Status:
RECRUITING
Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod
Lead Sponsor:
University of Colorado, Denver
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Detailed Description
Multicenter, Open Label, Prospective Study examining the safety and efficacy of de-escalation therapy to ozanimod (Zeposia®) over 36 months from anti-CD20 therapy for stable patients with relapsing fo...
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.
- 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)
Key Trial Info
Start Date :
July 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06529406
Start Date
July 29 2024
End Date
August 1 2029
Last Update
September 18 2025
Active Locations (3)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
Cleveland Clinic
Las Vegas, Nevada, United States, 89106
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195