Subcutaneous Ocrelizumab for Multiple Sclerosis

(OCARINA 3 Trial)

This trial tests a new method of administering ocrelizumab, a medication for multiple sclerosis (MS), to evaluate its safety and how the body processes it. The trial consists of two phases: one tests different doses, and the other administers a selected dose over time. Individuals with primary progressive or relapsing MS who have not used similar treatments in the past two years may qualify. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to experience this new approach.

Research has shown that the under-the-skin (subcutaneous) form of ocrelizumab is generally well-tolerated by people with multiple sclerosis. In one study, only 2.6% of patients who received the injection experienced serious side effects, indicating that most do not have severe reactions. The safety of this subcutaneous form is similar to the IV (intravenous) form that doctors have used for some time, suggesting it is likely just as safe. Another study found no safety issues, even when antibodies to a protein called rHuPH20, which aids absorption, were present. Overall, the treatment appears safe for people with multiple sclerosis.¹²³⁴⁵

Unlike the standard of care for multiple sclerosis, which typically involves intravenous infusions, ocrelizumab co-formulated with rHuPH20 is delivered subcutaneously. This delivery method is less invasive and can be more convenient for patients, potentially improving adherence to treatment. Researchers are excited about this approach because it combines ocrelizumab, a proven therapy for multiple sclerosis, with recombinant human hyaluronidase (rHuPH20), which enhances the absorption and distribution of the medication. This could lead to more efficient treatment with fewer side effects.

Research has shown that subcutaneous ocrelizumab, which participants in this trial will receive, effectively treats multiple sclerosis (MS). Studies indicate that this form of ocrelizumab can almost completely prevent the return of symptoms and the development of brain lesions in MS patients. It also slows the worsening of disability in people with relapsing MS, helping them maintain their physical abilities longer. Additionally, subcutaneous injections of ocrelizumab are as effective as the intravenous (IV) form in managing brain lesions seen on MRI scans. Overall, patients report high satisfaction with the treatment, and it is well-tolerated with no major safety concerns.¹⁴⁵⁶⁷