A Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 182 participants

Interventions

• DRUG: Ocrelizumab Test Formulation — Ocrelizumab test formulation will be administered as per the schedule specified in the respective arm.
• DRUG: Ocrelizumab Reference Formulation — Ocrelizumab reference formulation will be administered as per the schedule specified in the respective arm.

Primary Outcomes

• Area Under the Serum Concentration-time Curve Over the First 12 Weeks Post-dose (AUC0-12W) of Ocrelizumab (Up to 12 weeks)
• Maximum Serum Concentration (Cmax) of Ocrelizumab (Up to 12 weeks)

Secondary Outcomes

• Number of Participants With Adverse Events (AEs) (Up to 168 weeks)

Trial Locations

• Profound Research, LLC, Carlsbad, California, United States
• Advanced Neurology of Colorado, LLC, Fort Collins, Colorado, United States
• Neurology Associates PA, Maitland, Florida, United States
• University of South Florida, Tampa, Florida, United States
• Johns Hopkins University School Of Medicine, Baltimore, Maryland, United States
• University of Massachusetts Medical School, Worcester, Massachusetts, United States
• SUNY Upstate Medical University, Syracuse, New York, United States
• Hope Neurology, Knoxville, Tennessee, United States
• Swedish Medical Center, Seattle, Washington, United States
• Centro de Especialidades Neurológicas y Rehabilitación - CENyR, CABA, Buenos Aires, Argentina
• ...and 10 more locations

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