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Clinical Trial Summary

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


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04130997
Study type Interventional
Source TG Therapeutics, Inc.
Contact
Status Active, not recruiting
Phase Phase 3
Start date November 18, 2019
Completion date April 1, 2027

See also
  Status Clinical Trial Phase
Completed NCT03277261 - Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 ) Phase 3
Completed NCT02921035 - Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)
Terminated NCT04878211 - A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab Phase 4
Recruiting NCT04086225 - Effects of Cladribine Tablets on the Pharmacokinetics of Microgynon® Phase 1
Completed NCT03745144 - Effects of Cladribine Tablets on the PK of Microgynon® Phase 1
Active, not recruiting NCT04667949 - Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients Phase 4
Completed NCT03277248 - Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) Phase 3