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MS drug ocrelizumab gets a Needle-Free makeover: new shot form tested

NCT ID NCT07667322

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This early-stage trial is testing a new way to give ocrelizumab (Ocrevus) for multiple sclerosis — as a simple shot under the skin instead of a long IV infusion. About 75 adults with MS will receive increasing doses to see if the new form is safe and tolerable. If it works, it could make treatment much more convenient.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ocrelizumab (Ocrevus) given as a shot under the skin
What this could lead to
If successful, this could offer a more convenient way to take ocrelizumab for multiple sclerosis, potentially reducing infusion time and side effects.
What could go wrong
This is an early Phase 1 trial with only 75 people, so safety and effectiveness are not yet proven. The new injection form may cause different side effects or not work as well as the current IV version.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Aug 2028

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 Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018) * Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening Exclusion Criteria: * Participants who have previously received anti-cluster of differentiation 20 (CD20s) (including ocrelizumab) less than 2 years before screening * Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials 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 * 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 (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), 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 * Previous treatment with fingolimod, siponimod, ponesimod, or ozanimod within 6 weeks of baseline * 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 * Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab

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Conditions

The condition(s) this trial relates to.

chronic progressive multiple sclerosis multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

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

Multiple sclerosis

Contacts and locations

Locations

  • Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

    Guadalajara, Jalisco, 44130, Mexico

  • Centro de Pesquisas Clinicas

    São Paulo, São Paulo, 01228-200, Brazil

  • Hope Neurology

    Knoxville, Tennessee, 37922, United States

  • 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

  • John Hopkins University School of Medicine

    Baltimore, Maryland, 21287, United States

  • Morriston Hospital

    Swansea, SA6 6NL, United Kingdom

  • Neurology Associates, PA

    Maitland, Florida, 32751, United States

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH, United Kingdom

  • Profound Research, LLC

    Carlsbad, California, 92011, United States

  • Shepherd Center Inc.

    Atlanta, Georgia, 30309, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

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