NCT07225361

Brief Summary

In this prospective, open-label, single-arm, single-institution trial, the investigators will accomplish the following two aims:

  1. 1.study the safety and tolerability of Ublituximab (Briumvi) twice annually in participants with early MS over a treatment observation period of \~12 months.
  2. 2.study the pre- and post-treatment change in plasma neurofilament light chain, tested at baseline pre-Ublituximab treatment, and q24 weeks for 96 weeks post Ublituximab treatment initiation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 multiple-sclerosis

Timeline
38mo left

Started Nov 2025

Typical duration for phase_4 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Nov 2025Aug 2029

First Submitted

Initial submission to the registry

October 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 6, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

November 28, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2029

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3.3 years

First QC Date

October 29, 2025

Last Update Submit

March 16, 2026

Conditions

Multiple SclerosisMultiple Sclerosis (MS) - Relapsing-remitting

Keywords

UblituximabBriumviMultiple SclerosisRelapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Change in plasma neurofilament light chain

    Change in plasma neurofilament light chain concentration from baseline (pre-Ublituximab IV) to follow-up visits while on treatment longitudinally.

    Time Frame: Baseline (pre-treatment), and at 24, 48, 72, and 96 weeks post-treatment initiation

Secondary Outcomes (1)

  • Safety of Ublituximab

    From baseline through study completion, up to 96 weeks

Other Outcomes (1)

  • Tolerability of Ublituximab

    From baseline through study completion, up to 96 weeks.

Study Arms (1)

Participants with Relapsing Multiple Sclerosis

EXPERIMENTAL

Participants with Relapsing Multiple Sclerosis will be treated with Ublituximab for the duration of the study.

Drug: Ublituximab

Interventions

UblituximabDRUG

Currently, many care plans may defer initiating high-efficacy DMTs, such as Ublituximab, for patients who previously would have been previously considered to have clinically isolated syndrome or not definite MS because of safety concerns. Recent label updates including a case of progressive multifocal leukoencephalopathy and transaminase elevations may exacerbate this worry. However, emerging evidence suggests treatment at the earliest timepoint has important, favourable impacts on long-term MS outcomes, far outweighing safety risks. Data in this early-diagnosis MS population are however lacking, and robust safety and tolerability data, underscored by biomarkers that are relevant to people with early MS, will guide prescribers in clinical decision making and likely encourage early MS treatment adoption.

Also known as: Briumvi
Participants with Relapsing Multiple Sclerosis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet 2024 Criteria for Multiple Sclerosis (Montalban et al.) as confirmed by a neurologist; Includes dissemination in space in two of five topographies (with optic nerve included) and/or biomarker evidence such as positive cerebrospinal fluid oligoclonal bands, elevated kappa free light chains, at least six central vein lesions, or at least one paramagnetic rim lesion;
  • Adult age 18-70 years,
  • EDSS \<2.5,
  • Able to provide individual informed consent,
  • MRI brain available to confirm the diagnosis of MS with fewer than 10 demyelinating lesions,
  • Diagnosis of MS within the past \<5 years,
  • Planning to start Ublituximab for the treatment of relapsing MS,

You may not qualify if:

  • Prior exposure to Mavenclad, Lemtrada, Cyclophosphamide, stem cell transplant or related bone marrow suppressive treatment,
  • Prior exposure to other B-cell depleting agent including Ocrelizumab, Rituximab, Ofatumumab, and Inebilizumab.
  • Current clinical trial participant,
  • Unable to speak a language for which translation can be found in the hospital system,
  • Unclear documentation of MS diagnosis or prior or current MS treatment,
  • Recent major surgical procedure in the past 6 months,
  • History of life-threatening infusion reaction on Ublituximab or prior anti-CD20 therapy
  • Active hepatitis B virus (HBV) confirmed by positive results for Hepatitis B surface antigen (HBsAg) and anti-HBV tests.
  • Receipt of any live of live-attenuated vaccines within 4 weeks prior to first drug product administration
  • Moribund status,
  • Unable to provide consent voluntarily due to reasons of capacity or other reasons (e.g. incarcerated, etc.),
  • Unwilling to undergo blood draws,
  • Unable to access Ublituximab through clinical coverage throughout the full 96-week treatment study period,
  • Unable to complete the study activities for any reason as deemed by the study investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (8)

  • Vermunt L, Otte M, Verberk IMW, Killestein J, Lemstra AW, van der Flier WM, Pijnenburg YAL, Vijverberg EGB, Bouwman FH, Gravesteijn G, van de Berg WDJ, Scheltens P, van Harten AC, Willemse EAJ, Teunissen CE. Age- and disease-specific reference values for neurofilament light presented in an online interactive support interface. Ann Clin Transl Neurol. 2022 Nov;9(11):1832-1837. doi: 10.1002/acn3.51676. Epub 2022 Oct 5.

    PMID: 36196979BACKGROUND

  • Canto E, Barro C, Zhao C, Caillier SJ, Michalak Z, Bove R, Tomic D, Santaniello A, Haring DA, Hollenbach J, Henry RG, Cree BAC, Kappos L, Leppert D, Hauser SL, Benkert P, Oksenberg JR, Kuhle J. Association Between Serum Neurofilament Light Chain Levels and Long-term Disease Course Among Patients With Multiple Sclerosis Followed up for 12 Years. JAMA Neurol. 2019 Nov 1;76(11):1359-1366. doi: 10.1001/jamaneurol.2019.2137.

    PMID: 31403661BACKGROUND

  • Fitzgerald KC, Sotirchos ES, Smith MD, Lord HN, DuVal A, Mowry EM, Calabresi PA. Contributors to Serum NfL Levels in People without Neurologic Disease. Ann Neurol. 2022 Oct;92(4):688-698. doi: 10.1002/ana.26446. Epub 2022 Jul 13.

    PMID: 35730070BACKGROUND

  • Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.

    PMID: 6685237BACKGROUND

  • Sotirchos ES, Fitzgerald KC, Singh CM, Smith MD, Reyes-Mantilla M, Hersh CM, Hyland MH, Canissario R, Simmons SB, Arrambide G, Montalban X, Comabella M, Naismith RT, Qiao M, Krupp LB, Nicholas JA, Akgun K, Ziemssen T, Rudick R, Fisher E, Bermel RA, Mowry EM, Calabresi PA. Associations of sNfL with clinico-radiological measures in a large MS population. Ann Clin Transl Neurol. 2023 Jan;10(1):84-97. doi: 10.1002/acn3.51704. Epub 2022 Nov 25.

    PMID: 36427295BACKGROUND

  • Freedman MS, Abdelhak A, Bhutani MK, Freeman J, Gnanapavan S, Hussain S, Madiraju S, Paul F. The role of serum neurofilament light (sNfL) as a biomarker in multiple sclerosis: insights from a systematic review. J Neurol. 2025 May 15;272(6):400. doi: 10.1007/s00415-025-13093-1.

    PMID: 40372550BACKGROUND

  • 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.

    PMID: 36001711BACKGROUND

  • Kanatas P, Stouras I, Stefanis L, Stathopoulos P. B-Cell-Directed Therapies: A New Era in Multiple Sclerosis Treatment. Can J Neurol Sci. 2023 May;50(3):355-364. doi: 10.1017/cjn.2022.60. Epub 2022 May 16.

    PMID: 35570581BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting

Interventions

ublituximab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Farrah J Mateen, MD, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Gebczak, B.S.

CONTACT

630-313-0470caroline.gebczak@northwestern.edu

Dylan Rice, B.A.

CONTACT

240-362-4800dylan.rice@northwestern.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 29, 2025

First Posted

November 6, 2025

Study Start

November 28, 2025

Primary Completion (Estimated)

March 15, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)