Phase 4 Multiple Sclerosis Trial, Recruiting NCT07389590 Sponsor: Johns Hopkins University Condition: Multiple Sclerosis
Back to Multiple Sclerosis

Phase 4 Multiple Sclerosis Trial, Recruiting

NCT07389590
Recruiting Phase 4

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
10 February 2026
Est. completion
1 October 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Proportion of Patients with Wearing-Off

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov