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New hope for MS patients: can a drug switch stop symptom comebacks?
NCT ID NCT07389590
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests whether switching from ocrelizumab to ublituximab can reduce or delay the return of MS symptoms that some patients experience before their next scheduled infusion. Researchers will enroll 50 adults with relapsing MS who have been on ocrelizumab for at least a year and report this 'wearing-off' phenomenon. Participants will be monitored for changes in symptom severity and quality of life over several infusion cycles.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ublituximab
- What this could lead to
- If it works, this could offer a new option for people with MS whose symptoms return before their next infusion, improving their quality of life.
- What could go wrong
- This is a small pilot study, so results may not apply to everyone. The benefit may be small or not seen at all, and switching drugs carries its own risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins University
RECRUITINGBaltimore, Maryland, 21287, United States
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