Multiple SclerosisPhase 4NCT07225361
Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
A Phase 4 study testing Ublituximab in people with Multiple Sclerosis and Multiple Sclerosis (MS) - Relapsing-remitting, run by Northwestern University at 1 site in United States.
Trial summary
In this prospective, open-label, single-arm, single-institution trial, the investigators will accomplish the following two aims: 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
- What is being tested?
- Ublituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2025to 1 Aug 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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,
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Caroline Gebczak, B.S., 630-313-0470, caroline.gebczak@northwestern.edu
Dylan Rice, B.A., 240-362-4800, dylan.rice@northwestern.edu
About this study
In this prospective, open-label, single-arm, single-institution trial, the investigators will accomplish the following two aims:
- study the safety and tolerability of Ublituximab (Briumvi) twice annually in participants with early MS over a treatment observation period of ~12 months.
- 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.
Read the detailed description
PROCEDURES INVOLVED:
Participants will be enrolled for an estimated 96 weeks: Measurements will be requested every 24 weeks on a specifically designed survey instrument for participants. Participants will be asked to report medication dosing, adherence to medicine, tolerability, etc. as per Table 1. It is planned that each participant will be enrolled for 96 weeks (screening visit, baseline visit and four follow up visits at 24, 48, 72, and 96 weeks respectively) and would receive Ublituximab on an every 24 week schedule through regular clinical care. Notably, insurance may cover Ublituximab at an every 26 week schedule in which case accommodations will be made to have each study visit at q24-26 week intervals.
Participants will be contacted and interviewed every 24 weeks to ensure study procedures are going as planned, verify data reported on medication and MS disease history, and ensure study procedures are operating smoothly. Participants who do not complete the surveys within 7 days of the scheduled timing will be contacted by a study coordinator by phone up to 3 times. Participants will also be asked to report any medication changes, dose changes, or discontinuations if they occur at any point between study visits.
Participants will be enrolled until a total of 40 individual participants are reached. All scheduled events listed here will be part of the study and not part of routine clinical care. Study screening will continue until 40 participants are fully enrolled. Once 40 participants are enrolled, additional patients will not be screened or enrolled regardless of whether existing participants drop out of the study or are lost to follow-up. Five screen failures are estimated based on our study team's experience with ENHANCE (Ublituximab clinical trial). Once a participant is enrolled, the study will follow an intention to treat analysis.
- Being tested
- Ublituximab
- Keywords
- Ublituximab, Briumvi, Multiple Sclerosis, Relapsing Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UblituximabDrug
Also called Briumvi
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Relapsing Multiple Sclerosis | Experimental | Participants with Relapsing Multiple Sclerosis will be treated with Ublituximab for the duration of the study. Receives: Drug: Ublituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time Frame: Baseline (pre-treatment), and at 24, 48, 72, and 96 weeks post-treatment initiation
Secondary outcomes (1)
Safety of Ublituximab
The severity as well as the number of adverse events (AEs) and serious adverse events (SAEs), laboratory abnormalities, and infusion-related reactions throughout the study period.
Measured: From baseline through study completion, up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study start28 Nov 2025
- Primary completion15 Mar 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- TG Therapeutics, Inc.
- Responsible party
- Principal investigator, Farrah Mateen, Northwestern University
- Investigators
- Farrah J Mateen, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225361
- Sponsor's protocol ID
- STU00224712
- Status last verified
- Mar 2026
- First submitted
- 29 Oct 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36196979Canto 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.
PubMed 31403661Fitzgerald 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.
PubMed 35730070Kurtzke 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.
PubMed 6685237Sotirchos 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.
PubMed 36427295Freedman 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.
PubMed 40372550Steinman 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.
PubMed 36001711Kanatas 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.
PubMed 35570581
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07225361
- Acronym / sponsor ID
- STU00224712
- Keywords
- Ublituximab, Briumvi, Multiple Sclerosis, Relapsing Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- TG Therapeutics, Inc.
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 15 Mar 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 6 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective, open-label, single-arm, single-institution trial, the investigators will accomplish the following two aims:
- study the safety and tolerability of Ublituximab (Briumvi) twice annually in participants with early MS over a treatment observation period of ~12 months.
- 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.
Detailed description
PROCEDURES INVOLVED:
Participants will be enrolled for an estimated 96 weeks: Measurements will be requested every 24 weeks on a specifically designed survey instrument for participants. Participants will be asked to report medication dosing, adherence to medicine, tolerability, etc. as per Table 1. It is planned that each participant will be enrolled for 96 weeks (screening visit, baseline visit and four follow up visits at 24, 48, 72, and 96 weeks respectively) and would receive Ublituximab on an every 24 week schedule through regular clinical care. Notably, insurance may cover Ublituximab at an every 26 week schedule in which case accommodations will be made to have each study visit at q24-26 week intervals.
Participants will be contacted and interviewed every 24 weeks to ensure study procedures are going as planned, verify data reported on medication and MS disease history, and ensure study procedures are operating smoothly. Participants who do not complete the surveys within 7 days of the scheduled timing will be contacted by a study coordinator by phone up to 3 times. Participants will also be asked to report any medication changes, dose changes, or discontinuations if they occur at any point between study visits.
Participants will be enrolled until a total of 40 individual participants are reached. All scheduled events listed here will be part of the study and not part of routine clinical care. Study screening will continue until 40 participants are fully enrolled. Once 40 participants are enrolled, additional patients will not be screened or enrolled regardless of whether existing participants drop out of the study or are lost to follow-up. Five screen failures are estimated based on our study team's experience with ENHANCE (Ublituximab clinical trial). Once a participant is enrolled, the study will follow an intention to treat analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Relapsing Multiple Sclerosis | Experimental | Drug: UblituximabParticipants with Relapsing Multiple Sclerosis will be treated with Ublituximab for the duration of the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UblituximabAlso: BriumviCurrently, 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. | Drug | Participants with Relapsing Multiple Sclerosis |
Primary outcome
Change in plasma neurofilament light chain
Time frame: Time Frame: Baseline (pre-treatment), and at 24, 48, 72, and 96 weeks post-treatment initiation
Change in plasma neurofilament light chain concentration from baseline (pre-Ublituximab IV) to follow-up visits while on treatment longitudinally.
1 secondary outcome
Safety of Ublituximab
Time frame: From baseline through study completion, up to 96 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 36196979Vermunt 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.
- Background: PubMed 31403661Canto 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.
- Background: PubMed 35730070Fitzgerald 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.
- Background: PubMed 6685237Kurtzke 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.
- Background: PubMed 36427295Sotirchos 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.
- Background: PubMed 40372550Freedman 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.
- Background: PubMed 36001711Steinman 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.
- Background: PubMed 35570581Kanatas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Farrah J Mateen, MD, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ublituximab in people with Multiple Sclerosis and Multiple Sclerosis (MS) - Relapsing-remitting, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Gebczak, B.S. (630-313-0470, caroline.gebczak@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma neurofilament light chain (time frame: Time Frame: Baseline (pre-treatment), and at 24, 48, 72, and 96 weeks post-treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07225361, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.