Phase 4 Multiple Sclerosis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have a relapsing form of multiple sclerosis (MS), meaning their MS involves episodes of new or worsening symptoms.
- People aged between 18 and 65 years old (inclusive).
- People who have been receiving ocrelizumab (a standard MS infusion treatment) at its regular scheduled intervals for at least one year.
- People whose doctor considers them suitable to continue treatment with either ocrelizumab or ublituximab (another similar MS infusion treatment).
- People who have experienced a "wearing off" effect — meaning certain symptoms such as sleep problems, fatigue, depression, or difficulties with arm or leg function get noticeably worse in the weeks before their next scheduled infusion compared to how they felt shortly after their last infusion.
Who may not be able to join:
- People who have previously received other B-cell targeting treatments such as rituximab, ofatumumab, ublituximab, or similar medicines (apart from ocrelizumab).
- People who have previously been treated with cladribine, alemtuzumab, mitoxantrone, cyclophosphamide, or a stem cell transplant.
- People whose blood tests show a low level of a particular type of white blood cell called lymphocytes (below 500 per mm³), based on results from within the past 6 months.
- People whose blood tests show a low level of another type of white blood cell called neutrophils, based on results from within the past 6 months.
- People who have an unstable medical or psychiatric condition at the time of screening.
- People who are currently misusing drugs or alcohol.
- People who have received a certain type of experimental biological treatment (other than B-cell targeted therapies) within the past 365 days.
- People who have had a cancer diagnosis in the past 5 years, with the exception of certain treated skin cancers or a specific non-spreading cervical condition.
- People who have a history of a primary immune deficiency (a condition present from birth or early life where the immune system does not work properly).
- People whose blood tests show significantly low levels of certain immune proteins called IgG (below 400 mg/dL) or IgA (below 10 mg/dL).
- People who are currently taking ongoing medication to suppress a chronic infection such as tuberculosis, CMV, herpes, or similar conditions.
- People who were hospitalised for an infection within the 60 days before screening.
- People who received antibiotic, antiviral, antifungal, or antiparasitic treatment by injection or drip within the 60 days before screening.
- People who have significant unstable or uncontrolled ongoing conditions affecting the heart, lungs, blood, digestive system, liver, or other major body systems, which the trial doctor believes could affect the study results or the person's safety.
- People who test positive for Hepatitis B (either current or past infection based on specific blood markers) or Hepatitis C antibody.
- People who have a known positive HIV test result, or who test positive for HIV at screening.
- People whose blood test results show abnormalities that the trial doctor considers clinically significant.
- People who have a known sensitivity or allergic reaction to any of the study medications.
- People who are unable to have an MRI scan for any reason.
- People who test positive for tuberculosis at screening.
- People who are unable to make their own decisions or who are unable to provide informed consent to participate.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Shiv Saidha, MD, Johns Hopkins University
Phone: 410-614-1522
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Proportion of Patients with Wearing-Off
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.