Clinical trial study design

This promotional website is intended for UK healthcare professionals.

Briumvi® (ublituximab) is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.¹

BRIUMVI®

Study design

BRIUMVI® was evaluated in two identically designed phase 3, global, randomised studies: the ULTIMATE I and II clinical studies^1,2

Inclusion criteria:

Age 18 to 55
relapsing multiple sclerosis
expanded Disability Status Scale score of 0-5.5
either two or more relapses in the previous 2 years, or one relapse and/or at least one Gd+ T1 lesion in the year before screening.

Participants reported new or worsening neurological symptoms within 48 hours of symptom onset, and were then assessed for protocol-defined relapse.

Patients also underwent magnetic resonance imaging scans at Weeks 12, 24, 48, and 96.

Primary endpoint Annualised relapse rate at 96 weeks

Selected secondary endpoints

Number of T1 Gd+ lesions by Week 96.
Number of new or enlarging T2 hyperintense lesions by Week 96.
Confirmed disability progression at 12 weeks.

Patients in both trials had comparable baseline demographics^1,2

Notes

*The mITT population consists of all subjects in the ITT population who received at least one dose of the study medication and had at least one baseline and post-baseline efficacy assesment.

BRIUMVI® (ublituximab) 150 mg concentrate for solution for infusion

BRIUMVI® (ublituximab) is indicated for the treatment of adult patients with relapsing forms of MS (RMS) with active disease defined by clinical or imaging features.¹

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Reporting forms and information can be found at: https://yellowcard.mhra.gov.uk/. Adverse events should also be reported to Neuraxpharm by email: info-uk@neuraxpharm.com.

NXUK/0225/02 Date of preparation: October 2025

References
¹BRIUMVI®. Summary of Product Characteristics.²Steinman L, Fox E, Hartung H-P, et al. . N Engl J Med. 2022;387(8):704-714 and Supplementary Appendix. doi:10.1056/NEJMoa2201904.

Abbreviations:
DMT, disease-modifying therapy; EDRSS, Expanded Disability Status Scale; Gd+, gadolinium-enhancing; mITT, modified intention-to-treat; RMS, relapsing forms of multiple sclerosis; SD, standard deviation.