Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )

Summary

This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV placebo.

Timeline

Start

2017-09-19

Primary completion

2020-07-23

Completion

2020-11-06

Outcome

Met primary endpoint

registry analysis (superiority test); Ublituximab + Oral Placebo vs Teriflunomide + IV Placebo; p <0.0001; Rate Ratio (Ublituximab/Teriflunomide) 0.406 (95% CI 0.268 to 0.615) NCT03277261 ↗

Publications

• Robertson D, Alvarez E, Steinman L, Hartung HP, Qian P, Selmaj K, Wray S, Wynn D, Fox EJ, Mok K, Miskin HP, Xu Y, Garner CA, Cree BAC. Disease outcomes with ublituximab in treatment-naive participants: subpopulation analyses of the phase 3 ULTIMATE I and II studies in participants with relapsing multiple sclerosis. Front Immunol. 2026 May 29;17:1771848. doi: 10.3389/fimmu.2026.1771848. eCollection 2026.
• Hartung HP, Robertson D, Steinman L, Arnold DL, Qian P, Wray S, Fox E, Garner CA, Xu Y, Mok K, Gocke A, Cree BAC, Alvarez E. Efficacy of Ublituximab in People with Highly Active Relapsing Multiple Sclerosis. Neurol Ther. 2026 Jun;15(3):1081-1097. doi: 10.1007/s40120-026-00904-4. Epub 2026 Mar 6.
• Alvarez E, Steinman L, Fox EJ, Hartung HP, Qian P, Wray S, Robertson D, Selmaj K, Wynn D, Mok K, Xu Y, Bodhinathan K, Miskin HP, Cree BAC. Improvements in no evidence of disease activity with ublituximab vs. teriflunomide in the ULTIMATE phase 3 studies in relapsing multiple sclerosis. Front Neurol. 2024 Oct 24;15:1473284. doi: 10.3389/fneur.2024.1473284. eCollection 2024.
• Steinman L, Fox E, Hartung HP, Alvarez E, Qian P, Wray S, Robertson D, Huang D, Selmaj K, Wynn D, Cutter G, Mok K, Hsu Y, Xu Y, Weiss MS, Bosco JA, Power SA, Lee L, Miskin HP, Cree BAC; ULTIMATE I and ULTIMATE II Investigators. Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis. N Engl J Med. 2022 Aug 25;387(8):704-714. doi: 10.1056/NEJMoa2201904.

Drugs

Indications