Ozanimod after anti-CD20 therapies for Relapsing Multiple Sclerosis
This study is looking at the safety and effectiveness of switching from anti-CD20 treatments to ozanimod (Zeposia®) in people with relapsing multiple sclerosis (MS). You might be able to join if you are at least 18 years old, have been diagnosed with relapsing MS for at least 3 years, and your MS has been stable without new inflammatory activity. Researchers will measure how many new T2 lesions (areas of damage in the brain or spinal cord) you have and how many serious infections occur over 36 months to see if this treatment approach is successful. The current status of this study is unclear, and it plans to enroll 100 participants.
- Study design
- This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll 100 participants and will follow them for 36 months.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 36 months to measure new T2 lesions and serious infections.
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NCT06529406
Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod
Recruiting
PHASE4Ages 18+InterventionalTreatmentUniversity of Colorado, DenverInvestigator-initiated
~100 participants
Updated 2025-09-18 on ClinicalTrials.gov
What's tested:Ozanimod
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
New T2 lesions count
Measured over 36 months
+1 more outcome measured
Conditions
Where it's being run
3 sites across 3 statesColorado1
Nevada1
Ohio1
Study leadership
- Enrique Alvarez, MD/PhD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants have been diagnosed with relapsing forms of MS and have had multiple sclerosis related symptoms at least 3 years prior to baseline visit
Male or female participants \> or = to 18 years of age at the time of initiation of de-escalation
Participants do not have evidence of new inflammatory disease activity (no new T2/contrast enhancing lesions, absence of relapses) for a minimum of two years prior to de-escalation
Participant is taking an anti-CD20 therapy as a DMT continuously for a minimum of two years (e.g., has received at least 3 courses of rituximab, ocrelizumab, ublituximab; 24 months of treatment with ofatumumab; or a combination of treatments whereby the patient has been deemed to be B-cell depleted for 2 years) prior to initiation of de-escalation
Participants received their last anti-CD20 infusion, including ocrelizumab subcutaneous injection, within 6-12 months or received their last ofatumumab injection within 30 -180 days from Day 1
Participants must provide written informed consent and be able to comply with the visit schedule and study related assessments
Participants must be able to undergo a brain MRI without anesthesia
Woman of Childbearing Potential must agree to practice a highly effective method of contraception throughout the study until completion and willing to follow pregnancy precautions.
Exclusion
Any progression of neurological disability in the year prior to the screening visit that would be consistent with progressive MS
Participant has an EDSS \>6.5
Participant has a history of other chronic neurological illnesses that might mimic MS with chronic or intermittent symptoms (i.e. ALS, myasthenia gravis, chronic neuropathy, etc.)
Participant is considering pregnancy in the short term, is pregnant, lactating or has a positive serum beta human chorionic gonadotropin (B-hCG) measured during screening.
Participant has any other significant medical or psychiatric illness, if uncontrolled, that could jeopardize a subject's health or put them at significant safety risk during the course of the study in the opinion of treating investigator. Examples: uncontrolled hypertension, uncontrolled diabetes, uncontrolled asthma, uncontrolled depression
Participant has a history of cancer within the last 5 years, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin or cervical dysplasia/cancer that has been excised and resolved)
Participant has a history in the last 6 months of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure
Participant has Mobitz type II second-degree or third degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker
Participant has severe untreated sleep apnea
Participant has a history of diabetes mellitus type 1, or uncontrolled diabetes mellitus type 2 with hemoglobin A1c (HbA1c) \> 9%, or is a diabetic subject with significant comorbid conditions such as retinopathy or nephropathy, or a history of uveitis
Participant has a history or known presence of recurrent or chronic infection (e.g., hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV); recurrent urinary tract infections are allowed.
Any known or suspected active infection (excluding onychomycosis) at screening, including but not limited to a confirmed or suspected progressive multifocal leukoencephalopathy (PML). Known currently active tuberculosis (TB). History of incompletely treated Mycobacterium tuberculosis (TB) infection, as indicated by: Subject's medical records documenting incomplete treatment for Mycobacterium TB; Subject's self-reported history of incomplete treatment for Mycobacterium TB; Subjects with a history of TB who have undergone treatment accepted by the local health authorities (within 1 year from screening) may be eligible for study entry.
Concomitant use of a monoamine oxidase inhibitor
Use of systemic corticosteroids in the last 2 years, except for the use as a premedication for B-cell depleting treatment (Note: Use of inhaled or topical steroids; use of oral steroids for no greater than 14 days given for a non-MS condition are allowed)
Prior use of alemtuzumab, mitoxantrone, cyclophosphamide, methotrexate, cyclosporine, or any experimental MS treatment within 5 half-lives
Prior allergy to ozanimod
Participant has IgG levels \<400 mg/dL
Participant has neutrophils \< 1500/μL (1.5 GI/L)
Participant has an absolute white blood cell (WBC) count \< 3500/μL (3.5 GI/L)
Participant has an absolute lymphocyte count (ALC) \< 800 cells/μL (0.80 GI/L).
Participant has liver function impairment or persisting elevations of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) results \> 3 x the upper limit of normal (ULN)
What this trial measures
- New T2 lesions count36 months
Number of new T2 lesions on MRI scans.
- Serious infections36 months
Infections requiring hospitalization, intravenous antibiotic use, or prolonged antibiotic use for treatment of an infection for at least 30 days.