Phase 1b Evaluation of a New Subcutaneous Ocrelizumab Formulation in Adults with Multiple Sclerosis to Assess Safety and Effects

What this Trial Is About

Researchers are evaluating a new subcutaneous formulation of ocrelizumab for adults with multiple sclerosis MS. This Phase 1b study focuses on assessing the safety and tolerability of this formulation in participants diagnosed with primary progressive or relapsing MS. The trial aims to better understand how the drug behaves in the body and its immune response effects over time. Participants will first enter a dose-escalation phase lasting 24 weeks, during which they will receive single ascending doses of ocrelizumab combined with recombinant human hyaluronidase rHuPH20 as a subcutaneous injection. Those who choose to continue will enter a dose-continuation phase, receiving the selected dose every 24 weeks for up to 144 weeks, totaling a possible 168 weeks of treatment exposure. Throughout the study, participants will undergo regular safety monitoring for adverse events and immune response, including blood tests to measure drug levels and antibodies against ocrelizumab and rHuPH20. The main outcome is the number of participants experiencing adverse events during the study. The total duration of participation may extend up to 168 weeks, with ongoing evaluations to assess tolerability and the bodys response to the treatment over time.

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