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NCT07074886PHASE2Recruiting

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

Hoffmann-La Roche

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

Inclusion Criteria: * 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 Exclusion Criteria: * Participants who have previously received anti-cluster of differentiation (CD) 20s (including ocrelizumab) less than 2 years before screening * 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)

Interventions

DRUG

Ocrelizumab Test Formulation

DRUG

Ocrelizumab Reference Formulation

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Conditions

Multiple Sclerosis

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