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Clinical Trials in the USA / NCT07074886
Active, not recruiting Phase 2

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

NCT07074886 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2025-11-13
Last updated
2026-08-06

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

Ocrelizumab Test FormulationOcrelizumab Reference Formulation

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (50)

FacilityCityRegionStatus
Profound Research, LLC Carlsbad California
Advanced Neurology of Colorado, LLC Fort Collins Colorado
Neurology Associates PA Maitland Florida
University of South Florida Tampa Florida
Johns Hopkins University School Of Medicine Baltimore Maryland
University of Massachusetts Medical School Worcester Massachusetts
SUNY Upstate Medical University Syracuse New York
Hope Neurology Knoxville Tennessee
Swedish Medical Center Seattle Washington
Centro de Especialidades Neurológicas y Rehabilitación - CENyR CABA Buenos Aires
Focus CECIC CABA CABA / Buenos Aires
INECO Neurociencias Orono Rosario Santa Fe Province
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
Instituto de Neurologia de Curitiba Curitiba Paraná
Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda Porto Alegre Rio Grande do Sul
Instituto do Cerebro do Rio Grande do Sul Porto Alegre Rio Grande do Sul
Clinica Neurológica e Neurocirúrgica de Joinville Joinville Santa Catarina
Centro de Pesquisas Clinicas - CPCLIN São Paulo São Paulo
Hôpital Guillaume et René Laënnec Nantes France
CHU de Nimes - Hopital Universitaire Caremeau Nîmes 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
AO.U. Policlinico Riuniti Foggia Foggia Apulia
AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2 Naples Campania
Università degli studi della Campania Luigi Vanvitelli Naples Campania
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla Rome Lazio
NCL Institute Neuroscience Rome Lazio
Fond. Istituto Neurologico C.Besta Milan Lombardy
IRCCS Istituto Neurologico Neuromed Pozzilli Molise
Inovacion y Desarrollo en ciencias de la salud Mexico City Mexico CITY (federal District)
Neurociencias Prisma, A.C San Luis Potosí City San Luis Potosí
Neurociencias Estudios Clinicos S.C. Culiacán Sinaloa
ProNeuro Centrum Medyczne ?ory Poland
Neurocentrum Bydgoszcz sp z o.o Bydgoszcz Poland
Centrum Neurologii Krzysztof Selmaj Lodz Poland

+ 10 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07074886 on ClinicalTrials.gov ↗ ← All trials in the USA