Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07389590
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ublituximab — DRUG
    Ublituzimab will be administered via IV infusion as specified throughout the study period.
  • Ocrelizumab — DRUG
    Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.

Study Details

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.

Key Dates

Start date
Feb 10, 2026
Status verified
May 2026
Primary completion
Oct 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ublituximab
    Participants in this arm will switch from Ocrelizumab to receive Ublituximab administered intravenously (IV) as cumulative dose of 450-milligram (mg) infusions every 6 months for at least 2 doses.
  • Active Comparator: Ocrelizumab
    Participants in this arm will continue to receive Ocrelizumab administered intravenously (IV) as 600-milligram (mg) infusions every 6 months for at least a further 2 doses.

Primary Outcome Measure

Proportion of Patients with Wearing-Off [ Time Frame: From month 1 up to 11 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21287-

Find similar trials in Baltimore, MD

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Johns Hopkins University· Baltimore, MD

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