Phase 4 Multiple Sclerosis Trial, Recruiting NCT07225361 Sponsor: Northwestern University Condition: Multiple Sclerosis
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Phase 4 Multiple Sclerosis Trial, Recruiting

NCT07225361
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 been confirmed by a neurologist to meet the 2024 diagnostic criteria for Multiple Sclerosis (MS), which may include findings from brain or spinal cord scans, eye nerve involvement, or specific markers found in spinal fluid or on MRI
  • Adults between 18 and 70 years of age
  • People whose MS-related disability level is very low, measured by a standard scale called the EDSS, with a score below 2.5 (confirm with trial site)
  • People who are able to give their own informed consent to participate
  • People who have an MRI brain scan available that confirms the MS diagnosis and shows fewer than 10 areas of nerve damage (lesions)
  • People diagnosed with MS within the past 5 years
  • People who are planning to begin treatment with the medication Ublituximab for relapsing MS

Who may not be able to join:

  • People who have previously been treated with Mavenclad, Lemtrada, Cyclophosphamide, a stem cell transplant, or similar bone marrow-suppressing treatments
  • People who have previously been treated with other B-cell depleting medications, including Ocrelizumab, Rituximab, Ofatumumab, or Inebilizumab
  • People who are currently participating in another clinical trial
  • People who do not speak a language for which translation services are available within the hospital system
  • People whose MS diagnosis or treatment history is not clearly documented
  • People who have had a major surgical procedure within the past 6 months
  • People with a history of a life-threatening reaction to Ublituximab or a similar medication
  • People with active Hepatitis B infection, confirmed by specific blood tests
  • People who have received a live or live-attenuated vaccine within 4 weeks before the first dose of the study medication
  • People who are in a very advanced stage of illness with a very limited life expectancy (confirm with trial site)
  • People who are unable to give consent voluntarily, such as those with reduced decision-making capacity or people who are incarcerated
  • People who are unwilling to have blood drawn as part of the study
  • People for whom access to Ublituximab through their insurance or health coverage cannot be maintained throughout the full 96-week study period
  • People whom the study investigators determine are unable to complete the study activities for any reason

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 28 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: Farrah J Mateen, MD, PhD, Northwestern University

Phone: 630-313-0470

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
28 November 2025
Est. completion
15 March 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in plasma neurofilament light chain

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: 28 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