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New ocrelizumab formula under study for MS patients

NCT ID NCT07074886

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

193 people

The number who actually took part.

Started

Nov 2025

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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

  • AO.U. Policlinico Riuniti Foggia

    Foggia, Apulia, 71100, Italy

  • AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2

    Naples, Campania, 80131, Italy

  • Advanced Neurology of Colorado, LLC

    Fort Collins, Colorado, 80528, United States

  • CHU de Nimes - Hopital Universitaire Caremeau

    Nîmes, 30900, France

  • Centro de Especialidades Neurológicas y Rehabilitación - CENyR

    CABA, Buenos Aires, C1424BYD, Argentina

  • Centro de Investigacion en Enfermedades Reumaticas CIER

    Ciudad Autonoma Buenos Aires, C1055AAF, Argentina

  • Centro de Pesquisas Clinicas - CPCLIN

    São Paulo, São Paulo, 01244-030, Brazil

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 90-324, Poland

  • Charite - Universitätsmedizin Berlin

    Berlin, 12203, Germany

  • Clinica Neurológica e Neurocirúrgica de Joinville

    Joinville, Santa Catarina, 89202-165, Brazil

  • Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda

    Porto Alegre, Rio Grande do Sul, 90110-000, Brazil

  • Focus CECIC

    CABA, CABA / Buenos Aires, C1425BKU, Argentina

  • Fond. Istituto Neurologico C.Besta

    Milan, Lombardy, 20133, Italy

  • Hope Neurology

    Knoxville, Tennessee, 37922, United States

  • Hospital General Universitario de Albacete

    Albacete, DUMMY_VALUE, Spain

  • Hospital General Universitario de Alicante

    Alicante, 03010, Spain

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitari Vall dHebron (CEMCAT)

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41007, Spain

  • Hospital Universitario Virgen de Arrixaca

    EL Palmar (EL Palmar), Murcia, 30120, Spain

  • Hospital Universitario de la Princesa

    Madrid, 28006, Spain

  • Hospital de Gran Canaria Dr. Negrín

    Las Palmas de Gran Canaria, LAS Palmas, 35010, Spain

  • Hôpital Guillaume et René Laënnec

    Nantes, 44805, France

  • IBISMED Wielospecjalistyczne Centrum Medyczne

    Zabrze, 41-800, Poland

  • IME - Instituto Médico Especializado

    Buenos Aires, C1405BCH, Argentina

  • INECO Neurociencias Orono

    Rosario, Santa Fe Province, S2000DTC, Argentina

  • IRCCS Istituto Neurologico Neuromed

    Pozzilli, Molise, 86077, Italy

  • Inovacion y Desarrollo en ciencias de la salud

    Mexico City, Mexico CITY (federal District), 14090, Mexico

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310, Brazil

  • Instituto do Cerebro do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Johns Hopkins University School Of Medicine

    Baltimore, Maryland, 21287, United States

  • NCL Institute Neuroscience

    Rome, Lazio, 00178, Italy

  • Neurocentrum Bydgoszcz sp z o.o

    Bydgoszcz, 85-796, Poland

  • Neurociencias Estudios Clinicos S.C.

    Culiacán, Sinaloa, 80020, Mexico

  • Neurociencias Prisma, A.C

    San Luis Potosí City, San Luis Potosí, 78216, Mexico

  • Neurology Associates PA

    Maitland, Florida, 32751, United States

  • Nmedis sp. z o.o.

    Rzeszów, 35-323, Poland

  • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

    Rome, Lazio, 00133, Italy

  • ProNeuro Centrum Medyczne

    ?ory, 44-240, Poland

  • Profound Research, LLC

    Carlsbad, California, 92011, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Sanatorio del Sur S.A.

    San Miguel de Tucumán, T4000IDK, Argentina

  • Santa Casa de Misericordia de Salvador

    Salvador, Estado de Bahia, 40050-410, Brazil

  • St. Josef-Hospital, Klinik für Neurologie

    Bochum, 44791, Germany

  • Swedish Medical Center

    Seattle, Washington, 98104, United States

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01605, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

  • Università degli studi della Campania Luigi Vanvitelli

    Naples, Campania, 80138, Italy

  • Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

    Dresden, 01307, Germany

  • Universitätsklinikum Tübingen, Zentrum für Neurologie

    Tübingen, 72076, Germany

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