Multiple Sclerosis study: Ublituximab vs Ocrelizumab
Official title Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis
ClinicalTrials.gov ID: NCT07389590
What this study is testing
What is Ublituximab?
An investigational IV infusion medicine being studied as a potential treatment for multiple sclerosis. It is designed to bind to the CD20 protein on B‑cells and reduce their activity.
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 study aims to see if switching to ublituximab can resolve, improve, or delay the symptom worsening that some patients experience while on ocrelizumab.
- Who it's for
- People with multiple sclerosis who are currently receiving ocrelizumab and notice a return or worsening of symptoms.
- What's involved
- Participants will stop ocrelizumab and start treatment with ublituximab, with scheduled clinic visits and tests to monitor their condition.
- Phase 4: studies an already-approved treatment
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
- Patients with relapsing forms of MS.
- Age between 18 and 65 years old (inclusive).
- On treatment with standard interval ocrelizumab for at least one year.
- Eligible and willing to continue treatment with ocrelizumab or ublituximab.
- The presence of wearing off phenomena, defined as either worsening in any Neuro-QoL sleep disturbance, fatigue, depression, upper and lower extremity...
You likely can't join if
- B-cell targeted therapies: rituximab, ofatumumab, ublituximab or other anti-CD20 agents besides ocrelizumab.
- Prior use of cladribine, alemtuzumab, mitoxantrone, cyclophosphamide or HSCT.
- Lymphopenia: a lymphocyte count \<500/ millimeter (mm)\^3. Historical labs may be used if the collection date is 6 months or less prior to deeming...
- Neutrophils \<1.5X10E9/L. Historical labs may be used if the collection date is 6 months or less prior to deeming eligible.
- Clinically unstable medical or psychiatric disorder.
- Substance abuse: has evidence of current drug or alcohol abuse or dependence.
See the full eligibility criteria
- Patients with relapsing forms of MS.
- Age between 18 and 65 years old (inclusive).
- On treatment with standard interval ocrelizumab for at least one year.
- Eligible and willing to continue treatment with ocrelizumab or ublituximab.
- The presence of wearing off phenomena, defined as either worsening in any Neuro-QoL sleep disturbance, fatigue, depression, upper and lower extremity scores (moving from a lower category of symptom severity to a higher...
- B-cell targeted therapies: rituximab, ofatumumab, ublituximab or other anti-CD20 agents besides ocrelizumab.
- Prior use of cladribine, alemtuzumab, mitoxantrone, cyclophosphamide or HSCT.
- Lymphopenia: a lymphocyte count \<500/ millimeter (mm)\^3. Historical labs may be used if the collection date is 6 months or less prior to deeming eligible.
- Neutrophils \<1.5X10E9/L. Historical labs may be used if the collection date is 6 months or less prior to deeming eligible.
- Clinically unstable medical or psychiatric disorder.
- Substance abuse: has evidence of current drug or alcohol abuse or dependence.
- 365 Day prior therapy: has received a biologic investigational agent other than B-cell targeted therapy [e.g., anti CD40L antibody].
- Malignancy: has a history of malignancy in the past 5 years except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
- Have a history of a primary immunodeficiency.
- Have a significant IgG deficiency (IgG level \< 400 mg/dL).
- Have an IgA deficiency (IgA level \< 10 mg/dL).
- Currently on any suppressive therapy for chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, and atypical mycobacteria).
- Hospitalization for treatment of infection within 60 days of Screening.
- Use of parenteral (IV or IM) antibiotics (anti-bacterial, antiviral, anti-fungal, or anti-parasitic agents) within 60 days of Screening.
- Other disease/conditions: has any of the following: a) clinical evidence of significant unstable or uncontrolled acute or chronic diseases (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic...
- Serologic evidence of current or past Hepatitis B (HB) infection based on the results of testing for HBsAg and HBcAb as follows: Patients positive for HBsAg or HBcAb are excluded.
- A positive test for Hepatitis C antibody
- HIV: known to have a historically positive HIV test or tests positive at screening for HIV.
- Laboratory abnormalities: An abnormal laboratory assessment is made, which is judged clinically significant by the investigator.
- Drug Sensitivity: has a history of sensitivity to any of the study medications.
- Any contraindication to undergoing MRI.
- TB: tests positive at screening for tuberculosis.
- Impaired decision-making capacity or impaired ability to provide informed consent.
The study team makes the final eligibility decision.
Where it is enrolling
- Baltimore, Maryland, United States
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, but 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?
This study is enrolling now at Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.