Under construction – not a live service
Sign in

2023-505975-54-00CompletedPhase 3

A Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Radiological and Clinical Effects of Subcutaneous (SC) Ocrelizumab versus Intravenous (IV) Ocrelizumab in Patients with Multiple Sclerosis

A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Radiological and Clinical Effects of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab in Patients with Multiple Sclerosis

Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Apr 2025

Next steps

Brief summary (registry, in English)

To demonstrate pharmacokinetics (PK) non-inferiority of the SC formulation of ocrelizumab in patients with MS

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
153 (actual)
First submitted
2 May 2024
Start date
28 Mar 2022
Lead sponsor
F. Hoffmann-La Roche AG
EU CT number
2023-505975-54-00
EudraCT number
2020-005448-48

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 153
  • 21 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.

Prior treatment

  • Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks prior to and during screening or treatment with oral anti microbials within 2 weeks prior to and during screening
  • Receipt of a live attenuated vaccine within 6 weeks prior to randomization

Other illness

  • History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
  • History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening

Other

  • Immunocompromised state
  • Inability to complete an MRI or contraindication to gadolinium administration

Who the study is looking for

  • Diagnosis of primary progressive MS (PPMS) or relapsing forms of MS (RMS) according to the revised McDonald 2017 criteria
  • Age 18-65 years, inclusive, at time of signing Informed Consent Form
  • Expanded disability status scale (EDSS) score, 0-6.5, inclusive, at screening
  • Neurological stability for ≥30 days prior to both screening and baseline
  • Disease duration from onset of MS symptoms of less than 15 years for patients with EDSS score <2.0 at screening
  • Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 6 months or 12 months (as applicable by the ocrelizumab IV [Ocrevus] local label) after the final dose of ocrelizumab

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (21)

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

SiteCityCountrySite status
Fakultni Nemocnice U Sv Anny V BrneBrno-StredCzechiaCompleted
Nemocnice Jihlava prispevkova organizaceJihlava 1CzechiaCompleted
Fakultni Nemocnice Hradec KraloveNovy Hradec KraloveCzechiaCompleted
Fakultni nemocnice OstravaOstravaCzechiaCompleted
Nemocnice Pardubickeho kraje a.s.PardubiceCzechiaCompleted
Fakultni nemocnice v MotolePragueCzechiaCompleted
Vseobecna Fakultni Nemocnice V PrazePrague 2CzechiaCompleted
Krajska zdravotni a.s.TepliceCzechiaCompleted
Hospital Universitari Vall d'HebronBarcelonaSpainCompleted
Hospital Universitario Reina SofiaCórdobaSpainCompleted
Hospital Universitario Puerta de Hierro de MajadahondaMajadahondaSpainCompleted
Hospital Universitario Nuestra Señora de CandelariaSanta Cruz de TenerifeSpainCompleted
Hospital Universitario Virgen De La MacarenaSevillaSpainCompleted
Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBresciaItalyCompleted
Istituto Neurologico Mediterraneo Neuromed S.p.A.PozzilliItalyCompleted
Azienda Ospedaliera Policlinico Universitario Tor VergataRomeItalyCompleted
Azienda Ospedaliero-Universitaria Sant AndreRomeItalyCompleted
Neurocentrum Bydgoszcz sp. z o.oBydgoszczPolandCompleted
Care Clinic Sp. Z O.O.KatowicePolandCompleted
Centrum Neurologii Krzysztof SelmajŁódźPolandCompleted
EMC Instytut Medyczny S.A.WroclawPolandCompleted

Are you the coordinator? Confirm the details

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