A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis
Start Date
12/17/2024
Completion Date
8/1/2028
Summary
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.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
Ocrelizumab Co-formulated With rHuPH20
Conditions
Locations
Profound Research, LLC
Carlsbad, California 92011
United States
Neurology Associates, PA
Maitland, Florida 32751
United States
University of South Florida
Tampa, Florida 33612
United States
Shepherd Center Inc.
Atlanta, Georgia 30309
United States
John Hopkins University School of Medicine
Baltimore, Maryland 21287
United States
Hope Neurology
Knoxville, Tennessee 37922
United States
Instituto de Neurologia de Curitiba
Curitiba, Paraná 81210-310
Brazil
Centro de Pesquisas Clinicas
São Paulo, São Paulo 01228-200
Brazil
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
Guadalajara, Jalisco 44130
Mexico
Inovacion y Desarrollo en ciencias de la salud
Mexico City, Mexico CITY (federal District) 14090
Mexico
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
United Kingdom
Morriston Hospital
Swansea, SA6 6NL
United Kingdom