A Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis
Status: Recruiting
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Profound Research, LLC
RECRUITING
Carlsbad
Colorado
Advanced Neurology of Colorado, LLC
RECRUITING
Fort Collins
Florida
Neurology Associates PA
RECRUITING
Maitland
Tennessee
Hope Neurology
RECRUITING
Knoxville
Other Locations
Argentina
IME - Instituto Médico Especializado
RECRUITING
Buenos Aires
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
RECRUITING
Caba
Focus CECIC
RECRUITING
Caba
Centro de Investigacion en Enfermedades Reumaticas CIER
RECRUITING
Ciudad Autonoma Buenos Aires
INECO Neurociencias Orono
RECRUITING
Rosario
Sanatorio del Sur S.A.
RECRUITING
San Miguel De Tucumán
Brazil
Freire Pesquisa Clinica
RECRUITING
Belo Horizonte
Instituto de Neurologia de Curitiba
RECRUITING
Curitiba
Clinica Neurológica e Neurocirúrgica de Joinville
RECRUITING
Joinville
Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda
RECRUITING
Porto Alegre
Instituto do Cerebro do Rio Grande do Sul
RECRUITING
Porto Alegre
Núcleo de Pesquisa do Rio Grande do Sul
RECRUITING
Porto Alegre
Santa Casa de Misericordia de Salvador
RECRUITING
Salvador
Centro de Pesquisas Clinicas - CPCLIN
RECRUITING
São Paulo
Germany
Charite - Universitätsmedizin Berlin
RECRUITING
Berlin
Italy
AO.U. Policlinico Riuniti Foggia
RECRUITING
Foggia
IRCCS Istituto Neurologico Neuromed
RECRUITING
Pozzilli
NCL Institute Neuroscience
RECRUITING
Rome
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
RECRUITING
Rome
Mexico
Neurociencias Estudios Clinicos S.C.
RECRUITING
Culiacán
Clinstile S.A de C.V.
RECRUITING
Mexico City
Inovacion y Desarrollo en ciencias de la salud
RECRUITING
Mexico City
Neurociencias Prisma, A.C
RECRUITING
San Luis Potosí City
Poland
ProNeuro Centrum Medyczne
RECRUITING
?ory
Neurocentrum Bydgoszcz sp z o.o
RECRUITING
Bydgoszcz
Centrum Neurologii Krzysztof Selmaj
RECRUITING
Lodz
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
RECRUITING
Oświęcim
Nmedis sp. z o.o.
RECRUITING
Rzeszów
IBISMED Wielospecjalistyczne Centrum Medyczne
RECRUITING
Zabrze
Spain
Complejo Hospitalario Universitario de Albacete
RECRUITING
Albacete
Hospital General Universitario de Alicante
RECRUITING
Alicante
Hospital Universitari Vall dHebron (CEMCAT)
RECRUITING
Barcelona
Hospital Universitario Virgen de Arrixaca
RECRUITING
El Palmar (el Palmar)
Hospital de Gran Canaria Dr. Negrín
RECRUITING
Las Palmas De Gran Canaria
Hospital Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario de la Princesa
RECRUITING
Madrid
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Contact Information
Primary
Reference Study ID Number: CN45320 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S.)
Time Frame
Start Date: 2025-11-13
Estimated Completion Date: 2030-10-30
Participants
Target number of participants: 182
Treatments
Experimental: Ocrelizumab Test Formulation
Participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the controlled phase and continuation phase.
Active_comparator: Ocrelizumab Reference Formulation
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.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche