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Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis

This study is looking at people with multiple sclerosis (MS) who are currently taking ocrelizumab but are experiencing a "wearing off" effect. This means their MS symptoms are returning or getting worse. The study will explore if switching to ublituximab can help resolve, improve, or delay these symptoms. You might be able to join if you are between 18 and 65 years old, have relapsing forms of MS, have been on ocrelizumab for at least a year, and are experiencing these wearing-off symptoms. The main goal is to see how many patients experience this wearing-off phenomenon over 1 to 11 months. The study is currently recruiting about 50 participants.

Study design
This is a pilot study involving about 50 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures the proportion of patients with wearing-off from month 1 up to 11 months.

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NCT07389590

Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis

Recruiting
PHASE4Ages 18–65InterventionalTreatment
Johns Hopkins University
~50 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:UblituximabOcrelizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Patients with Wearing-Off
Measured over From month 1 up to 11 months

Conditions

Multiple Sclerosis

Explore related trials

Multiple Sclerosis

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Shiv Saidha, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Ziyun Research Program Coordinator
[email protected]
410-614-1522
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Proportion of Patients with Wearing-OffFrom month 1 up to 11 months

    The proportion of patients with the wearing-off phenomenon (as defined below). Wearing off is defined as either worsening in any Neuro-QoL (Quality of Life in Neurological Disorders) 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) or 0.5-point worsening in average SymptoMScreen score.