drugset / Trial / NCT07667322

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis

NCT07667322

Phase 1 Recruiting 75 enrolled Hoffmann-La Roche
NaSequentialOpen-labelTreatment

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.

Timeline

Start
2024-12-17
Primary completion
2028-02-15
Completion
2028-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ocrelizumab Monoclonal antibody Subcutaneous
Background rHuPH20 Protein / enzyme biologic Subcutaneous

Indications