Who is eligible for clinical trial NCT07389590?

Participants must meet protocol criteria for Multiple Sclerosis. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07389590 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-01

Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis (NCT07389590)

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Johns Hopkins University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (27 items).

Location: Johns Hopkins University — Baltimore, Maryland

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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).

Usually NOT eligible if any of the following apply:

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).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Johns Hopkins University — Baltimore, Maryland

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗