Actively Recruiting
A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
Led by Hoffmann-La Roche · Updated on 2026-04-27
182
Participants Needed
56
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsing multiple sclerosis or primary progressive multiple sclerosis according to McDonald criteria
- Expanded Disability Status Scale (EDSS) score between 0 and 6.5 inclusive at screening
- Age between 18 and 65 years
You will not qualify if you...
- Previous anti-CD20 treatment, including ocrelizumab, within 2 years before screening
- Previous anti-CD20 treatment more than 2 years before screening if B-cell count is below normal or treatment stopped for safety reasons
- History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- History of cancer, including blood cancers and solid tumors, within 10 years before screening
- Being immunocompromised
- Sensitivity or intolerance to ocrelizumab or its ingredients
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- Any disease requiring chronic systemic corticosteroids or immunosuppressant treatment during the study
- Significant uncontrolled diseases such as cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, or other serious illnesses
- Lack of peripheral venous access
- Previous treatment with cladribine, atacicept, or alemtuzumab
- Previous bone marrow or hematopoietic stem cell transplantation
- Previous history of transplantation or anti-rejection therapy
- Positive screening tests for active, latent, or inadequately treated hepatitis B virus (HBV) infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 56 locations
1
Profound Research, LLC
Carlsbad, California, United States, 92011
Actively Recruiting
2
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, United States, 80528
Actively Recruiting
3
Neurology Associates PA
Maitland, Florida, United States, 32751
Actively Recruiting
4
University of South Florida
Tampa, Florida, United States, 33612
Actively Recruiting
5
Johns Hopkins University School Of Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
6
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01605
Actively Recruiting
7
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
8
Hope Neurology
Knoxville, Tennessee, United States, 37922
Actively Recruiting
9
Swedish Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
10
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
CABA, Buenos Aires, Argentina, C1424BYD
Actively Recruiting
11
Focus CECIC
CABA, CABA / Buenos Aires, Argentina, C1425BKU
Actively Recruiting
12
INECO Neurociencias Orono
Rosario, Santa Fe Province, Argentina, S2000DTC
Actively Recruiting
13
IME - Instituto Médico Especializado
Buenos Aires, Argentina, C1405BCH
Actively Recruiting
14
Centro de Investigacion en Enfermedades Reumaticas CIER
Ciudad Autonoma Buenos Aires, Argentina, C1055AAF
Actively Recruiting
15
Sanatorio del Sur S.A.
San Miguel de Tucumán, Argentina, T4000IDK
Actively Recruiting
16
Santa Casa de Misericordia de Salvador
Salvador, Estado de Bahia, Brazil, 40050-410
Actively Recruiting
17
Freire Pesquisa Clinica
Belo Horizonte, Minas Gerais, Brazil, 30150
Withdrawn
18
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil, 81210-310
Actively Recruiting
19
Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda
Porto Alegre, Rio Grande do Sul, Brazil, 90110-000
Actively Recruiting
20
Núcleo de Pesquisa do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
Withdrawn
21
Instituto do Cerebro do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Actively Recruiting
22
Clinica Neurológica e Neurocirúrgica de Joinville
Joinville, Santa Catarina, Brazil, 89202-165
Actively Recruiting
23
Centro de Pesquisas Clinicas - CPCLIN
São Paulo, São Paulo, Brazil, 01244-030
Actively Recruiting
24
Hôpital Guillaume et René Laënnec
Nantes, France, 44805
Actively Recruiting
25
CHU de Nimes - Hopital Universitaire Caremeau
Nîmes, France, 30900
Actively Recruiting
26
Hopital Hautepierre - CHU Strasbourg
Strasbourg, France, 67098
Actively Recruiting
27
Charite - Universitätsmedizin Berlin
Berlin, Germany, 12203
Actively Recruiting
28
St. Josef-Hospital, Klinik für Neurologie
Bochum, Germany, 44791
Actively Recruiting
29
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
Dresden, Germany, 01307
Actively Recruiting
30
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, Germany, 72076
Actively Recruiting
31
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
32
AO.U. Policlinico Riuniti Foggia
Foggia, Apulia, Italy, 71100
Actively Recruiting
33
AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2
Naples, Campania, Italy, 80131
Actively Recruiting
34
Università degli studi della Campania Luigi Vanvitelli
Naples, Campania, Italy, 80138
Actively Recruiting
35
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Rome, Lazio, Italy, 00133
Actively Recruiting
36
NCL Institute Neuroscience
Rome, Lazio, Italy, 00178
Actively Recruiting
37
Fond. Istituto Neurologico C.Besta
Milan, Lombardy, Italy, 20133
Actively Recruiting
38
IRCCS Istituto Neurologico Neuromed
Pozzilli, Molise, Italy, 86077
Actively Recruiting
39
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District), Mexico, 06700
Actively Recruiting
40
Inovacion y Desarrollo en ciencias de la salud
Mexico City, Mexico CITY (federal District), Mexico, 14090
Actively Recruiting
41
Neurociencias Prisma, A.C
San Luis Potosí City, San Luis Potosí, Mexico, 78216
Actively Recruiting
42
Neurociencias Estudios Clinicos S.C.
Culiacán, Sinaloa, Mexico, 80020
Actively Recruiting
43
ProNeuro Centrum Medyczne
?ory, Poland, 44-240
Actively Recruiting
44
Neurocentrum Bydgoszcz sp z o.o
Bydgoszcz, Poland, 85-796
Actively Recruiting
45
Centrum Neurologii Krzysztof Selmaj
Lodz, Poland, 90-324
Actively Recruiting
46
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
Oświęcim, Poland, 32-600
Actively Recruiting
47
Nmedis sp. z o.o.
Rzeszów, Poland, 35-323
Actively Recruiting
48
IBISMED Wielospecjalistyczne Centrum Medyczne
Zabrze, Poland, 41-800
Actively Recruiting
49
Hospital de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, LAS Palmas, Spain, 35010
Actively Recruiting
50
Hospital Universitario Virgen de Arrixaca
EL Palmar (EL Palmar), Murcia, Spain, 30120
Actively Recruiting
51
Hospital General Universitario de Albacete
Albacete, Spain, DUMMY_VALUE
Actively Recruiting
52
Hospital General Universitario de Alicante
Alicante, Spain, 03010
Actively Recruiting
53
Hospital Universitari Vall dHebron (CEMCAT)
Barcelona, Spain, 08035
Actively Recruiting
54
Hospital Universitario de la Princesa
Madrid, Spain, 28006
Actively Recruiting
55
Hospital Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
56
Hospital Universitario Virgen Macarena
Seville, Spain, 41007
Actively Recruiting
Research Team
R
Reference Study ID Number: CN45320 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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