Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis
A Pilot Study of Ublituximab in People With MS Experiencing Wearing Off Phenomena While Receiving Treatment With Ocrelizumab
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This small study tests whether switching from ocrelizumab to ublituximab can stop, ease, or delay MS symptoms that return or worsen between treatments. It is for adults with relapsing multiple sclerosis (MS) who have this “wearing-off” effect while taking ocrelizumab.
The proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a "wearing off" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Are 18 to 65 years old.
- Have a relapsing form of MS, which causes periods of new or worse symptoms.
- Have taken ocrelizumab on its usual schedule for at least one year.
- Can and are willing to continue treatment with ocrelizumab or ublituximab.
- Have worsening symptoms shown by study surveys between 1–2 months after an infusion and 1–2 months before the next one. Scores must move to a worse symptom level for sleep, tiredness, depression, or arm or leg function, or worsen by at least 10 points in any area.
Who can't join
- Ever used rituximab, ofatumumab, ublituximab, or another anti-CD20 drug besides ocrelizumab; cladribine, alemtuzumab, mitoxantrone, cyclophosphamide; or a blood stem cell transplant. Also excluded: an experimental biologic drug in the past 365 days.
- Have low infection-fighting blood cells: lymphocytes below 500/mm³ or neutrophils below 1.5 × 10⁹/L. Have a primary immune system disorder, or low immune proteins: IgG below 400 mg/dL or IgA below 10 mg/dL.
- Have an unstable medical or mental health condition, another uncontrolled illness that could affect safety or study results, or current drug or alcohol abuse or dependence.
- Had cancer in the past 5 years, except fully treated basal or squamous cell skin cancer or early cancer limited to the surface of the cervix.
- Take ongoing medicine to control a long-term infection, or had a hospital stay for infection or infection medicine by vein or injection within 60 days before screening.
- Test positive for hepatitis B surface antigen or core antibody, hepatitis C antibody, or tuberculosis at screening; or have a past or current positive HIV test.
- Have a lab result the study doctor considers medically important, a history of sensitivity to a study drug, or a condition that makes an MRI scan unsafe.
- Have trouble making decisions or giving informed consent, which means understanding and agreeing to join the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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 category, based on previously defined cutoff scores), a worsening of Neuro-QoL score of 10 points (which equals 1 SD) or more in any domain between a 1-2 month post-infusion assessment (after one ocrelizumab infusion) and a 1-2 month pre-infusion assessment (before the next scheduled infusion). Exclusion Criteria: * Prior therapy: Has ever received any of the following: * 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). * Infection history: * 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, neurological, malignancy or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk. * Hepatitis status: * 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.
Study sites (1)
MD
- Johns Hopkins University · Baltimore, MD 21287More trials in Baltimore