New ocrelizumab formula under study for MS patients
NCT ID NCT07074886
First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 4 times
Summary
This study compares two versions of the drug ocrelizumab given as a shot under the skin in people with multiple sclerosis. The goal is to see if the new test version works the same as the current one. About 182 participants with relapsing or primary progressive MS will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ocrelizumab
- What this could lead to
- If successful, this could confirm that a new formulation of ocrelizumab works as well as the current one, potentially offering more options for MS treatment.
- What could go wrong
- This is an early phase 2 study focused on bioequivalence, not on proving the drug works better. It may not lead to any change in treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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193 people
The number who actually took part.
- Started
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Nov 2025
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AO.U. Policlinico Riuniti Foggia
Foggia, Apulia, 71100, Italy
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AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2
Naples, Campania, 80131, Italy
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Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, 80528, United States
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CHU de Nimes - Hopital Universitaire Caremeau
Nîmes, 30900, France
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Centro de Especialidades Neurológicas y Rehabilitación - CENyR
CABA, Buenos Aires, C1424BYD, Argentina
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Centro de Investigacion en Enfermedades Reumaticas CIER
Ciudad Autonoma Buenos Aires, C1055AAF, Argentina
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Centro de Pesquisas Clinicas - CPCLIN
São Paulo, São Paulo, 01244-030, Brazil
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Centrum Neurologii Krzysztof Selmaj
Lodz, 90-324, Poland
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Charite - Universitätsmedizin Berlin
Berlin, 12203, Germany
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Clinica Neurológica e Neurocirúrgica de Joinville
Joinville, Santa Catarina, 89202-165, Brazil
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Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda
Porto Alegre, Rio Grande do Sul, 90110-000, Brazil
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Focus CECIC
CABA, CABA / Buenos Aires, C1425BKU, Argentina
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Fond. Istituto Neurologico C.Besta
Milan, Lombardy, 20133, Italy
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Hope Neurology
Knoxville, Tennessee, 37922, United States
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Hospital General Universitario de Albacete
Albacete, DUMMY_VALUE, Spain
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Hospital General Universitario de Alicante
Alicante, 03010, Spain
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Hospital Ramon y Cajal
Madrid, 28034, Spain
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Hospital Universitari Vall dHebron (CEMCAT)
Barcelona, 08035, Spain
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Hospital Universitario Virgen Macarena
Seville, 41007, Spain
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Hospital Universitario Virgen de Arrixaca
EL Palmar (EL Palmar), Murcia, 30120, Spain
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Hospital Universitario de la Princesa
Madrid, 28006, Spain
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Hospital de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, LAS Palmas, 35010, Spain
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Hôpital Guillaume et René Laënnec
Nantes, 44805, France
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IBISMED Wielospecjalistyczne Centrum Medyczne
Zabrze, 41-800, Poland
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IME - Instituto Médico Especializado
Buenos Aires, C1405BCH, Argentina
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INECO Neurociencias Orono
Rosario, Santa Fe Province, S2000DTC, Argentina
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IRCCS Istituto Neurologico Neuromed
Pozzilli, Molise, 86077, Italy
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Inovacion y Desarrollo en ciencias de la salud
Mexico City, Mexico CITY (federal District), 14090, Mexico
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Instituto de Neurologia de Curitiba
Curitiba, Paraná, 81210-310, Brazil
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Instituto do Cerebro do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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Johns Hopkins University School Of Medicine
Baltimore, Maryland, 21287, United States
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NCL Institute Neuroscience
Rome, Lazio, 00178, Italy
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Neurocentrum Bydgoszcz sp z o.o
Bydgoszcz, 85-796, Poland
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Neurociencias Estudios Clinicos S.C.
Culiacán, Sinaloa, 80020, Mexico
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Neurociencias Prisma, A.C
San Luis Potosí City, San Luis Potosí, 78216, Mexico
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Neurology Associates PA
Maitland, Florida, 32751, United States
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Nmedis sp. z o.o.
Rzeszów, 35-323, Poland
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Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Rome, Lazio, 00133, Italy
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ProNeuro Centrum Medyczne
?ory, 44-240, Poland
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Profound Research, LLC
Carlsbad, California, 92011, United States
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SUNY Upstate Medical University
Syracuse, New York, 13210, United States
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Sanatorio del Sur S.A.
San Miguel de Tucumán, T4000IDK, Argentina
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Santa Casa de Misericordia de Salvador
Salvador, Estado de Bahia, 40050-410, Brazil
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St. Josef-Hospital, Klinik für Neurologie
Bochum, 44791, Germany
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Swedish Medical Center
Seattle, Washington, 98104, United States
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University of Massachusetts Medical School
Worcester, Massachusetts, 01605, United States
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University of South Florida
Tampa, Florida, 33612, United States
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Università degli studi della Campania Luigi Vanvitelli
Naples, Campania, 80138, Italy
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Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
Dresden, 01307, Germany
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Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, 72076, Germany
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Other studies related to the condition(s) this trial covers.
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