A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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
Primary outcome measure(s)
- Number of Participants With Adverse Events (AEs) — Up to 168 weeks
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Profound Research, LLC | Carlsbad | California | |
| Neurology Associates, PA | Maitland | Florida | |
| University of South Florida | Tampa | Florida | |
| Shepherd Center Inc. | Atlanta | Georgia | |
| John Hopkins University School of Medicine | Baltimore | Maryland | |
| Hope Neurology | Knoxville | Tennessee | |
| Instituto de Neurologia de Curitiba | Curitiba | Paraná | |
| Centro de Pesquisas Clinicas | São Paulo | São Paulo | |
| Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C. | Guadalajara | Jalisco | |
| Inovacion y Desarrollo en ciencias de la salud | Mexico City | Mexico CITY (federal District) | |
| Nottingham University Hospitals NHS Trust | Nottingham | United Kingdom | |
| Morriston Hospital | Swansea | United Kingdom |
More Hoffmann-La Roche trials in Brazil
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07667322 on ClinicalTrials.gov ↗ ← All trials in Brazil