy]

Secondary Outcome(s)

Evaluate the % of participants with relapses [Time Frame: up to 96 Weeks]

Secondary ID(s)

TG1101-RMS201E

Source(s) of Monetary Support

Please refer to primary and secondary sponsors