Recruiting

Ocrevus Zunovo

Sponsor:

Oklahoma Medical Research Foundation

Code:

NCT07878923

Conditions

Relapse Remitting Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

This study will compare starting Ocrevus Zunovo soon after an active episode of relapsing multiple sclerosis (MS) with starting it later. Researchers want to learn whether starting treatment sooner reduces the number of MS relapses over 18 months. They will also study changes in immune cells, blood markers, disability, and MRI scans.

About 35 adults with relapsing MS will take part at Oklahoma Medical Research Foundation or Corewell Health West. One group will start Ocrevus Zunovo before leaving the clinic or hospital. The other group will start treatment later. Ocrevus Zunovo is given as an injection under the skin. Participants will have blood draws and follow-up visits for up to 18 months. Researchers will also review their medical records for relapses, steroid treatments, emergency department visits, and hospital stays.

About 10 adults without MS will provide blood samples to help researchers compare immune cell measurements.

Conditions

Relapse Remitting Multiple Sclerosis

Study ID

NCT07878923

Start date

Sep 30, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Participants With Relapsing Multiple Sclerosis (Rapid-Start and Delayed-Start Cohorts)

Inclusion Criteria:

  • Age 18 years or older.
  • Diagnosis of relapsing-remitting multiple sclerosis according to the 2017 McDonald criteria.
  • At least one gadolinium-enhancing lesion on an MRI of the brain, cervical spine, or thoracic spine within 4 weeks of relapse or hospitalization.

Exclusion Criteria:

  • Diagnosis of primary progressive multiple sclerosis.
  • Active hepatitis B.
  • Current pregnancy.
  • Allergy to gadolinium contrast or known allergy to ocrelizumab.
  • Unable to complete an MRI.
  • Contraindication to or intolerance of oral or intravenous corticosteroids.
  • Another known neurological disorder, including a history of progressive multifocal leukoencephalopathy.
  • Active bacterial, viral, fungal, or mycobacterial infection, or a history of recurrent aspiration pneumonia requiring antibiotic treatment.
  • A condition that may require chronic systemic corticosteroids or immunosuppressants during the study.
  • Treatment with an anti-CD20 or other B-cell-depleting therapy within 6 months before enrollment.
  • Active cancer or malignancy.
  • Prisoner status.
  • Limited English-speaking capacity.
  • Unable to provide informed consent.

Healthy Control Participants

Inclusion Criteria:

  • Age 18 years or older.
  • Able and willing to provide written informed consent and undergo study blood draws.
  • No diagnosis or history of multiple sclerosis, clinically isolated syndrome, or another inflammatory or demyelinating disorder of the central nervous system.
  • In generally good health, as determined by medical history and investigator review.

Exclusion Criteria:

  • Multiple sclerosis, clinically isolated syndrome, myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), neuromyelitis optica spectrum disorder (NMOSD), or another neurological disorder that may affect study results.
  • An autoimmune, inflammatory, hematologic, or immunodeficiency disorder that may affect B- or T-cell measurements.
  • Active bacterial, viral, fungal, or mycobacterial infection at enrollment or blood collection.
  • Current use of a disease-modifying therapy, B-cell-depleting therapy, systemic immunosuppressant, immunomodulatory therapy, or chronic systemic corticosteroids.
  • Active cancer or malignancy, except adequately treated localized skin cancer if permitted by the investigator.
  • Current pregnancy.
  • A medical condition that, in the investigator's judgment, could increase risk, interfere with participation, or affect interpretation of immune cell or biomarker results.
  • Unable or unwilling to undergo blood collection.
  • Prisoner status.
  • Limited English-speaking capacity.
  • Unable to provide informed consent.

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

Rapid-Start MS Cohort

Approximately 18 adults with relapsing multiple sclerosis who begin Ocrevus Zunovo before leaving the clinic or at emergency department or hospital discharge. Participants are followed for 18 months to assess relapses, clinical outcomes, MRI findings, and blood biomarkers.

Delayed-Start MS Cohort

Approximately 17 adults with relapsing multiple sclerosis who begin Ocrevus Zunovo later in outpatient care. Participants are followed for 18 months using the same clinical and biomarker assessments as the rapid-start cohort.

Healthy Control Cohort

Approximately 10 adults without multiple sclerosis or another inflammatory or demyelinating disorder of the central nervous system. Blood samples are collected to provide comparison measurements for immune cell and biomarker analyses. These participants do not receive Ocrevus Zunovo.

Primary outcome measure

  • Annualized Relapse Rate Over 18 Months. [ Time Frame: From baseline through 18 months of follow-up. ]

Central Contacts and Locations

Central contacts

Yang Mao-Draayer, MD, PhD

4052716242Yang-Mao-Draayer@omrf.org

Locations

Oklahoma Medical Research Foundation

Recruiting

Oklahoma City, Oklahoma, United States, 73142

Contacts

Yang Mao-Draayer, MD, PhD

Yang-Mao-Draayer@omrf.org

Principal Investigator:

Yang Mao-Draayer, MD, PhD

More Information

Sponsor

Oklahoma Medical Research Foundation

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • Ocrevus Zunovo
  • Ocrelizumab
  • Relapsing Multiple Sclerosis
  • Early Treatment Initiation
  • B-Cell Depletion
  • Neurofilament Light Chain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-18. This information was provided to ClinicalTrials.gov by Oklahoma Medical Research Foundation on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.