A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
A Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis
About This Trial
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Ocrelizumab Test Formulation
Ocrelizumab test formulation will be administered as per the schedule specified in the respective arm.
Ocrelizumab Reference Formulation
Ocrelizumab reference formulation will be administered as per the schedule specified in the respective arm.