NCT07609719RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
A Prospective, Multicenter, Single-arm Study of Ocrelizumab Administered Subcutaneously in Patients With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) after switching from another anti-cluster of differentiation 20 (aCD20) therapy approved for RMS (ofatumumab SC, ublituximab-xiiy intravenous \[IV\], ocrelizumab IV) or PPMS (ocrelizumab IV).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 20 May 2026
- Start date
- 2 Sept 2026
- Primary completion date
- 28 Feb 2029
- Lead sponsor
- Genentech, Inc.
- Diseases
- Multiple sclerosis
- NCT number
- NCT07609719
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 2 Sept 2026 to the primary completion date, 28 Feb 2029
- 8 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Any concomitant disease that may require treatment with systemic corticosteroids (e.g., mineralocorticoids and glucocorticoids) or immunosuppressants during the study
- 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
Other illness
- 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
- Known allergy or hypersensitivity to ocrelizumab, rHuPH20, or excipients of the OCR SC formulation
- Positive hepatitis B virus (HBV) and hepatitis C virus (HCV) antibody test at screening
- Other protocol defined inclusion and exclusion criteria may apply.
Other
- Participants with contraindication to Gd+ and participants who for any reason cannot tolerate MRI procedure
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Caribbean Center for Clinical Research Coordinator of this site? Confirm its status | Guaynabo | Puerto Rico | Recruiting |
| Atlanta Neuroscience Institute Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Alabama Neurology Associates Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Neurology Clinic, PC Coordinator of this site? Confirm its status | Cordova | United States | Recruiting |
| Advanced Neurology of Colorado, LLC Coordinator of this site? Confirm its status | Fort Collins | United States | Recruiting |
| Neurology Associates PA Coordinator of this site? Confirm its status | Maitland | United States | Recruiting |
| Savannah Neurology Specialists,PC Coordinator of this site? Confirm its status | Savannah | United States | Recruiting |
| Clinical Endpoints, LLC Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.