A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
Start Date
11/13/2025
Completion Date
10/30/2030
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.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
Ocrelizumab Test Formulation
Ocrelizumab Reference Formulation
Conditions
Locations
Profound Research, LLC
Carlsbad, California 92011
United States
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado 80528
United States
Neurology Associates PA
Maitland, Florida 32751
United States
University of South Florida
Tampa, Florida 33612
United States
Johns Hopkins University School Of Medicine
Baltimore, Maryland 21287
United States
University of Massachusetts Medical School
Worcester, Massachusetts 01605
United States
SUNY Upstate Medical University
Syracuse, New York 13210
United States
Hope Neurology
Knoxville, Tennessee 37922
United States
Swedish Medical Center
Seattle, Washington 98104
United States
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
CABA, Buenos Aires C1424BYD
Argentina
Focus CECIC
CABA, CABA / Buenos Aires C1425BKU
Argentina
INECO Neurociencias Orono
Rosario, Santa Fe Province S2000DTC
Argentina
IME - Instituto Médico Especializado
Buenos Aires, C1405BCH
Argentina
Centro de Investigacion en Enfermedades Reumaticas CIER
Ciudad Autonoma Buenos Aires, C1055AAF
Argentina
Sanatorio del Sur S.A.
San Miguel de Tucumán, T4000IDK
Argentina
Santa Casa de Misericordia de Salvador
Salvador, Estado de Bahia 40050-410
Brazil
Freire Pesquisa Clinica
Belo Horizonte, Minas Gerais 30150
Brazil
Instituto de Neurologia de Curitiba
Curitiba, Paraná 81210-310
Brazil
Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda
Porto Alegre, Rio Grande do Sul 90110-000
Brazil
Núcleo de Pesquisa do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul 90430-001
Brazil
Instituto do Cerebro do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul 90610-000
Brazil
Clinica Neurológica e Neurocirúrgica de Joinville
Joinville, Santa Catarina 89202-165
Brazil
Centro de Pesquisas Clinicas - CPCLIN
São Paulo, São Paulo 01244-030
Brazil
Hôpital Guillaume et René Laënnec
Nantes, 44805
France
CHU de Nimes - Hopital Universitaire Caremeau
Nîmes, 30900
France
Hopital Hautepierre - CHU Strasbourg
Strasbourg, 67098
France
Charite - Universitätsmedizin Berlin
Berlin, 12203
Germany
St. Josef-Hospital, Klinik für Neurologie
Bochum, 44791
Germany
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
Dresden, 01307
Germany
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, 72076
Germany
Universitätsklinikum Ulm
Ulm, 89081
Germany
AO.U. Policlinico Riuniti Foggia
Foggia, Apulia 71100
Italy
AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2
Naples, Campania 80131
Italy
Università degli studi della Campania Luigi Vanvitelli
Naples, Campania 80138
Italy
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Rome, Lazio 00133
Italy
NCL Institute Neuroscience
Rome, Lazio 00178
Italy
Fond. Istituto Neurologico C.Besta
Milan, Lombardy 20133
Italy
IRCCS Istituto Neurologico Neuromed
Pozzilli, Molise 86077
Italy
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District) 06700
Mexico
Inovacion y Desarrollo en ciencias de la salud
Mexico City, Mexico CITY (federal District) 14090
Mexico
Neurociencias Prisma, A.C
San Luis Potosí City, San Luis Potosí 78216
Mexico
Neurociencias Estudios Clinicos S.C.
Culiacán, Sinaloa 80020
Mexico
ProNeuro Centrum Medyczne
?ory, 44-240
Poland
Neurocentrum Bydgoszcz sp z o.o
Bydgoszcz, 85-796
Poland
Centrum Neurologii Krzysztof Selmaj
Lodz, 90-324
Poland
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
Oświęcim, 32-600
Poland
Nmedis sp. z o.o.
Rzeszów, 35-323
Poland
IBISMED Wielospecjalistyczne Centrum Medyczne
Zabrze, 41-800
Poland
Hospital de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, LAS Palmas 35010
Spain
Hospital Universitario Virgen de Arrixaca
EL Palmar (EL Palmar), Murcia 30120
Spain
Hospital General Universitario de Albacete
Albacete, DUMMY_VALUE
Spain
Hospital General Universitario de Alicante
Alicante, 03010
Spain
Hospital Universitari Vall dHebron (CEMCAT)
Barcelona, 08035
Spain
Hospital Universitario de la Princesa
Madrid, 28006
Spain
Hospital Ramon y Cajal
Madrid, 28034
Spain
Hospital Universitario Virgen Macarena
Seville, 41007
Spain