A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Recruiting · NCT07609719 · Interventional (participants receive a specific treatment) · Lead sponsor: Genentech, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
OCR SC
What this trial is about
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).
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
- ther protocol defined inclusion and exclusion criteria may apply.
Where it is running
3 locations listed across 2 US states.
- Atlanta Neuroscience Institute - Atlanta, Georgia, United States
- Neurology Clinic PC - Cordova, Tennessee, United States
- Caribbean Center for Clinical Research - Guaynabo, Puerto Rico