Phase III Open‑Label Single‑Arm Multicenter Study of On‑Body Delivery System for Subcutaneous High‑Concentration Ocrelizumab in Adults with Multiple Sclerosis

The primary objective is to assess the suitability of the Multiple Sclerosis patient‑ or caregiver‑administered on‑body delivery system (OBDS) for high‑concentration subcutaneous ocrelizumab, establishing whether the device enables reliable home injection. This evaluation is clinically relevant because it may expand access to disease‑modifying therapy and reduce the need for in‑clinic infusion visits. Secondary objectives include:

• Evaluation of the OBDS’s suitability for high‑concentration subcutaneous ocrelizumab administration in the home setting.
• Assessment of the safety profile of the combined OBDS and high‑concentration subcutaneous ocrelizumab regimen.

The study enrolled 96 participants with a confirmed diagnosis of Multiple Sclerosis according to the revised McDonald criteria, all of whom had previously received at least one dose of ocrelizumab (600 mg IV or 920 mg SC) and were scheduled to receive the first study dose approximately six months after the prior infusion. Eligible individuals were aged 18–65 years at consent, included both males and females, and were required to be in generally stable health allowing subcutaneous administration via an on‑body delivery system either by self‑injection or a lay caregiver. Inclusion required sufficient motor and cognitive function for self‑injection, and female participants of childbearing potential had to agree to use effective contraception or abstain during treatment and for six months thereafter; post‑menopausal women were also eligible. The population comprised patients considered vulnerable due to the chronic nature of their condition, but no additional lifestyle restrictions such as specific diet or activity levels were stipulated.

The study is an open‑label, single‑arm Phase III trial evaluating the suitability of an on‑body delivery system (OBDS) for high‑concentration subcutaneous administration of ocrelizumab in participants with Multiple Sclerosis. Eligible adults (18–65 years) who have received at least one prior dose of ocrelizumab (600 mg IV or 920 mg SC) and meet the revised McDonald criteria are enrolled. After a screening visit to confirm eligibility, participants receive the first OBDS dose at Week 1, followed by additional home‑administered doses at Week 24 and Week 48. Follow‑up visits are scheduled at each dosing time point to assess administration success, injection‑site reactions, adverse device effects, and device deficiencies. An end‑of‑study visit occurs after the Week 48 dose to collect final safety and device performance data. Participant involvement spans approximately 48 weeks of active treatment plus a short post‑treatment observation period. Primary efficacy is the occurrence of successful self‑ or lay‑caregiver administration of the Week 1 dose; secondary outcomes include successful administration at Weeks 24 and 48, characterization of injection reactions, severity of adverse device effects (including anticipated, serious, and unanticipated), and any device deficiencies that could lead to serious adverse events. Early termination may occur for any participant experiencing severe adverse events, device malfunction that compromises safety, inability to perform self‑injection or receive caregiver assistance, or non‑compliance with protocol requirements. Recruitment began on 16 June 2026 and the study is planned to conclude on 25 May 2028.

The investigational product is Ocrevus (Ocrelizumab), supplied as a solution for injection intended for subcutaneous injection. The preparation is a high‑concentration formulation designed for administration using an on‑body delivery system (OBDS) that permits home self‑administration by the participant or a lay caregiver. Dosing follows the study‑specific schedule and is delivered via the OBDS according to the protocol‑defined intervals.

No comparator, placebo, or standard‑of‑care therapy is administered in this single‑arm study; participants receive only the investigational product.

Administration is performed by the participant or caregiver under remote monitoring. The OBDS records injection events and timestamps, which are reviewed regularly to assess adherence. Participants receive training on device operation, injection technique, and documentation of any dosing deviations.