Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
NCT07389590

Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis

Led by Johns Hopkins University · Updated on 2026-05-06

50

Participants Needed

1

Research Sites

159 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

T

TG Therapeutics, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
  • Presence of wearing off phenomena defined by worsening Neuro-QoL scores or symptom severity between scheduled infusions.
Not Eligible

You will not qualify if you...

  • Prior therapy with B-cell targeted therapies other than ocrelizumab, including rituximab, ofatumumab, ublituximab, or other anti-CD20 agents.
  • Prior use of cladribine, alemtuzumab, mitoxantrone, cyclophosphamide, or hematopoietic stem cell transplant.
  • Lymphocyte count less than 500/mm^3 within 6 months prior to screening.
  • Neutrophil count less than 1.5 x 10^9/L within 6 months prior to screening.
  • Clinically unstable medical or psychiatric disorders.
  • Current drug or alcohol abuse or dependence.
  • Received investigational biologic agents other than B-cell targeted therapy within 365 days prior.
  • History of malignancy in the past 5 years except treated skin cancers or carcinoma in situ of the cervix.
  • History of primary immunodeficiency.
  • Significant IgG deficiency (IgG level < 400 mg/dL).
  • IgA deficiency (IgA level < 10 mg/dL).
  • Current suppressive therapy for chronic infections or recent hospitalization or parenteral antibiotics for infection within 60 days.
  • Significant unstable or uncontrolled acute or chronic diseases that may affect study results or safety.
  • Positive tests for current or past hepatitis B or hepatitis C infection.
  • Positive HIV test.
  • Clinically significant abnormal laboratory assessments.
  • History of sensitivity to study medications.
  • Contraindications to MRI.
  • Positive tuberculosis test.
  • Impaired decision-making capacity or inability to provide informed consent.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Johns Hopkins University

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

Z

Ziyun Research Program Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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