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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

NCT07389590•Johns Hopkins University

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.
+16 more criteria

Locations (1)

Johns Hopkins University

Baltimore, Maryland, United States

Key Dates

Start Date

February 1, 2026

Primary Completion Date

October 1, 2028

Completion Date

March 1, 2029

Last Updated

February 5, 2026

Enrollment

ESTIMATED participants

Conditions

Multiple Sclerosis

Interventions

Ublituximab

DRUG

Ocrelizumab

DRUG

Contacts

Ziyun Research Program Coordinator

CONTACT

410-614-1522 zwang306@jhu.edu

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Secondary Progressive Multiple Sclerosis (SPMS)

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis

Inclusion Criteria

Exclusion Criteria

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