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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

Next steps

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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (24)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Universitari Vall d'HebronBarcelonaSpainActive, not recruiting
Hospital Universitario de la PrincesaMadridSpainActive, not recruiting
Hospital Universitario Ramón y CajalMadridSpainActive, not recruiting
University Clinical Hospital Virgen De La ArrixacaMurciaSpainActive, not recruiting
Hospital Universitario Quironsalud MadridPozuelo de AlarcónSpainActive, not recruiting
Hospital Universitario Virgen De La MacarenaSevillaSpainActive, not recruiting
Hospital Hotel DieuNantesFranceActive, not recruiting
Centre Hospitalier National d'Ophtalmologie des Quize-VingtsParisFranceActive, not recruiting
Centre Hospitalier Universitaire de ToulouseToulouseFranceActive, not recruiting
Centre Hospitalier ValenceValenceFranceActive, not recruiting
Fondazione Istituto G. Giglio Di CafaluCefalu'ItalyActive, not recruiting
Azienda Ospedaliero Universitaria Ospedali RiunitiFoggiaItalyActive, not recruiting
Ospedale San Raffaele S.r.l.MilanItalyActive, not recruiting
Azienda Ospedaliera Universitaria Federico II Di NapoliNaplesItalyActive, not recruiting
Neurological Centre Of Latium Istituto Di Neuroscienze O In Breve N.C.L. Istituto Di Neuroscienze S.r.l.RomeItalyActive, not recruiting
Azienda Ospedaliera Policlinico Universitario Tor VergataRomeItalyActive, not recruiting
Neurocentrum Bydgoszcz sp. z o.oBydgoszczPolandActive, not recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracowPolandActive, not recruiting
Care Clinic Sp. Z O.O.KatowicePolandActive, not recruiting
Resmedica Sp. z o.o.KielcePolandActive, not recruiting
Centrum Neurologii Krzysztof SelmajŁódźPolandActive, not recruiting
Indywidualna Praktyka Lekarska Prof. Dr hab Konrad RejdakLublinPolandActive, not recruiting
Nmedis sp. z o.o.RzeszówPolandActive, not recruiting
IBISMED Wielospecjalistyczne Centrum MedyczneZabrzePolandActive, not recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.