Brief Summary

The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.

Trial Health

On Track

Trial Health Score

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

Enrollment

800

participants targeted

Target at P75+ for phase_3

Timeline

19mo left

Started Jun 2023

Typical duration for phase_3

Geographic Reach

2 countries

46 active sites

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

4.5 years study duration

Study Progress65%

Jun 2023Dec 2027

First Submitted

Initial submission to the registry

May 18, 2023

Completed

8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed

18 days until next milestone

Study Start

First participant enrolled

June 13, 2023

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 2, 2026

Status Verified

April 1, 2026

Enrollment Period

4.5 years

First QC Date

May 18, 2023

Last Update Submit

April 1, 2026

Conditions

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

Part A and Part C: Percentage of Participants With no Change or Reduction in Number of T1 Gd-Enhancing Lesions From Baseline to Week 48
The Gd-enhancing T1 lesions will be evaluated using magnetic resonance imaging (MRI) technique.
Baseline up to Week 48
Part B: Area Under the Curve Over the First 16 Weeks (AUC0-W16) of Ublituximab
Predose and at multiple timepoints up to Week 16

Secondary Outcomes (3)

Parts A: Percentage of Participants Free of T1 Gd-Enhancing Lesions
Week 48
Parts A and B: Percentage of Participants Experiencing Infusion Related Reactions (IRRs)
Up to Week 48
Parts A: Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
Part A: Baseline, Week 24 and Week 48

Study Arms (4)

Part A: Ublituximab

EXPERIMENTAL

Participants will receive a modified regimen of ublituximab including infusions on Day 1 of Week 1 (W1D1), Day 15, if applicable, and ublituximab 450 milligrams (mg) infusion at Week 24. With Protocol Version 6.0, enrollment in Part A was closed.

Biological: Ublituximab

Part B: Ublituximab /Placebo (Treatment Arm A)

EXPERIMENTAL

Participants will receive 600 mg of ublituximab on W1D1 followed by a placebo infusion on Day 15 and 450 mg ublituximab infusion at Week 24. With Protocol Version 7.0, enrollment in Part B will be closed.

Biological: UblituximabDrug: Placebo

Part B: Ublituximab (Treatment Arm B)

EXPERIMENTAL

Participants will receive 150 mg of ublituximab on W1D1 followed by 450 mg on Day 15 and at Week 24. With Protocol Version 7.0, enrollment in Part B will be closed.

Biological: Ublituximab

Part C: Ublituximab (Treatment Arm C)

EXPERIMENTAL

Participants will receive 150 mg of ublituximab on W1D1, followed by 450 mg on Day 15 and at Week 24.

Biological: Ublituximab

Interventions

UblituximabBIOLOGICAL

Administered as an intravenous (IV) infusion.

Also known as: TG-1101, BRIUMVI

Part A: UblituximabPart B: Ublituximab (Treatment Arm B)Part B: Ublituximab /Placebo (Treatment Arm A)Part C: Ublituximab (Treatment Arm C)

PlaceboDRUG

IV infusion

Part B: Ublituximab /Placebo (Treatment Arm A)

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of RMS (2017 Revised McDonald criteria).
Participants must meet one of the following prior treatment definitions:
Participants naïve to treatment.
Participants previously treated with a disease modifying therapy (DMT) who have discontinued treatment prior to consent and meet the washout requirements.
Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
Neurologically stable for \> 30 days prior to first dose of ublituximab.
Female participants of childbearing potential must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 6 months after the last dose of ublituximab.
Part C: participants currently treated with an anti-CD20 agent for at least 6 months and meet the washout requirements prior to W1D1.
Part C: Discontinuation of current anti-CD20 must be due to suboptimal experience

You may not qualify if:

History of any serious 3 Infusion Related Reaction (IRR) on prior anti-CD20 therapy.
Primary-progressive multiple sclerosis (PPMS) or inactive Secondary Progressive MS (SPMS).
Active chronic (or stable but treated with immune therapy) disease of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.).
Current evidence or known history of clinically significant infection, including: chronic, recurrent, or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment such as, but not limited to chronic urinary tract infection, chronic pulmonary infection with bronchiectasis, tuberculosis, or active hepatitis C virus (HCV).
Previous serious opportunistic or atypical infection.
Evidence of chronic active or history of hepatitis B virus (HBV) infection as evidenced by a detectable hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb), or chronic hepatitis C infection. Participants with positive hepatitis C virus antibody (HCV Ab) are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
History or evidence (clinical, radiological, or biomarker) of suspected or confirmed progressive multifocal leukoencephalopathy (PML).
Receipt of any live or live-attenuated vaccines (including vaccines for varicella-zoster virus or measles) within 4 weeks prior to first study drug administration.
Participants requiring treatment with intravenous immune globulin (IVIG) for decreased immunoglobulins within the 12 months prior to W1D1.
Any active malignancies other than adequately treated basal, squamous cell or in situ carcinoma.
Participants who have ever received ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab (including for non-MS indications).

Contact the study team to confirm eligibility.