The main purpose of this study is to evaluate the safety and tolerability of the ocrelizumab subcutaneous (SC) test formulation in participants with multiple sclerosis (MS). The study consists of two treatment phases: a dose-escalation and dose-continuation phase. Participants will receive single ascending doses of ocrelizumab SC during an initial dose-escalation phase, with the option to continue treatment with the selected dose of ocrelizumab SC in the dose-continuation phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Participants will receive ocrelizumab co-formulated with rHuPH20, as a SC injection, per the schedule specified in the treatment arm.
Profound Research, LLC
Carlsbad, California, United States
Neurology Associates, PA
Maitland, Florida, United States
University of South Florida
Tampa, Florida, United States
Shepherd Center Inc.
Atlanta, Georgia, United States
John Hopkins University School of Medicine
Baltimore, Maryland, United States
Hope Neurology
Knoxville, Tennessee, United States
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil
Centro de Pesquisas Clinicas
São Paulo, São Paulo, Brazil
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
Guadalajara, Jalisco, Mexico
Inovacion y Desarrollo en ciencias de la salud
Mexico City, Mexico CITY (federal District), Mexico
...and 2 more locations
Number of Participants With Adverse Events (AEs)
Time frame: Up to 168 weeks
Ocrelizumab Serum Concentration at Specified Timepoints Following Single SC Administration
Time frame: Up to 168 weeks
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs) to Ocrelizumab
Time frame: Up to 168 weeks
Number of Participants With Treatment-emergent ADAs to rHuPH20
Time frame: Up to 168 weeks
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