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Could MS patients switch to once-yearly infusions? new trial aims to find out

NCT ID NCT05999604

Disease control Sponsor: Fondation Ophtalmologique Adolphe de Rothschild 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 28, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether people with active multiple sclerosis who have been stable on Ocrevus for at least two years can safely switch to annual infusions instead of the standard every-6-month schedule. The goal is to see if the less frequent dosing is just as good at preventing new brain lesions, while potentially lowering infection risk and reducing hospital visits. About 244 adults will be randomly assigned to receive Ocrevus either once or twice a year for two years.

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)
What this could lead to
If successful, this could allow people with stable MS to receive infusions once a year instead of twice, reducing infection risk and treatment burden.
What could go wrong
This is a non-inferiority trial, so it may show that annual dosing is slightly less effective at preventing new brain lesions. The study is also relatively small (244 people) and only follows participants for two years.

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

About 244 people

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

Started

Nov 2023

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: 1. Patient 18 years of age or older 2. Presenting for a 4th semi-annual cycle of ocrelizumab (minimum) 3. Requires follow-up MRI as part of treatment. 4. Initial indication for ocrelizumab according to the marketing authorization (active MS, RR or SP form) 5. Absence of relapse for at least 18 months (a relapse being defined as the appearance of new symptoms or worsening of existing symptoms, lasting more than 24 hours and outside a period of fever or an infectious episode; notified as a validated relapse by the neurologist in the patient's file, treated or not with boluses of Solu-Medrol). 6. EDSS between 0 and 6 inclusive 7. Having received informed information about the study and having signed a consent to participate in the study 8. French language proficiency 9. Affiliated or beneficiary of a social insurance scheme Exclusion Criteria: 1. Clinical forms of primary progressive MS 2. Patients already receiving systematically spaced doses of ocrelizumab ≥ 9 months apart 3. Contraindication to continued treatment with ocrelizumab (hypersensitivity reaction, ongoing active infection, development of malignancy since previous injection, development of severe immune deficiency) 4. Planned pregnancy within 3 years 5. Contraindication to MRI 6. Contraindication to injection of contrast media 7. Subject with severe or uncontrolled symptoms of renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric or cardiac disease, or any uncontrolled intercurrent pathology. 8. Patient under legal protection 9. Patients of childbearing age who do not wish to use effective contraception 10. Pregnant or breast-feeding women

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Conditions

The condition(s) this trial relates to.

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

  • CH Gonesse

    Gonesse, 95500, France

  • CHI Poissy-Saint-Germain en Laye

    Poissy, 78300, France

  • CHU de Grenoble

    Grenoble, 38043, France

  • CHU de Limoges

    Limoges, 87042, France

  • CHU de Nice

    Nice, 06000, France

  • CHU de Strasbourg

    Strasbourg, 67098, France

  • Fondation Adolphe de Rothschild

    Paris, 75019, France

  • Hôpital Foch

    Suresnes, 92150, France

  • Hôpital Henri Mondor

    Créteil, 94010, France

  • Hôpital Pierre Wertheimer (HCL)

    Lyon, 69500, France

  • Hôpital de la Pitié-Salpêtrière

    Paris, 75013, France

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Other studies related to the condition(s) this trial covers.