Study of an On-Body Injection System for Home Use of Ocrelizumab in People with Multiple Sclerosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Immune System Diseases [C20]

Trial duration

24 Jun 2026 → ongoing

Decision date (initial)

2026-06-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann La Roche

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety

To evaluate the suitability of the on-body delivery system (OBDS) for high concentration (HC) subcutaneous (SC) ocrelizumab administration by the participant or their lay caregiver

Secondary objectives 2

1. To evaluate the suitability of OBDS for HC SC ocrelizumab administration at home
2. To evaluate the safety of OBDS + HC SC ocrelizumab

Conditions and MedDRA coding

Multiple Sclerosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age 18-65 years at the time of signing Informed Consent Form
2. Willing and able to receive injections using the OBDS, as either a self-injection or administered by a lay caregiver For participants who are willing to complete self-injection: deemed by the healthcare provider to be able to do the injection based on motor and cognitive function
3. For female participants of childbearing potential, agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 6 months after the final dose of ocrelizumab
4. For female participants without childbearing potential: Female participants may be enrolled if postmenopausal
5. Currently being treated with ocrelizumab: At least one prior dose of ocrelizumab 600 mg IV or 920 mg SC Note: The first dose of ocrelizumab in this study will be administered approximately 6 months (± 1 month) after a previous (pre-study) ocrelizumab dose (and may not be administered earlier than 5 months after the last pre-study ocrelizumab dose)
6. Diagnosis of MS according to the revised McDonald 2024 criteria (Montalban et al. 2025) or the most current published revision of the McDonald criteria at the time of study start

Exclusion criteria 6

1. Participant does not have reliable and consistent access to communication (e.g., telephone/mobile phone)
2. Participant resides in a location that, in the investigator's opinion, does not allow for timely access to an emergency medical facility
3. Pregnant or breastfeeding, or intending to become pregnant during the study or within the time frame in which contraception is required
4. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
5. Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
6. Sensitivity or intolerance to acrylic

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Occurrence of successful self/lay caregiver administration of the Week 1 dose

Secondary endpoints 5

1. Occurrence of successful self/lay caregiver administration at home of the Week 24 and Week 48 doses
2. Occurrence and nature of injection reactions (severity, treatment, need for intervention by a healthcare professional, outcome)
3. Occurrence and severity of adverse device effect (ADEs) and anticipated serious adverse device effect (ASADEs)
4. Occurrence of unanticipated serious adverse device effect (USADEs)
5. Occurrence of device deficiency (DDs) that could lead to serious adverse device effect serious adverse device effect (SADEs)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 8

Locations

4 EU/EEA countries · 24 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 39 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications