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NCT07074886Active, not recruitingPhase 2

A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)

A Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis

Source: ClinicalTrials.gov · Last updated 15 Oct 2026

Brief summary (registry, in English)

The main purpose of this study is to assess the bioequivalence of ocrelizumab SC test formulation to the marketed ocrelizumab SC reference formulation in participants with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The study consists of 2 phases: a controlled phase, where participants in each group will receive one dose of test or reference formulation and a continuation phase, where all participants in both groups will receive ocrelizumab SC test formulation.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
193 (actual)
First submitted
17 Jul 2025
Start date
13 Nov 2025
Primary completion date
17 Sept 2026
Lead sponsor
Hoffmann-La Roche
NCT number
NCT07074886
EU CT number
2024-517980-22-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 193
  • From 13 Nov 2025 to the primary completion date, 17 Sept 2026
  • 54 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who have previously received anti-cluster of differentiation (CD) 20s (including ocrelizumab) less than 2 years before screening
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • Previous treatment with cladribine, atacicept, and alemtuzumab
  • Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
  • Any previous history of transplantation or anti-rejection therapy

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
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study
  • Positive screening tests for active, latent, or inadequately treated hepatitis B virus (HBV)

Lab values

  • Participants who have previously received anti-CD20s (including ocrelizumab) more than 2 years before screening if one of the following conditions is met: B-cell count is below lower limit of normal (LLN), or the discontinuation of the treatment was due to safety reasons

Other

  • Immunocompromised state
  • Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
  • Lack of peripheral venous access

Who the study is looking for

  • Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria (Thompson et al. 2018) or the most current McDonald criteria at the time of study start
  • Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (54)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Médico Rivarola IMR
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Buenos AiresArgentinaUnknown status
IME - Instituto Médico Especializado
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Buenos AiresArgentinaUnknown status
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
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CABAArgentinaUnknown status
Focus CECIC
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CABAArgentinaUnknown status
INECO Neurociencias Oroño
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RosarioArgentinaUnknown status
Sanatorio del Sur S.A.
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San Miguel de TucumánArgentinaUnknown status
Instituto de Neurologia de Curitiba
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CuritibaBrazilUnknown status
Clinica Neurologica e Neurocirurgica de Joinville
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JoinvilleBrazilUnknown status
Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda
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Porto AlegreBrazilUnknown status
Instituto do Cerebro do Rio Grande do Sul
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Porto AlegreBrazilUnknown status
Santa Casa de Misericordia de Salvador
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SalvadorBrazilUnknown status
Centro de Pesquisas Clinicas - CPCLIN
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São PauloBrazilUnknown status
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
Ruhr University
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BochumGermanyActive, not recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyActive, not recruiting
Hospital General Universitario de Albacete
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AlbaceteSpainActive, not recruiting
Hospital General Universitario Dr. Balmis
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AlicanteSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
El Hospital Universitario De Gran Canaria Dr. Negrin
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Las Palmas De Gran CanariaSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario de la Princesa
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MadridSpainActive, not recruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainActive, not recruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceActive, not recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti
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FoggiaItalyActive, not recruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyActive, not recruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyActive, not recruiting
Istituto Neurologico Mediterraneo Neuromed S.p.A.
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PozzilliItalyActive, not recruiting
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyActive, not recruiting
Neurological Centre Of Latium Istituto Di Neuroscienze O In Breve N.C.L. Istituto Di Neuroscienze S.r.l.
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RomeItalyActive, not recruiting
Neurociencias Estudios Clinicos S.C.
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CuliacánMexicoUnknown status
Inovacion y Desarrollo en ciencias de la salud
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Mexico CityMexicoUnknown status
Neurociencias PRISMA A.C.
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San Luis Potosí CityMexicoUnknown status
Neurocentrum Bydgoszcz sp. z o.o
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BydgoszczPolandActive, not recruiting
Szpital Uniwersytecki w Krakowie
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KrakowiePolandActive, not recruiting
Centrum Neurologii Krzysztof Selmaj
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ŁódźPolandActive, not recruiting
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
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OswiecimPolandActive, not recruiting
Nmedis sp. z o.o.
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RzeszówPolandActive, not recruiting
IBISMED Wielospecjalistyczne Centrum Medyczne
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ZabrzePolandActive, not recruiting
ProNeuro Centrum Medyczne
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ZoryPolandActive, not recruiting
Johns Hopkins University School Of Medicine
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BaltimoreUnited StatesUnknown status
Profound Research LLC
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CarlsbadUnited StatesUnknown status
Advanced Neurology of Colorado, LLC
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Fort CollinsUnited StatesUnknown status
Hope Neurology
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KnoxvilleUnited StatesUnknown status
Neurology Associates PA
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MaitlandUnited StatesUnknown status
Swedish Medical Center
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SeattleUnited StatesUnknown status
SUNY Upstate Medical University
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SyracuseUnited StatesUnknown status
University of South Florida
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TampaUnited StatesUnknown status
University of Massachusetts Medical School
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WorcesterUnited StatesUnknown status

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