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

NCT07609719 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: ML46740
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 11

Brief 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).

Conditions

Multiple Sclerosis

Keywords

Primary Progressive Multiple Sclerosis; Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, Week 24

Secondary Outcomes (10)

• Percentage of Participants With no New or Enlarging T2 Lesions as Detected by Brain MRI at Week 24

  At Week 24

• Number of Participants With Adverse Events (AEs)

  Up to Week 48

• Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gd+ Lesions as Detected by Brain MRI at Week 48

  Baseline, Week 48

• Percentage of Participants With no New or Enlarging T2 Lesions as Detected by Brain MRI at Week 48

  At Week 48

• Change From Baseline in Cluster of Differentiation 19 (CD19+) B-cell Counts at Week 24 and Week 48

  Baseline, Weeks 24 and 48

Study Arms (1)

OCR SC

EXPERIMENTAL

Participants will receive OCR SC, 920 milligrams (mg) at Day 1 and at Week 24.

Drug: OCR SC

Interventions

OCR SC DRUG

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

Also known as: Ocrevus Zunovo® USPI;, RO4964913

OCR SC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 after starting aCD20 therapy, 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (11)

Alabama Neurology Associates

Birmingham, Alabama, 35209, United States

Location

Clinical Endpoints

Scottsdale, Arizona, 85258, United States

Location

Advanced Neurology of Colorado

Fort Collins, Colorado, 80528, United States

Location

Neurology Associates - Maitland

Orlando, Florida, 32751, United States

Location

Multiple Sclerosis Center of Atlanta/Atlanta Neuroscience Institute

Atlanta, Georgia, 30327, United States

Location

Minneapolis Clinic of Neurology

Minneapolis, Minnesota, 55422, United States

Location

Ohio State University, Multiple Sclerosis and Neuroimmunology Center

Columbus, Ohio, 43210, United States

Location

Neurology Clinic, P.C.

Cordova, Tennessee, 38018, United States

Location

DHR Health MS Center

McAllen, Texas, 78501, United States

Location

MultiCare Institute for Research & Innovation

Tacoma, Washington, 98405, United States

Location

Caribbean Center for Clinical Research

Guaynabo, 00968, Puerto Rico

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: ML46740 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S.); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

PR (1); US (10)