Phase 4 Multiple Sclerosis Trial, Recruiting NCT06529406 Sponsor: University of Colorado, Denver Condition: Multiple Sclerosis
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Phase 4 Multiple Sclerosis Trial, Recruiting

NCT06529406
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:

  • You have been diagnosed with a relapsing form of multiple sclerosis (MS), and have had MS-related symptoms for at least 3 years before your first study visit
  • You are 18 years of age or older at the time the study treatment change begins
  • You have shown no signs of new MS disease activity (no new lesions on brain scans and no relapses) for at least the past 2 years
  • You have been continuously taking a specific type of MS medication called an anti-CD20 therapy (such as rituximab, ocrelizumab, ublituximab, or ofatumumab) for at least 2 years
  • You received your last dose of anti-CD20 infusion or injection within a specific recent time window (confirm with trial site for exact timing based on your medication)
  • You are able and willing to give written consent and attend all required study visits and assessments
  • You are able to have a brain MRI scan without needing general anesthesia
  • If you are a woman who could become pregnant, you must agree to use a highly effective form of birth control throughout the study and follow pregnancy safety guidelines

Who may not be able to join:

  • Your MS disability has gotten noticeably worse in the past year in a way that suggests a progressive form of MS
  • Your disability level is above a certain threshold on a standard MS disability scale (confirm with trial site)
  • You have another long-term neurological condition that can look similar to MS, such as ALS or myasthenia gravis
  • You are pregnant, breastfeeding, planning to become pregnant soon, or had a positive pregnancy test during screening
  • You have another significant medical or psychiatric condition that is not well controlled, such as uncontrolled high blood pressure, diabetes, asthma, or depression
  • You have had a cancer diagnosis in the last 5 years (with some exceptions for certain minor skin conditions — confirm with trial site)
  • You have had a heart attack, stroke, unstable chest pain, mini-stroke, or serious heart failure episode in the last 6 months
  • You have certain types of heart rhythm problems, unless you already have a working pacemaker
  • You have severe sleep apnea that is not being treated
  • You have Type 1 diabetes, poorly controlled Type 2 diabetes, or diabetes with serious related complications such as eye or kidney problems, or a history of a specific eye inflammation condition
  • You have a history of certain ongoing or recurring infections, such as hepatitis B, hepatitis C, or HIV (recurrent urinary tract infections are generally allowed)
  • You currently have any active infection, or have a history of tuberculosis that was not fully treated
  • You are currently taking a type of medication called a monoamine oxidase inhibitor (MAOI)
  • You have used steroid medications regularly (by mouth or injection) in the last 2 years, with some limited exceptions
  • You have previously been treated with certain strong MS or immune-suppressing medications such as alemtuzumab or mitoxantrone within a recent period (confirm with trial site)
  • You have had an allergic reaction to a medication called ozanimod
  • Your blood test results show that certain immune proteins or blood cell counts are below acceptable levels (confirm with trial site for specific values)
  • Your liver function blood tests show results significantly above the normal range

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: Enrique Alvarez, MD/PhD, University of Colorado, Denver

Phone: 303-724-8249

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
29 July 2024
Est. completion
1 August 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

New T2 lesions count; Serious infections

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