Relapsing Multiple SclerosisPhase 4COASTNCT06529406
Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod
A Phase 4 study testing Ozanimod in people with Relapsing Multiple Sclerosis, run by University of Colorado, Denver at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Ozanimod
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jul 2024to 1 Aug 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 23Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lilli Farrell, BS contact
United States3 sites, 3 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Enrique Alvarez, MD/PhD, 303-724-8249, enrique.alvarez@cuanschutz.edu
Haley Steinert, 303-724-4644, neuroresearch@cuanschutz.edu
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Devon S Conway, MD, 216-636-1158, conwayd2@ccf.org
Devon S Conway, MD
- Recruiting
Cleveland Clinic
Las Vegas, Nevada, 89106
Liza Mercurio, 725-373-1590, mercurl2@ccf.org
Carrie M Hersh, DO
About this study
Official title: Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod (COAST: CD20 and Ozanimod Sequencing Trial)
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.
Read the 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 forms of MS. A comparison to patients continuing anti-CD20 treatment was performed with propensity scoring to a cohort of at least 500 patients followed at Cleveland Clinic and the University of Colorado who also meet the above the inclusion and exclusion criteria. Patients were followed for 36 months.
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Ozanimod
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzanimodDrug
Also called Zeposia
De-escalation of anti-CD20 treatment using ozanimod.
| Study group | Role | What they receive |
|---|---|---|
| Ozanimod de-escalation of anti-CD20 treatment | Experimental | Ozanimod will be started 6-12 months after the last anti-CD20 infusion, including ocrelizumab subcutaneous injection, or 30-180 days from their last ofatumumab injection. Ozanimod will be provided by the study. Receives: Drug: Ozanimod |
| Continued anti-CD20 treatment | No intervention | Patients will continue to receive anti-CD20. Propensity score matched to the experimental arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
New T2 lesions count
Number of new T2 lesions on MRI scans.
Measured: 36 months
Serious infections
Infections requiring hospitalization, intravenous antibiotic use, or prolonged antibiotic use for treatment of an infection for at least 30 days.
Measured: 36 months
Secondary outcomes (7)
Relapses
Protocol and/or suspected relapses
Measured: 36 months
IgG and IgM levels
IgG and IgM levels
Measured: 36 months
Infections
All infections including opportunistic infections.
Measured: 36 months
No Evidence of Disease Activity (NEDA-3)
Not meeting any of the following criteria:
- Evidence of Relapse activity - collected every 3 months via phone calls/clinic visits.
- MRI disease activity - presence of new T2 lesions from MRI scans conducted at any timepoint.
- 6 months Confirmed Disability progression (CDP6): measured by the EDSS assessed at baseline and every 6 months. CDP6 is defined as an increase in Expanded Disability Status Scale (EDSS) score of ≥1.5 if baseline EDSS was 0; or ≥1.0 points if baseline EDSS was ≥0.5-≤5.5; or by ≥0.5 points if baseline EDSS ≥6, sustained over two consecutive visits.
Measured: 36 months
Neurofilament light (NfL) and Glial Fibrillary Acid Protein (GFAP)
Neurofilament light (NfL) and Glial Fibrillary Acid Protein (GFAP)
Measured: 36 months
Brain parenchymal and thalamic volume loss
Brain parenchymal and thalamic volume loss
Measured: 36 months
Adverse Events
Adverse Events
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start29 Jul 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Ozanimod de-escalation of anti-CD20 treatment vs continued treatment.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrique Alvarez, MD/PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529406
- Sponsor's protocol ID
- 23-1686
- Acronym
- COAST
- Status last verified
- Sep 2025
- First submitted
- 26 Jul 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with interest in multiple sclerosis. Data or samples shared will be coded with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod (COAST: CD20 and Ozanimod Sequencing Trial)
- ClinicalTrials.gov ID
- NCT06529406
- Acronym / sponsor ID
- COAST / 23-1686
- Conditions
- Relapsing Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 forms of MS. A comparison to patients continuing anti-CD20 treatment was performed with propensity scoring to a cohort of at least 500 patients followed at Cleveland Clinic and the University of Colorado who also meet the above the inclusion and exclusion criteria. Patients were followed for 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Ozanimod de-escalation of anti-CD20 treatment vs continued treatment.
| Arm | Type | Receives |
|---|---|---|
| Ozanimod de-escalation of anti-CD20 treatment | Experimental | Drug: OzanimodOzanimod will be started 6-12 months after the last anti-CD20 infusion, including ocrelizumab subcutaneous injection, or 30-180 days from their last ofatumumab injection. Ozanimod will be provided by the study. |
| Continued anti-CD20 treatment | No intervention | –Patients will continue to receive anti-CD20. Propensity score matched to the experimental arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzanimodAlso: ZeposiaDe-escalation of anti-CD20 treatment using ozanimod. | Drug | Ozanimod de-escalation of anti-CD20 treatment |
Primary outcome
New T2 lesions count
Time frame: 36 months
Number of new T2 lesions on MRI scans.
Serious infections
Time frame: 36 months
Infections requiring hospitalization, intravenous antibiotic use, or prolonged antibiotic use for treatment of an infection for at least 30 days.
7 secondary outcomes
Relapses
Time frame: 36 months
IgG and IgM levels
Time frame: 36 months
Infections
Time frame: 36 months
No Evidence of Disease Activity (NEDA-3)
Time frame: 36 months
Neurofilament light (NfL) and Glial Fibrillary Acid Protein (GFAP)
Time frame: 36 months
Brain parenchymal and thalamic volume loss
Time frame: 36 months
Adverse Events
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with interest in multiple sclerosis. Data or samples shared will be coded with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lilli Farrell, BS contact
Enrique Alvarez, MD/PhD principal investigator
University of Colorado, Denver
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ozanimod in people with Relapsing Multiple Sclerosis, run by University of Colorado, Denver at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enrique Alvarez, MD/PhD (303-724-8249, enrique.alvarez@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New T2 lesions count (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.