A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Genentech, Inc.
- Study ID
- NCT07609719
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- OCR SC — DRUGParticipants will receive OCR SC as per the schedule specified in the arm and the United States Prescribing Information (USPI).
Study Details
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).
Key Dates
- Start date
- Jul 15, 2026
- Status verified
- May 2026
- Primary completion
- Feb 28, 2029
- Completion
- Feb 28, 2029
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: OCR SCParticipants will receive OCR SC, 920 milligrams (mg) at Day 1 and at Week 24.
Primary Outcome Measure
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 [ Time Frame: Baseline, Week 24 ]
Central Contacts
- Reference Study ID Number: ML46740 https://forpatients.roche.com/888-662-6728 (U.S.)
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Alabama Neurology Associates | Birmingham | Alabama | 35209 | - |
| Clinical Endpoints | Scottsdale | Arizona | 85258 | - |
| Advanced Neurology of Colorado | Fort Collins | Colorado | 80528 | - |
| Neurology Associates - Maitland | Orlando | Florida | 32751 | - |
| Multiple Sclerosis Center of Atlanta/Atlanta Neuroscience Institute | Atlanta | Georgia | 30327 | - |
| Minneapolis Clinic of Neurology | Minneapolis | Minnesota | 55422 | - |
| Ohio State University, Multiple Sclerosis and Neuroimmunology Center | Columbus | Ohio | 43210 | - |
| Neurology Clinic, P.C. | Cordova | Tennessee | 38018 | - |
| DHR Health MS Center | McAllen | Texas | 78501 | - |
| MultiCare Institute for Research & Innovation | Tacoma | Washington | 98405 | - |
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