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New MS drug trial for japanese patients shows promise but study stopped early

NCT ID NCT05265728

Disease control Sponsor: Biogen 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested the drug natalizumab in 21 Japanese adults with relapsing-remitting multiple sclerosis (MS). The goal was to see if injections under the skin every 4 weeks could reduce new brain lesions over 24 weeks, and to check safety for up to 48 weeks. The study was terminated early, so results are limited. Natalizumab is an existing MS treatment that helps control disease but does not cure it.

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

21 people

The number who actually took part.

Started

Apr 2022

Finished

May 2024

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.

Key Inclusion Criteria: * Must have had a diagnosis of RRMS, as defined by the revised 2017 McDonald's criteria. All other possible neurologic diagnoses must have been reasonably excluded by means of laboratory and/or imaging studies, in the opinion of the investigator. * Must have had an EDSS score between 0.0 and 5.5, inclusive. * Must have had screening MRI or documentation of an MRI within the participant's medical record within 12 months of the screening visit that revealed 3 or more T2 hyperintense lesions consistent with MS. * Was born in Japan, and biological parents and grandparents were of Japanese origin. Key Exclusion Criteria: * Evidence of current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 14 days prior to Screening, between screening and baseline visit, or at baseline visit, including but not limited to a fever (temperature \> 37.5 degrees Celsius \[°C\]), new and persistent cough, breathlessness, or loss of taste and/or smell. * Have close contact within 14 days prior to Day 1 with a SARS-CoV-2 positive individual. * Diagnosis of primary progressive MS or secondary progressive MS. * An MS exacerbation (relapse) within 30 days prior to enrolment or, in the opinion of the investigator, the participant not having stabilized from a previous relapse prior to enrolment (Day 1). * The participant is unable to have a brain MRI scan (e.g., a participant with a metal clip to repair a cerebral aneurysm). * Previous exposure to natalizumab. Note: Other protocol specified Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

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, relapsing-remitting

Contacts and locations

Locations

  • Chiba University Hospital

    Chiba, 260-8677, Japan

  • Juntendo University Hospital

    Bunkyō City, 113-8431, Japan

  • Kansai Medical University Medical Center

    Moriguchi-shi, 570-8507, Japan

  • National Center of Neurology and Psychiatry

    Kodaira-shi, 187-8551, Japan

  • National Hospital Organization Hokkaido Medical Center

    Sapporo, 063-0005, Japan

  • Osaka University Hospital

    Suita-shi, 565-0871, Japan

  • St.Marianna University Hospital

    Kawasaki-shi, 216-8511, Japan

  • The Kitasato Institute Kitasato University Hospital

    Sagamihara-shi, 252-0375, Japan

  • Tohoku Medical and Pharmaceutical University Hospital

    Sendai, 983-8512, Japan

  • Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Ebara Hospital

    Ōta-ku, 145-0065, Japan

  • Tokyo Women's Medical University Yachiyo Medical Center

    Yachiyo-shi, 276-8524, Japan

  • University of Tsukuba Hospital

    Tsukuba, 305-8576, Japan

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