A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
NCT ID: NCT07074886
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
182 participants
INTERVENTIONAL
2025-11-13
2030-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ocrelizumab Test Formulation
Participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the controlled phase and continuation phase.
Ocrelizumab Test Formulation
Ocrelizumab test formulation will be administered as per the schedule specified in the respective arm.
Ocrelizumab Reference Formulation
Participants will receive ocrelizumab reference formulation, 920 mg, as SC injection, on Day 1 during the controlled phase. Thereafter, participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the continuation phase.
Ocrelizumab Test Formulation
Ocrelizumab test formulation will be administered as per the schedule specified in the respective arm.
Ocrelizumab Reference Formulation
Ocrelizumab reference formulation will be administered as per the schedule specified in the respective arm.
Interventions
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Ocrelizumab Test Formulation
Ocrelizumab test formulation will be administered as per the schedule specified in the respective arm.
Ocrelizumab Reference Formulation
Ocrelizumab reference formulation will be administered as per the schedule specified in the respective arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening
Exclusion Criteria
* 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
* History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
* History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
* Immunocompromised state
* Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
* Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study
* Lack of peripheral venous access
* 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
* Positive screening tests for active, latent, or inadequately treated hepatitis B virus (HBV)
18 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Profound Research, LLC
Carlsbad, California, United States
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, United States
Neurology Associates PA
Maitland, Florida, United States
Hope Neurology
Knoxville, Tennessee, United States
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
CABA, Buenos Aires, Argentina
Focus CECIC
CABA, CABA / Buenos Aires, Argentina
INECO Neurociencias Orono
Rosario, Santa Fe Province, Argentina
IME - Instituto Médico Especializado
Buenos Aires, , Argentina
Centro de Investigacion en Enfermedades Reumaticas CIER
Ciudad Autonoma Buenos Aires, , Argentina
Sanatorio del Sur S.A.
San Miguel de Tucumán, , Argentina
Santa Casa de Misericordia de Salvador
Salvador, Estado de Bahia, Brazil
Freire Pesquisa Clinica
Belo Horizonte, Minas Gerais, Brazil
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil
Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda
Porto Alegre, Rio Grande do Sul, Brazil
Núcleo de Pesquisa do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Instituto do Cerebro do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Clinica Neurológica e Neurocirúrgica de Joinville
Joinville, Santa Catarina, Brazil
Centro de Pesquisas Clinicas - CPCLIN
São Paulo, São Paulo, Brazil
CHU de Nimes - Hopital Universitaire Caremeau
Nîmes, , France
Hôpital Guillaume et René Laënnec
Saint-Herblain, , France
Hopital Hautepierre - CHU Strasbourg
Strasbourg, , France
AO.U. Policlinico Riuniti Foggia
Foggia, Apulia, Italy
NCL Institute Neuroscience
Rome, Lazio, Italy
IRCCS Istituto Neurologico Neuromed
Pozzilli, Molise, Italy
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District), Mexico
Inovacion y Desarrollo en ciencias de la salud
Mexico City, Mexico CITY (federal District), Mexico
Neurociencias Prisma, A.C
San Luis Potosí City, San Luis Potosí, Mexico
Neurociencias Estudios Clinicos S.C.
Culiacán, Sinaloa, Mexico
ProNeuro Centrum Medyczne
?ory, , Poland
Neurocentrum Bydgoszcz sp z o.o
Bydgoszcz, , Poland
Centrum Neurologii Krzysztof Selmaj
Lodz, , Poland
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
Oświęcim, , Poland
Nmedis sp. z o.o.
Rzeszów, , Poland
IBISMED Wielospecjalistyczne Centrum Medyczne
Zabrze, , Poland
Hospital de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, LAS Palmas, Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Countries
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Central Contacts
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Reference Study ID Number: CN45320 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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2024-517980-22-00
Identifier Type: CTIS
Identifier Source: secondary_id
CN45320
Identifier Type: -
Identifier Source: org_study_id
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