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

NCT07074886 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: CN453202024-517980-22-00
• Study Type: interventional
• Target: 193
• Locations: 9 countries
• Sites: 50

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 (50)

Profound Research, LLC

Carlsbad, California, 92011, United States

Location

Advanced Neurology of Colorado, LLC

Fort Collins, Colorado, 80528, United States

Location

Neurology Associates PA

Maitland, Florida, 32751, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Johns Hopkins University School Of Medicine

Baltimore, Maryland, 21287, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01605, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Hope Neurology

Knoxville, Tennessee, 37922, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

Centro de Especialidades Neurológicas y Rehabilitación - CENyR

CABA, Buenos Aires, C1424BYD, Argentina

Location

Focus CECIC

CABA, CABA / Buenos Aires, C1425BKU, Argentina

Location

INECO Neurociencias Orono

Rosario, Santa Fe Province, S2000DTC, Argentina

Location

IME - Instituto Médico Especializado

Buenos Aires, C1405BCH, Argentina

Location

Centro de Investigacion en Enfermedades Reumaticas CIER

Ciudad Autonoma Buenos Aires, C1055AAF, Argentina

Location

Sanatorio del Sur S.A.

San Miguel de Tucumán, T4000IDK, Argentina

Location

Santa Casa de Misericordia de Salvador

Salvador, Estado de Bahia, 40050-410, Brazil

Location

Instituto de Neurologia de Curitiba

Curitiba, Paraná, 81210-310, Brazil

Location

Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda

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

Location

Instituto do Cerebro do Rio Grande do Sul

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

Location

Clinica Neurológica e Neurocirúrgica de Joinville

Joinville, Santa Catarina, 89202-165, Brazil

Location

Centro de Pesquisas Clinicas - CPCLIN

São Paulo, São Paulo, 01244-030, Brazil

Location

Hôpital Guillaume et René Laënnec

Nantes, 44805, France

Location

CHU de Nimes - Hopital Universitaire Caremeau

Nîmes, 30900, France

Location

Charite - Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

St. Josef-Hospital, Klinik für Neurologie

Bochum, 44791, Germany

Location

Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

Dresden, 01307, Germany

Location

Universitätsklinikum Tübingen, Zentrum für Neurologie

Tübingen, 72076, Germany

Location

AO.U. Policlinico Riuniti Foggia

Foggia, Apulia, 71100, Italy

Location

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

Naples, Campania, 80131, Italy

Location

Università degli studi della Campania Luigi Vanvitelli

Naples, Campania, 80138, Italy

Location

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

Rome, Lazio, 00133, Italy

Location

NCL Institute Neuroscience

Rome, Lazio, 00178, Italy

Location

Fond. Istituto Neurologico C.Besta

Milan, Lombardy, 20133, Italy

Location

IRCCS Istituto Neurologico Neuromed

Pozzilli, Molise, 86077, Italy

Location

Inovacion y Desarrollo en ciencias de la salud

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

Location

Neurociencias Prisma, A.C

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

Location

Neurociencias Estudios Clinicos S.C.

Culiacán, Sinaloa, 80020, Mexico

Location

ProNeuro Centrum Medyczne

?ory, 44-240, Poland

Location

Neurocentrum Bydgoszcz sp z o.o

Bydgoszcz, 85-796, Poland

Location

Centrum Neurologii Krzysztof Selmaj

Lodz, 90-324, Poland

Location

Nmedis sp. z o.o.

Rzeszów, 35-323, Poland

Location

IBISMED Wielospecjalistyczne Centrum Medyczne

Zabrze, 41-800, Poland

Location

Hospital de Gran Canaria Dr. Negrín

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

Location

Hospital Universitario Virgen de Arrixaca

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

Location

Hospital General Universitario de Albacete

Albacete, DUMMY_VALUE, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Universitari Vall dHebron (CEMCAT)

Barcelona, 08035, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41007, Spain

Location

Related Links

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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

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: September 17, 2026
• Study Completion (Estimated): March 31, 2030
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

ES (8); BR (6); IT (7); AR (6); ME (3); DE (4); PL (5); US (9); FR (2)