A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)

Launched by HOFFMANN-LA ROCHE · Jul 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different versions of a medicine called ocrelizumab, given as a shot under the skin, to see if they work the same way in people with multiple sclerosis (MS). MS is a condition that affects the nerves in the brain and spinal cord. The study includes people with two types of MS: relapsing MS, where symptoms come and go, and primary progressive MS, where symptoms gradually get worse over time. The trial has two parts: first, participants will receive one dose of either the new version or the usual version of ocrelizumab, and then everyone will continue receiving the new version.

People who might join this study need to have a confirmed diagnosis of one of these types of MS and a certain level of disability that is not too severe. They should not have had certain treatments recently or have other serious health problems like cancer, infections, or immune system issues. Participants can expect to receive medicine as a shot and be monitored closely throughout the study. This trial has not started recruiting yet, but it offers a chance for people with MS to help researchers learn if a new form of ocrelizumab works just as well and is safe.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria (Thompson et al. 2018) or the most current McDonald criteria at the time of study start
• • Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening
• Exclusion Criteria:
• • Participants who have previously received anti-cluster of differentiation (CD)20s (including ocrelizumab) less than 2 years before screening
• • Participants who have previously received anti-CD20s (including ocrelizumab) more than 2 years before screening if one of the following conditions is met: B-cell count is below lower limit of normal (LLN), or the discontinuation of the treatment was due to safety reasons
• • History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
• • History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
• • Immunocompromised state
• • Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
• • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
• • Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study
• • Lack of peripheral venous access
• • Previous treatment with cladribine, atacicept, and alemtuzumab
• • Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
• • Any previous history of transplantation or anti-rejection therapy
• • Positive screening tests for active, latent, or inadequately treated hepatitis B virus (HBV)