Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension Study.

ABSTRACT:

Importance

In the 2-year Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (ULTIMATE) I and II randomized clinical studies, disease activity was significantly reduced with ublituximab vs teriflunomide in participants with relapsing multiple sclerosis (RMS).

Objective

To evaluate long-term ublituximab clinical efficacy and safety.

Design, setting, and participants

The 2-year, multicenter, randomized, active-controlled, double-blind period (DBP) of the ULTIMATE I and II phase 3 studies occurred September 2017 to November 2020. Enrollment in the ongoing ULTIMATE open-label extension (OLE) study began November 2019; data cutoff for this analysis was January 1, 2024.

Intervention

ULTIMATE OLE participan

SUBMITTER: Cree BAC 

PROVIDER: S-EPMC12910456 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature