Actively Recruiting
Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod (COAST: CD20 and Ozanimod Sequencing Trial)
Led by University of Colorado, Denver · Updated on 2025-09-18
100
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of ozanimod as a de-escalation therapy in patients with relapsing forms of multiple sclerosis (MS) who have been clinically stable and previously treated with anti-CD20 therapies. This multicenter, open-label, prospective study aims to evaluate the safety and effectiveness of switching to ozanimod compared to continuing anti-CD20 treatment over a 36-month period. The study includes a comparison group of patients continuing anti-CD20 therapy to better understand outcomes in stable MS patients. Participants in the experimental group will begin ozanimod treatment 6 to 12 months after their last anti-CD20 infusion, including subcutaneous ocrelizumab, or 30 to 180 days after their last ofatumumab injection. Ozanimod will be provided by the study. The comparison group will continue their anti-CD20 treatment. The study follows patients for 36 months to monitor and compare the two approaches. Throughout the study, participants will undergo various assessments including brain MRI scans, laboratory tests, and monitoring for new T2 lesions and serious infections. Researchers will also track relapses, immunoglobulin levels, infection rates, disease activity status, brain volume changes, and adverse events. Participants must be able to comply with visit schedules, undergo brain MRI without anesthesia, and follow contraception guidelines if applicable. The study continues for 36 months, allowing detailed evaluation of long-term outcomes and safety.
CONDITIONS
Brief 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 and had symptoms for at least 3 years before baseline
- Male or female participants aged 18 years or older at the start of de-escalation
- No new inflammatory disease activity (no new T2/contrast enhancing lesions or relapses) for at least 2 years before de-escalation
- Continuous use of anti-CD20 therapy as disease-modifying treatment for at least 2 years prior to de-escalation
- Received last anti-CD20 infusion (including ocrelizumab subcutaneous injection) within 6-12 months or last ofatumumab injection within 30-180 days before Day 1
- Able to provide written informed consent and comply with visit schedules and assessments
- Able to undergo brain MRI without anesthesia
- Women of childbearing potential must agree to use effective contraception throughout the study and follow pregnancy precautions
You will not qualify if you...
- Any neurological disability progression in the year before screening consistent with progressive MS
- Expanded Disability Status Scale (EDSS) score greater than 6.5
- History of other chronic neurological illnesses mimicking MS (e.g., ALS, myasthenia gravis, chronic neuropathy)
- Planning pregnancy soon, pregnant, lactating, or positive pregnancy test at screening
- Significant uncontrolled medical or psychiatric illnesses posing safety risks (e.g., uncontrolled hypertension, diabetes, asthma, depression)
- History of cancer in the last 5 years except certain skin or cervical cancers that were excised
- Recent history (last 6 months) of serious heart conditions including heart attack, stroke, or severe heart failure
- Certain heart conduction abnormalities unless treated with a pacemaker
- Severe untreated sleep apnea
- History of type 1 diabetes or uncontrolled type 2 diabetes with complications
- History or presence of recurrent or chronic infections like hepatitis B, hepatitis C, or HIV
- Any active infection or known tuberculosis at screening
- Use of monoamine oxidase inhibitors
- Use of systemic corticosteroids in the last 2 years except as premedication for B-cell depletion
- Prior use of certain immunosuppressive or experimental MS treatments within 5 half-lives
- Prior 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 3 times the upper limit of normal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants receive either de-escalation therapy to ozanimod starting 6-12 months after their last anti-CD20 infusion or continue anti-CD20 treatment as part of the study.
Regular visits during treatment as per protocol
Duration - Up to 36 months
Participants are followed for safety and efficacy outcomes for the duration of 36 months after starting treatment.
Visits aligned with treatment schedule for ongoing assessments
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
L
Lilli Farrell, BS
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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