Safety and Feasibility of Home Use On-Body Injection System for Subcutaneous Ocrelizumab in Adults with Multiple Sclerosis

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What is this study about?

Multiple Sclerosis is a condition in which the body’s immune system mistakenly attacks the protective covering of nerve fibers, leading to problems with movement, vision, and feeling. The study uses the medicine Ocrelizumab, which is given as a high‑concentration injection under the skin (subcutaneous) using a small device that can be worn on the body.

The purpose of the study is to see whether the on‑body delivery system can be safely and effectively used by patients or a non‑medical caregiver at home.

Participants will receive the first dose at home during the first week, followed by additional doses around the 24‑week and 48‑week marks. Throughout the study, the occurrence of any problems with the injection, such as redness, swelling, or pain (known as injection reactions), and any issues related to the device itself will be recorded and managed as needed.

1 initial training on the on-body delivery system

receive instruction on how to attach and operate the on-body delivery system, a device that holds the medication and delivers it under the skin.

learn how to check that the device is working correctly and how to record any problems.

2 preparation for the first dose (week 1)

ensure the device is loaded with the medication ocrelizumab as supplied by the study team.

verify that the medication is a solution for injection intended for subcutaneous injection, which means it will be placed just under the skin.

3 self‑administration or caregiver administration of week 1 dose

administer the dose of ocrelizumab using the on-body delivery system according to the instructions.

the dose amount is determined by the study protocol and is delivered as a single subcutaneous injection.

4 post‑injection monitoring after week 1 dose

observe the injection site for any reactions such as redness, swelling, or pain.

record any symptoms or device issues and report them according to the study instructions.

5 preparation for the second dose (week 24)

repeat the device check and loading procedure using the new supply of ocrelizumab.

confirm that the device is ready for the subcutaneous injection.

6 self‑administration or caregiver administration of week 24 dose

administer the second dose of ocrelizumab with the on-body delivery system in the same manner as the first dose.

7 post‑injection monitoring after week 24 dose

watch for injection reactions or device problems and document any findings.

8 preparation for the third dose (week 48)

perform the device and medication check again using the final supply of ocrelizumab.

9 self‑administration or caregiver administration of week 48 dose

give the third dose of ocrelizumab with the on-body delivery system as instructed.

10 final monitoring and study completion

continue to observe the injection site and overall health for any delayed reactions.

complete all required documentation and return the device according to the study guidelines.

Who Can Join the Study?

Age: You must be between 18 and 65 years old when you sign the consent form.
Injection method: You must be willing and able to receive the medication using the on‑body delivery system (OBDS). This can be done by you yourself (self‑injection) or by a non‑medical caregiver (a lay caregiver). If you choose self‑injection, your doctor must decide that you have enough movement ability (motor function) and thinking ability (cognitive function) to give the shot safely.
Female participants who could become pregnant (childbearing potential): You must agree to either avoid heterosexual intercourse (remain abstinent) or use reliable birth control (contraception) during the treatment period and for six months after the last dose.
Female participants who cannot become pregnant (no childbearing potential): You may join the study if you are postmenopausal, meaning your menstrual periods have stopped naturally.
Current use of ocrelizumab: You must already be receiving the medication ocrelizumab and have had at least one previous dose of 600 mg given through a vein (IV) or 920 mg given under the skin (SC). The first study dose will be given about six months (± 1 month) after your last pre‑study ocrelizumab dose and cannot be given earlier than five months after that dose.
Diagnosis of multiple sclerosis (MS): You must have a confirmed diagnosis of MS based on the most recent version of the McDonald criteria (the guidelines doctors use to diagnose MS).

Who Cannot Join the Study?

Does not have reliable and consistent access to communication such as a telephone or mobile phone.
Lives in a location that, in the investigator’s opinion, does not allow timely access to an emergency medical facility.
Is pregnant, breastfeeding, or plans to become pregnant during the study or while birth control is required.
Has a history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (lab‑made proteins that target specific parts of the immune system).
Has sensitivity or intolerance to any ingredient, including excipients (inactive substances used in the medication) of ocrelizumab.
Has sensitivity or intolerance to acrylic (a type of plastic material used in the device).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione Istituto G. Giglio Di Cafalu	Cefalu'	Italy
Nnissorfnebv Cvzfpi Ox Lxxwak Isvenvrx Dx Nhwljhshjxha O In Bbiyz Nogdcw Iblmxxgg Dl Ngmhcyhqokuh Siclxk	Rome	Italy
Axjabln Oqpwogfmkmn Unzsztynoixlq Oomshtrv Rhnwhhn	Foggia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	16.06.2026

Trial locations

Investigated drugs:

Ocrelizumab

Ocrevus (ocrelizumab) is a medication that helps control the immune system in people with multiple sclerosis. It works by targeting specific cells that cause inflammation and damage to the nerves. In this study, participants receive the medication under the skin using a special delivery method, which allows them to give the treatment at home instead of visiting a clinic.

The on-body delivery system (OBDS) is a small, wearable device that holds a high‑concentration form of the medication and automatically delivers it through the skin. It is designed so that patients or a non‑medical caregiver can safely give the injection themselves, making treatment more convenient and reducing the need for frequent clinic visits.

Multiple Sclerosis – Multiple Sclerosis is a condition where the immune system mistakenly attacks the protective covering of nerves in the brain and spinal cord. This damage disrupts the normal flow of nerve signals, causing muscle weakness, numbness, and coordination difficulties. Symptoms often appear in episodes that may improve and then return, or they can become more steady over time. The disease usually begins with mild signs and can slowly involve more parts of the body as the nerve covering continues to be damaged.

Trial ID:

2025-523726-40-00

Protocol code:

CN46182

Trial Phase:

Therapeutic confirmatory (Phase III)

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Safety and Feasibility of Home Use On-Body Injection System for Subcutaneous Ocrelizumab in Adults with Multiple Sclerosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?