CN46182 - STUDY OF AN ON-BODY INJECTION SYSTEM FOR HOME USE OF OCRELIZUMAB IN PEOPLE WITH MS
Research type
Research Study
Full title
A Phase III, Open-Label, Single-Arm, Multi-Center Study to Evaluate the Safety and Use of an On-Body Delivery System for the Subcutaneous Home Administration of Ocrelizumab in Patients with Multiple Sclerosis
IRAS ID
1013623
Contact name
N/A N/A
Contact email
Sponsor organisation
F. Hoffmann-La Roche AG
Clinicaltrials.gov Identifier
Research summary
Multiple sclerosis(MS)is a long-lasting disease affecting the central nervous system. It causes inflammation&damage to protective covering of nerve fibers, leading to problems with communication between the brain & the rest of the body.MS can result in symptoms like muscle weakness, difficulty walking & problems with vision. There are different types of MS, including relapsing-remitting(RMS), secondary progressive&primary progressive(PPMS), each with varying patterns of symptoms&progression.
This study will testing a medicine called ocrelizumab & evaluate the suitability of the enFuseTM Vial Transfer System, also known as the on-body delivery system(OBDS), for safe self-administration or lay caregiver administration of a new, high concentration(HC)subcutaneous(SC) Ocrelizumab every 6 months by patients with MS. The primary objective is to assess whether patients with MS or their lay caregivers can use the OBDS successfully in the home setting.
Ocrelizimab is approved for treating RMS or PPMS as an intravenous(IV)infusion or as an SC injection every 6 months.The new HCSC ocrelizumab formulation is ready-to-use & could allow patient or lay caregiver administration at home using an OBDS without requiring direct observation by a healthcare provider. This approach shifts the point of care from the clinic to the home, potentially improving patient’s treatment adherence&quality of life. The study assumes that patients currently treated with ocrelizumab can safely transition to at-home administration after appropriate training. To validate this assumption, the protocol incorporates several key safety measures & structured follow-up calls and visits to monitor safety&device performance.
150 people with MS will be recruited globally with 20 at 6 UK sites
The study will last approximately 18 months for each individual with all participants expected to be recruited by Dec 2026.
The study is sponsored by F. Hoffmann- La Roche
Research Summary; Version 1 dated 04Mar2026REC name
East of England - Cambridge East Research Ethics Committee
REC reference
26/EE/0119
Date of REC Opinion
19 Jun 2026
REC opinion
Further Information Favourable Opinion