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A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
Sponsor: Hoffmann-La Roche
Summary
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.
Official title: A Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
182
Start Date
2025-11-13
Completion Date
2030-10-30
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (56)
Profound Research, LLC
Carlsbad, California, United States
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, United States
Neurology Associates PA
Maitland, Florida, United States
University of South Florida
Tampa, Florida, United States
Johns Hopkins University School Of Medicine
Baltimore, Maryland, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Hope Neurology
Knoxville, Tennessee, United States
Swedish Medical Center
Seattle, Washington, 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
Hôpital Guillaume et René Laënnec
Nantes, France
CHU de Nimes - Hopital Universitaire Caremeau
Nîmes, France
Hopital Hautepierre - CHU Strasbourg
Strasbourg, France
Charite - Universitätsmedizin Berlin
Berlin, Germany
St. Josef-Hospital, Klinik für Neurologie
Bochum, Germany
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
Dresden, Germany
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, Germany
Universitätsklinikum Ulm
Ulm, Germany
AO.U. Policlinico Riuniti Foggia
Foggia, Apulia, Italy
AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2
Naples, Campania, Italy
Università degli studi della Campania Luigi Vanvitelli
Naples, Campania, Italy
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Rome, Lazio, Italy
NCL Institute Neuroscience
Rome, Lazio, Italy
Fond. Istituto Neurologico C.Besta
Milan, Lombardy, 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 Universitario Virgen de Arrixaca
EL Palmar (EL Palmar), Murcia, Spain
Hospital General Universitario de Albacete
Albacete, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Universitari Vall dHebron (CEMCAT)
Barcelona, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Ramon y Cajal
Madrid, Spain
Hospital Universitario Virgen Macarena
Seville, Spain