🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT07609719
Recruiting Phase 4

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

NCT07609719 · tracked via the Priya Life Science USA tracker
Sponsor
Genentech, Inc.
Phase
Phase 4
Started
2026-09-02
Last updated
2026-09-08

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

OCR SC

OCR SC: Participants will receive OCR SC as per the schedule specified in the arm and the United States Prescribing Information (USPI).

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Atlanta Neuroscience Institute Atlanta Georgia Recruiting
Neurology Clinic PC Cordova Tennessee Recruiting
Caribbean Center for Clinical Research Guaynabo Puerto Rico Recruiting

More Genentech, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07609719 on ClinicalTrials.gov ↗ ← All trials in the USA