A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Purpose
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).
Condition
- Multiple Sclerosis
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Other protocol defined inclusion and exclusion criteria may apply.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental OCR SC |
Participants will receive OCR SC, 920 milligrams (mg) at Day 1 and at Week 24. |
|
Recruiting Locations
Atlanta Neuroscience Institute
Atlanta, Georgia 30327
Atlanta, Georgia 30327
Neurology Clinic PC
Cordova, Tennessee 38108
Cordova, Tennessee 38108
Caribbean Center for Clinical Research
Guaynabo, Puerto Rico 00968
Guaynabo, Puerto Rico 00968
More Details
- Status
- Recruiting
- Sponsor
- Genentech, Inc.
Study Contact
Reference Study ID Number: ML46740 https://forpatients.roche.com/ No attachments to email below.888-662-6728 (U.S.)
global-roche-genentech-trials@gene.com