Actively Recruiting
Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod
Led by University of Colorado, Denver · Updated on 2025-09-18
100
Participants Needed
3
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with relapsing forms of multiple sclerosis with symptoms at least 3 years before baseline visit
- Male or female aged 18 years or older at start of de-escalation
- No new inflammatory disease activity (no new brain lesions or relapses) for at least 2 years before de-escalation
- Continuous anti-CD20 therapy for at least 2 years prior to de-escalation
- Last anti-CD20 infusion received within 6-12 months or last ofatumumab injection within 30-180 days before Day 1
- Able to provide informed consent and comply with study visits and assessments
- Able to undergo brain MRI without anesthesia
- Women of childbearing potential agree to use highly effective contraception during the study and follow pregnancy precautions
You will not qualify if you...
- Neurological disability progression consistent with progressive MS in the year before screening
- Expanded Disability Status Scale (EDSS) score over 6.5
- History of other chronic neurological diseases mimicking MS
- Planning pregnancy, pregnant, breastfeeding, or positive pregnancy test at screening
- Significant uncontrolled medical or psychiatric illnesses posing safety risks
- History of cancer within last 5 years (except certain skin or cervical cancers resolved)
- Recent serious cardiac events or severe heart failure
- Certain heart conduction blocks without pacemaker
- Severe untreated sleep apnea
- History of type 1 diabetes or uncontrolled type 2 diabetes with serious complications
- History or presence of recurrent or chronic infections including HIV, hepatitis B or C
- Active infection at screening, including progressive multifocal leukoencephalopathy or active tuberculosis
- Use of monoamine oxidase inhibitors
- Use of systemic corticosteroids in last 2 years except as premedication for B-cell treatment
- Prior use of certain immunosuppressive or experimental MS treatments within 5 half-lives
- Allergy to ozanimod
- Low immunoglobulin G (IgG) levels below 400 mg/dL
- Low neutrophil, white blood cell, or lymphocyte counts below specified thresholds
- Liver function impairment or elevated liver enzymes above three times normal limits
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Cleveland Clinic
Las Vegas, Nevada, United States, 89106
Actively Recruiting
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
E
Enrique Alvarez, MD/PhD
CONTACT
L
Lilli Farrell, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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