RecruitingPhase 2NCT07074886

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

Sponsor

Hoffmann-La Roche

Enrollment

182 participants

Start Date

Nov 13, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different under-the-skin (subcutaneous) injection formulations of ocrelizumab — a treatment for multiple sclerosis — to confirm they are absorbed by the body in the same way. **You may be eligible if...** - You have a confirmed diagnosis of relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) - Your disability level (EDSS score) is between 0 and 6.5 **You may NOT be eligible if...** - You have received any anti-CD20 therapy (including ocrelizumab) within the past 2 years - You received anti-CD20 therapy more than 2 years ago AND your B-cell counts are still below normal, OR you stopped it due to safety concerns - You have a history of a serious brain infection called PML (progressive multifocal leukoencephalopathy) - You have other disqualifying conditions based on the study's safety criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOcrelizumab Test Formulation

Ocrelizumab test formulation will be administered as per the schedule specified in the respective arm.

DRUGOcrelizumab 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

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NCT07074886

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