2025-523726-40-00Active, not recruitingPhase 3
Study of an On-Body Injection System for Home Use of Ocrelizumab in People with Multiple Sclerosis
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 27 Feb 2026
- Start date
- 24 Jun 2026
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Multiple sclerosis
- EU CT number
- 2025-523726-40-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 54
- 24 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
Other
- Participant does not have reliable and consistent access to communication (e.g., telephone/mobile phone)
- Participant resides in a location that, in the investigator's opinion, does not allow for timely access to an emergency medical facility
- Pregnant or breastfeeding, or intending to become pregnant during the study or within the time frame in which contraception is required
- Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
- Sensitivity or intolerance to acrylic
Who the study is looking for
- Age 18-65 years at the time of signing Informed Consent Form
- 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
- 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
- For female participants without childbearing potential: Female participants may be enrolled if postmenopausal
- 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)
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario de la Princesa | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal | Madrid | Spain | Active, not recruiting |
| University Clinical Hospital Virgen De La Arrixaca | Murcia | Spain | Active, not recruiting |
| Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena | Sevilla | Spain | Active, not recruiting |
| Hospital Hotel Dieu | Nantes | France | Active, not recruiting |
| Centre Hospitalier National d'Ophtalmologie des Quize-Vingts | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Toulouse | Toulouse | France | Active, not recruiting |
| Centre Hospitalier Valence | Valence | France | Active, not recruiting |
| Fondazione Istituto G. Giglio Di Cafalu | Cefalu' | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Ospedali Riuniti | Foggia | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli | Naples | Italy | Active, not recruiting |
| Neurological Centre Of Latium Istituto Di Neuroscienze O In Breve N.C.L. Istituto Di Neuroscienze S.r.l. | Rome | Italy | Active, not recruiting |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata | Rome | Italy | Active, not recruiting |
| Neurocentrum Bydgoszcz sp. z o.o | Bydgoszcz | Poland | Active, not recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie | Cracow | Poland | Active, not recruiting |
| Care Clinic Sp. Z O.O. | Katowice | Poland | Active, not recruiting |
| Resmedica Sp. z o.o. | Kielce | Poland | Active, not recruiting |
| Centrum Neurologii Krzysztof Selmaj | Łódź | Poland | Active, not recruiting |
| Indywidualna Praktyka Lekarska Prof. Dr hab Konrad Rejdak | Lublin | Poland | Active, not recruiting |
| Nmedis sp. z o.o. | Rzeszów | Poland | Active, not recruiting |
| IBISMED Wielospecjalistyczne Centrum Medyczne | Zabrze | Poland | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.