Back to search results

Study of Ocrelizumab Subcutaneous for Multiple Sclerosis

This study is for people with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) who are switching from another approved anti-CD20 therapy. Researchers are testing a subcutaneous (under the skin) form of ocrelizumab (OCR SC) to see how well it works, if it's safe, and how satisfied patients are with it. The main goal is to see if participants have no new or fewer brain lesions (damaged areas) on their MRI scans after 24 weeks. You may be able to join if you are 18 to 65 years old, have a diagnosis of RMS or PPMS, and have an EDSS score (a measure of disability) between 0 and 6.5. The study aims to enroll 100 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 100 participants.
What's involved
Participants will receive OCR SC according to a specific schedule. Brain MRI scans will be taken at the beginning of the study and again at Week 24.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 24, indicating follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07609719

A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy

Recruiting
PHASE4Ages 18–65InterventionalTreatment
Genentech, Inc.
~100 participants
Updated 2026-09-08 on ClinicalTrials.gov
What's tested:OCR SC

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gadolinium-enhanced (Gd+) Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) at Week 24
Measured over Baseline, Week 24

Conditions

Multiple Sclerosis

Explore related trials

Acute relapsing multiple sclerosisPrimary progressive multiple sclerosis

NCT07609719

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Atlanta Neuroscience Institute

    Atlanta, Georgiano site contact published

    Recruiting

  • Caribbean Center for Clinical Research

    Guaynabo, Puerto Ricono site contact published

    Recruiting

  • Neurology Clinic PC

    Cordova, Tennesseeno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: ML46740 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S.)
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria
Documented Expanded Disability Status Scale (EDSS) score of 0-6.5, inclusive, at screening (or within 6 months of screening)
Participants discontinuing aCD20 therapy for reasons including, but not limited to, physician/participant preference, access to commercial drug (e.g., insurance coverage issues), or other logistical reasons (such as geographical relocation, travel, etc.) are eligible for this study
Prior treatment with ofatumumab SC, ublituximab-xiiy IV, or ocrelizumab IV aCD20 therapy

Exclusion

Participants who have demonstrated suboptimal response to aCD20 therapy
Discontinuing aCD20 therapy because of any of the following treatment emergent adverse events (TEAEs): 1) Grade ≥3 severe infusion-related reaction (IRRs) or injection reactions (IRs); 2) Recurrent Grade ≥3 infections, or the need for ≥2 courses of antibiotics in the 12 months prior to screening, if the investigator believes infection is related to therapy
Participants with contraindication to Gd+ and participants who for any reason cannot tolerate MRI procedure
Known presence of active, recurrent, or chronic infection (e.g., human immunodeficiency virus \[HIV\], syphilis, human papillomavirus \[HPV\], tuberculosis \[TB\])
History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
Known presence of neurologic disorders that may interfere with the diagnosis of RMS or PPMS
Any concomitant disease that may require treatment with systemic corticosteroids (e.g., mineralocorticoids and glucocorticoids) or immunosuppressants during the study
Known allergy or hypersensitivity to ocrelizumab, rHuPH20, or excipients of the OCR SC formulation
Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
Treatment with any live-attenuated vaccine within 6 weeks prior to baseline
Treatment with any experimental procedures for RMS or PPMS (e.g., treatment for chronic cerebrospinal venous insufficiency)
Previous treatment with cladribine, atacicept, alemtuzumab or mitoxantrone
Positive hepatitis B virus (HBV) and hepatitis C virus (HCV) antibody test at screening

What this trial measures

  • Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gadolinium-enhanced (Gd+) Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) at Week 24Baseline, Week 24