NCT06529406 Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod
| NCT ID | NCT06529406 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Colorado, Denver |
| Condition | Relapsing Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-07-29 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2024-07-29 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A multi-center pilot study to evaluate safety and efficacy of ozanimod as de-escalation therapy in clinically stable MS patients previously treated with anti-CD20 therapy.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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. Exclusions related to Medications: * 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 Exclusions related to Laboratory results: * 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)
Contact & Investigator
Enrique Alvarez, MD/PhD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT06529406 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsing Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06529406 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06529406 currently recruiting?
Yes, NCT06529406 is actively recruiting participants. Contact the research team at enrique.alvarez@cuanschutz.edu for enrollment information.
Where is the NCT06529406 trial being conducted?
This trial is being conducted at Aurora, United States, Las Vegas, United States, Cleveland, United States.
Who is sponsoring the NCT06529406 clinical trial?
NCT06529406 is sponsored by University of Colorado, Denver. The principal investigator is Enrique Alvarez, MD/PhD at University of Colorado, Denver. The trial plans to enroll 100 participants.
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