BridgeMD
Tests treatment safety and results for Relapsing Multiple Sclerosis
Official title Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
ClinicalTrials.gov ID: NCT05877963
What this study is testing
What is Ublituximab?
Ublituximab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsing multiple sclerosis.
Also referred to as TG-1101, BRIUMVI.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
You likely can't join 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...
- Current evidence or known history of clinically significant infection, including: chronic, recurrent, or ongoing active viral, bacterial, or fungal...
- 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...
See the full eligibility criteria
- 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
- 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...
- 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...
- 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...
- 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). Note: Other Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Cullman, Alabama, United States
- Orange, California, United States
- Fort Collins, Colorado, United States
- Washington D.C., District of Columbia, United States
- Tampa, Florida, United States
- Savannah, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Overland Park, Kansas, United States
- Lutherville, Maryland, United States
- Boston, Massachusetts, United States
- Foxborough, Massachusetts, United States
- North Worcester, Massachusetts, United States
- Wellesley, Massachusetts, United States
- Farmington, Michigan, United States
- Golden Valley, Minnesota, United States
- Plymouth, Minnesota, United States
- St Louis, Missouri, United States
+ 25 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Cullman, Alabama, United States; Orange, California, United States; Fort Collins, Colorado, United States; Washington D.C., District of Columbia, United States; Tampa, Florida, United States and 39 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.