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

Condition studied

Multiple Sclerosis (MS)

Investigational medicinal product(s)

Eligibility

Primary endpoint

The primary PK parameters of ocrelizumab: area under the serum concentration−time curve over the first 12 weeks post-dose (AUC0-12W) and maximum serum concentration observed (Cmax)

Endpoint detail

Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 grading scale, Change from baseline in selected vital signs, Change from baseline in selected clinical laboratory test results