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A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
NCT07074886 · Hoffmann-La Roche
In plain English
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Official title
A Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis
About this study
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
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)
Study design
Enrollment target: 182 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-13
Estimated completion: 2030-10-30
Last updated: 2026-03-30
Interventions
Drug: Ocrelizumab Test FormulationDrug: Ocrelizumab Reference Formulation
Primary outcomes
- • 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)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: CN45320 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S.)
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (56)
Profound Research, LLCRecruiting
Carlsbad, California, United States
Advanced Neurology of Colorado, LLCRecruiting
Fort Collins, Colorado, United States
Neurology Associates PARecruiting
Maitland, Florida, United States
University of South FloridaRecruiting
Tampa, Florida, United States
Johns Hopkins University School Of MedicineRecruiting
Baltimore, Maryland, United States
University of Massachusetts Medical SchoolRecruiting
Worcester, Massachusetts, United States
SUNY Upstate Medical UniversityRecruiting
Syracuse, New York, United States
Hope NeurologyRecruiting
Knoxville, Tennessee, United States
Swedish Medical CenterRecruiting
Seattle, Washington, United States
Centro de Especialidades Neurológicas y Rehabilitación - CENyRRecruiting
CABA, Buenos Aires, Argentina
Focus CECICRecruiting
CABA, CABA / Buenos Aires, Argentina
INECO Neurociencias OronoRecruiting
Rosario, Santa Fe Province, Argentina
IME - Instituto Médico EspecializadoRecruiting
Buenos Aires, Argentina
Centro de Investigacion en Enfermedades Reumaticas CIERRecruiting
Ciudad Autonoma Buenos Aires, Argentina
Sanatorio del Sur S.A.Recruiting
San Miguel de Tucumán, Argentina
Santa Casa de Misericordia de SalvadorRecruiting
Salvador, Estado de Bahia, Brazil
Freire Pesquisa ClinicaRecruiting
Belo Horizonte, Minas Gerais, Brazil
Instituto de Neurologia de CuritibaRecruiting
Curitiba, Paraná, Brazil
Cpn - Centro de Pesquisa Neurologica Porto Alegre LtdaRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Núcleo de Pesquisa do Rio Grande do SulRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Instituto do Cerebro do Rio Grande do SulRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Clinica Neurológica e Neurocirúrgica de JoinvilleRecruiting
Joinville, Santa Catarina, Brazil
Centro de Pesquisas Clinicas - CPCLINRecruiting
São Paulo, São Paulo, Brazil
Hôpital Guillaume et René LaënnecRecruiting
Nantes, France
CHU de Nimes - Hopital Universitaire CaremeauRecruiting
Nîmes, France
Hopital Hautepierre - CHU StrasbourgRecruiting
Strasbourg, France
Charite - Universitätsmedizin BerlinRecruiting
Berlin, Germany
St. Josef-Hospital, Klinik für NeurologieRecruiting
Bochum, Germany
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische NeurowissenschaftenRecruiting
Dresden, Germany
Universitätsklinikum Tübingen, Zentrum für NeurologieRecruiting
Tübingen, Germany
Universitätsklinikum UlmRecruiting
Ulm, Germany
AO.U. Policlinico Riuniti FoggiaRecruiting
Foggia, Apulia, Italy
AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2Recruiting
Naples, Campania, Italy
Università degli studi della Campania Luigi VanvitelliRecruiting
Naples, Campania, Italy
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi MultiplaRecruiting
Rome, Lazio, Italy
NCL Institute NeuroscienceRecruiting
Rome, Lazio, Italy
Fond. Istituto Neurologico C.BestaRecruiting
Milan, Lombardy, Italy
IRCCS Istituto Neurologico NeuromedRecruiting
Pozzilli, Molise, Italy
Clinstile S.A de C.V.Recruiting
Mexico City, Mexico CITY (federal District), Mexico
Inovacion y Desarrollo en ciencias de la saludRecruiting
Mexico City, Mexico CITY (federal District), Mexico
Neurociencias Prisma, A.CRecruiting
San Luis Potosí City, San Luis Potosí, Mexico
Neurociencias Estudios Clinicos S.C.Recruiting
Culiacán, Sinaloa, Mexico
ProNeuro Centrum MedyczneRecruiting
?ory, Poland
Neurocentrum Bydgoszcz sp z o.oRecruiting
Bydgoszcz, Poland
Centrum Neurologii Krzysztof SelmajRecruiting
Lodz, Poland
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.Recruiting
Oświęcim, Poland
Nmedis sp. z o.o.Recruiting
Rzeszów, Poland
IBISMED Wielospecjalistyczne Centrum MedyczneRecruiting
Zabrze, Poland
Hospital de Gran Canaria Dr. NegrínRecruiting
Las Palmas de Gran Canaria, LAS Palmas, Spain
Hospital Universitario Virgen de ArrixacaRecruiting
EL Palmar (EL Palmar), Murcia, Spain
Hospital General Universitario de AlbaceteRecruiting
Albacete, Spain
Hospital General Universitario de AlicanteRecruiting
Alicante, Spain
Hospital Universitari Vall dHebron (CEMCAT)Recruiting
Barcelona, Spain
Hospital Universitario de la PrincesaRecruiting
Madrid, Spain
Hospital Ramon y CajalRecruiting
Madrid, Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain