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

NCT07074886 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: CN453202024-517980-22-00
• Study Type: interventional
• Target: 182
• Locations: 9 countries
• Sites: 56

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Area Under the Serum Concentration-time Curve Over the First 12 Weeks Post-dose (AUC0-12W) of Ocrelizumab

  Up to 12 weeks

• Maximum Serum Concentration (Cmax) of Ocrelizumab

  Up to 12 weeks

Secondary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  Up to 168 weeks

Study Arms (2)

Ocrelizumab Test Formulation

EXPERIMENTAL

Participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the controlled phase and continuation phase.

Drug: Ocrelizumab Test Formulation

Ocrelizumab Reference Formulation

ACTIVE COMPARATOR

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.

Drug: Ocrelizumab Test Formulation; Drug: Ocrelizumab Reference Formulation

Interventions

Ocrelizumab Test Formulation DRUG

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

Also known as: RO4964913

Ocrelizumab Reference Formulation; Ocrelizumab Test Formulation

Ocrelizumab Reference Formulation DRUG

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

Also known as: RO4964913

Ocrelizumab Reference Formulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (56)

Profound Research, LLC

Carlsbad, California, 92011, United States

RECRUITING

Advanced Neurology of Colorado, LLC

Fort Collins, Colorado, 80528, United States

RECRUITING

Neurology Associates PA

Maitland, Florida, 32751, United States

RECRUITING

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

Johns Hopkins University School Of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

University of Massachusetts Medical School

Worcester, Massachusetts, 01605, United States

RECRUITING

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

RECRUITING

Hope Neurology

Knoxville, Tennessee, 37922, United States

RECRUITING

Swedish Medical Center

Seattle, Washington, 98104, United States

RECRUITING

Centro de Especialidades Neurológicas y Rehabilitación - CENyR

CABA, Buenos Aires, C1424BYD, Argentina

RECRUITING

Focus CECIC

CABA, CABA / Buenos Aires, C1425BKU, Argentina

RECRUITING

INECO Neurociencias Orono

Rosario, Santa Fe Province, S2000DTC, Argentina

RECRUITING

IME - Instituto Médico Especializado

Buenos Aires, C1405BCH, Argentina

RECRUITING

Centro de Investigacion en Enfermedades Reumaticas CIER

Ciudad Autonoma Buenos Aires, C1055AAF, Argentina

RECRUITING

Sanatorio del Sur S.A.

San Miguel de Tucumán, T4000IDK, Argentina

RECRUITING

Santa Casa de Misericordia de Salvador

Salvador, Estado de Bahia, 40050-410, Brazil

RECRUITING

Freire Pesquisa Clinica

Belo Horizonte, Minas Gerais, 30150, Brazil

WITHDRAWN

Instituto de Neurologia de Curitiba

Curitiba, Paraná, 81210-310, Brazil

RECRUITING

Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda

Porto Alegre, Rio Grande do Sul, 90110-000, Brazil

RECRUITING

Núcleo de Pesquisa do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

WITHDRAWN

Instituto do Cerebro do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

RECRUITING

Clinica Neurológica e Neurocirúrgica de Joinville

Joinville, Santa Catarina, 89202-165, Brazil

RECRUITING

Centro de Pesquisas Clinicas - CPCLIN

São Paulo, São Paulo, 01244-030, Brazil

RECRUITING

Hôpital Guillaume et René Laënnec

Nantes, 44805, France

RECRUITING

CHU de Nimes - Hopital Universitaire Caremeau

Nîmes, 30900, France

RECRUITING

Hopital Hautepierre - CHU Strasbourg

Strasbourg, 67098, France

RECRUITING

Charite - Universitätsmedizin Berlin

Berlin, 12203, Germany

RECRUITING

St. Josef-Hospital, Klinik für Neurologie

Bochum, 44791, Germany

RECRUITING

Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

Dresden, 01307, Germany

RECRUITING

Universitätsklinikum Tübingen, Zentrum für Neurologie

Tübingen, 72076, Germany

RECRUITING

Universitätsklinikum Ulm

Ulm, 89081, Germany

RECRUITING

AO.U. Policlinico Riuniti Foggia

Foggia, Apulia, 71100, Italy

RECRUITING

AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2

Naples, Campania, 80131, Italy

RECRUITING

Università degli studi della Campania Luigi Vanvitelli

Naples, Campania, 80138, Italy

RECRUITING

Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

Rome, Lazio, 00133, Italy

RECRUITING

NCL Institute Neuroscience

Rome, Lazio, 00178, Italy

RECRUITING

Fond. Istituto Neurologico C.Besta

Milan, Lombardy, 20133, Italy

RECRUITING

IRCCS Istituto Neurologico Neuromed

Pozzilli, Molise, 86077, Italy

RECRUITING

Clinstile S.A de C.V.

Mexico City, Mexico CITY (federal District), 06700, Mexico

RECRUITING

Inovacion y Desarrollo en ciencias de la salud

Mexico City, Mexico CITY (federal District), 14090, Mexico

RECRUITING

Neurociencias Prisma, A.C

San Luis Potosí City, San Luis Potosí, 78216, Mexico

RECRUITING

Neurociencias Estudios Clinicos S.C.

Culiacán, Sinaloa, 80020, Mexico

RECRUITING

ProNeuro Centrum Medyczne

?ory, 44-240, Poland

RECRUITING

Neurocentrum Bydgoszcz sp z o.o

Bydgoszcz, 85-796, Poland

RECRUITING

Centrum Neurologii Krzysztof Selmaj

Lodz, 90-324, Poland

RECRUITING

Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

Oświęcim, 32-600, Poland

RECRUITING

Nmedis sp. z o.o.

Rzeszów, 35-323, Poland

RECRUITING

IBISMED Wielospecjalistyczne Centrum Medyczne

Zabrze, 41-800, Poland

RECRUITING

Hospital de Gran Canaria Dr. Negrín

Las Palmas de Gran Canaria, LAS Palmas, 35010, Spain

RECRUITING

Hospital Universitario Virgen de Arrixaca

EL Palmar (EL Palmar), Murcia, 30120, Spain

RECRUITING

Hospital General Universitario de Albacete

Albacete, DUMMY_VALUE, Spain

RECRUITING

Hospital General Universitario de Alicante

Alicante, 03010, Spain

RECRUITING

Hospital Universitari Vall dHebron (CEMCAT)

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario de la Princesa

Madrid, 28006, Spain

RECRUITING

Hospital Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41007, Spain

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: CN45320 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S.); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 20, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): October 30, 2030
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

ES (8); PL (6); DE (5); US (9); BR (8); AR (6); ME (4); FR (3); IT (7)