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Could a simple injection replace an IV for MS treatment?

NCT ID NCT05232825

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This study is testing whether a subcutaneous (under the skin) injection of ocrelizumab works as well as the standard intravenous (IV) infusion for people with relapsing or primary progressive multiple sclerosis. The trial will compare how the drug is absorbed, its safety, and its effects on the disease, including brain lesions seen on MRI. Participants will receive either the injection or the infusion, along with pre-medications to reduce infusion reactions.

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 the injection works as well as the infusion, it could offer people with MS a more convenient way to receive this treatment, potentially improving quality of life.
What could go wrong
The injection might not deliver the drug as effectively as the infusion, or it could cause different side effects. The trial is still in progress, so results are not yet known.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

236 people

The number who actually took part.

Started

May 2022

Finished

Jun 2025

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 PPMS or RMS according to the revised McDonald 2017 criteria (Thompson et al. 2018) * EDSS score, 0-6.5, inclusive, at screening * Neurological stability for ≥30 days prior to both screening and baseline * Disease duration from onset of MS symptoms of less than 15 years for patients with EDSS score \<2.0 at screening * For females participants, without reproductive potential may be enrolled if post-menopausal, unless receiving a hormonal therapy for menopause or if surgically sterile * For females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods Exclusion Criteria: * Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV anti microbials within 8 weeks prior to and during screening or treatment with oral anti microbials within 2 weeks prior to and during screening * 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 * Receipt of a live-attenuated vaccine within 6 weeks prior to randomization Influenza vaccination is permitted if the inactivated vaccine formulation is administered * Inability to complete an MRI or contraindication to gadolinium administration * Contraindications to mandatory premedications for IRRs, including closed-angle glaucoma for antihistamines * Known presence of other neurologic disorders * 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 patient from participating in the study * History of or currently active primary or secondary (non-drug-related) immunodeficiency * Pregnant or breastfeeding, or intending to become pregnant during the study and 6 or 12 months * Lack of peripheral venous access * History of alcohol or other drug abuse within 12 months prior to screening * Treatment with any investigational agent within 24 weeks prior to screening or 5 half-lives of the investigational drug (whichever is longer), or treatment with any experimental procedure for MS (e.g., treatment for chronic cerebrospinal venous insufficiency) * Participants who have previously received anti-CD20s if the last treatment was less than 2 years before screening, and/or if B-cell count is below lower limit of normal, and/or the discontinuation of the treatment was due to safety reasons or lack of efficacy * Previous treatment with cladribine, atacicept, and alemtuzumab * Previous treatment with fingolimod, siponimod, ponesimod, or ozanimod within 6 weeks of baseline * Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline * Previous treatment with natalizumab within 4.5 months of baseline * Treatment with mitoxantrone within 2 years prior to baseline visit or evidence of cardiotoxicity following mitoxantrone use or a cumulative lifetime dose of more than 60 mg/m2 * Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label. * If the washout requirements are not described in the applicable local label, then the wash out period must be 5 times the half-life of the medication. The PD effects of the previous medication must also be considered when determining the required time for washout. * Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation * Any previous history of transplantation or anti-rejection therapy * Treatment with IV Ig or plasmapheresis within 12 weeks prior to randomization * Systemic corticosteroid therapy within 4 weeks prior to screening * Positive screening tests for active, latent, or inadequately treated hepatitis B * Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab * Any additional exclusionary criterion as per ocrelizumab (Ocrevus®) local label, if more stringent than the above

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Conditions

The condition(s) this trial relates to.

chronic progressive multiple sclerosis primary progressive multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary progressive multiple sclerosis Relapsing multiple sclerosis

Contacts and locations

Locations

  • Azienda Ospedaliera Sant'Andrea

    Rome, Lazio, 00189, Italy

  • Bakirkoy State Mental Hospital

    Istanbul, 34000, Turkey (Türkiye)

  • CEDOES - Diagnóstico e Pesquisa

    Vitória, Espírito Santo, 29055-450, Brazil

  • Care Clinic

    Katowice, 40-568, Poland

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 90-324, Poland

  • Charles University, Medical faculty, Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Clinica Amo Assistencia Medica Em Oncologia

    Salvador, Estado de Bahia, 41950640, Brazil

  • Complejo Hospitalario Nuestra Señora de la Candelaria

    Santa Cruz de Tenerife, Tenerife, 38010, Spain

  • Fakultni nemocnice Motol

    Prague, 150 06, Czechia

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 708 52, Czechia

  • Fakultni nemocnice u sv. Anny

    Brno, 656 91, Czechia

  • Fakultni poliklinika VFN

    Prague, 128 08, Czechia

  • Hawkes Bay Hospital

    Hastings, 4120, New Zealand

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14011, Spain

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla, 41071, Spain

  • IRCCS Istituto Neurologico Neuromed

    Pozzilli, Molise, 86077, Italy

  • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi

    Istanbul, 34098, Turkey (Türkiye)

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Katip Celebi University Ataturk Training and Research Hospital

    Izmir, 35360, Turkey (Türkiye)

  • Kocaeli University Hospital

    Kocaeli, 41380, Turkey (Türkiye)

  • Krajska zdravotni a.s Nemocnice Teplice o.z.

    Teplice, 415 01, Czechia

  • Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

    Owosso, Michigan, 48867, United States

  • Namik Kemal Universitesi Sagli Uygulama ve Arastirma Hastanesi

    Süleymanpa?a, 59100, Turkey (Türkiye)

  • Nemocnice Jihlava

    Jihlava, 58633, Czechia

  • Neurocentrum Bydgoszcz sp. z o.o

    Bydgoszcz, 85-796, Poland

  • Neurology Associates PA

    Maitland, Florida, 32751, United States

  • Neurology Clinic PC

    Cordova, Tennessee, 38018, United States

  • Optimal Clinical Trials

    Auckland, 1010, New Zealand

  • Ospedale Civile di Montichiari

    Montichiari, Lombardy, 25018, Italy

  • Pardubicka Krajska Nemocnice

    Pardubice, 532 03, Czechia

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

    Rome, Lazio, 00133, Italy

  • Premier Neurology

    Greenville, South Carolina, 29605, United States

  • Przychodnia EuroMediCare

    Wroc?aw, 50-220, Poland

  • UC Health Neurology

    Dayton, Ohio, 45417, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

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