A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
Trial Parameters
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Brief Summary
The main purpose of this study is to assess the bioequivalence of ocrelizumab SC test formulation to the marketed ocrelizumab SC reference formulation in participants with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The study consists of 2 phases: a controlled phase, where participants in each group will receive one dose of test or reference formulation and a continuation phase, where all participants in both groups will receive ocrelizumab SC test formulation.
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 *