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A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis
Sponsor: Hoffmann-La Roche
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.
Official title: A Phase 1b Multicenter, Non-randomized, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Single Ascending Doses of a New Subcutaneous Formulation of Ocrelizumab in Patients With Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2024-12-17
Completion Date
2028-08-01
Last Updated
2026-06-25
Healthy Volunteers
No
Conditions
Interventions
Ocrelizumab Co-formulated With rHuPH20
Participants will receive ocrelizumab co-formulated with rHuPH20, as a SC injection, per the schedule specified in the treatment arm.
Locations (12)
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
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Morriston Hospital
Swansea, United Kingdom