A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple Sclerosis

Last updated: November 13, 2025
Sponsor: Biogen
Overall Status: Terminated

Phase

3

Condition

Multiple Sclerosis

Scar Tissue

Memory Loss

Treatment

Natalizumab

Clinical Study ID

NCT05265728
101MS330
  • Ages 18-65
  • All Genders

Study Summary

The primary objective of this study is to evaluate the efficacy of natalizumab 300 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) administrations up to 24 weeks in Japanese participants with relapsing-remitting multiple sclerosis (RRMS).

The secondary objectives of the study are to evaluate other clinical and magnetic resonance imaging (MRI) measures of efficacy of natalizumab 300 mg SC Q4W administrations in Japanese participants with RRMS, to evaluate the safety, tolerability, and immunogenicity of natalizumab 300 mg SC Q4W administrations up to 48 weeks in Japanese participants with RRMS, to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of natalizumab 300 mg SC Q4W administrations up to 24 weeks and for an additional 24 weeks in Japanese participants with RRMS.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Must have had a diagnosis of RRMS, as defined by the revised 2017 McDonald'scriteria. All other possible neurologic diagnoses must have been reasonably excludedby 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'smedical record within 12 months of the screening visit that revealed 3 or more T2hyperintense lesions consistent with MS.

  • Was born in Japan, and biological parents and grandparents were of Japanese origin.

Exclusion

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 > 37.5degrees Celsius [°C]), new and persistent cough, breathlessness, or loss of tasteand/or smell.

  • Have close contact within 14 days prior to Day 1 with a SARS-CoV-2 positiveindividual.

  • Diagnosis of primary progressive MS or secondary progressive MS.

  • An MS exacerbation (relapse) within 30 days prior to enrolment or, in the opinion ofthe investigator, the participant not having stabilized from a previous relapseprior to enrolment (Day 1).

  • The participant is unable to have a brain MRI scan (e.g., a participant with a metalclip to repair a cerebral aneurysm).

  • Previous exposure to natalizumab.

Note: Other protocol specified Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 21
Treatment Group(s): 1
Primary Treatment: Natalizumab
Phase: 3
Study Start date:
April 26, 2022
Estimated Completion Date:
May 27, 2024

Connect with a study center

  • Juntendo University Hospital

    Bunkyo-ku, 113-8431
    Japan

    Site Not Available

  • Juntendo University Hospital

    Bunkyō City 11790632, 113-8431
    Japan

    Site Not Available

  • Chiba University Hospital

    Chiba 2113015, 260-8677
    Japan

    Site Not Available

  • Chiba University Hospital

    Chiba-shi, 260-8677
    Japan

    Site Not Available

  • St.Marianna University Hospital

    Kawasaki-shi, 216-8511
    Japan

    Site Not Available

  • National Center of Neurology and Psychiatry

    Kodaira-shi, 187-8551
    Japan

    Site Not Available

  • Kansai Medical University Medical Center

    Moriguchi-shi, 570-8507
    Japan

    Site Not Available

  • Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Ebara Hospital

    Ota-ku, 145-0065
    Japan

    Site Not Available

  • The Kitasato Institute Kitasato University Hospital

    Sagamihara-shi, 252-0375
    Japan

    Site Not Available

  • National Hospital Organization Hokkaido Medical Center

    Sapporo 2128295, 063-0005
    Japan

    Site Not Available

  • National Hospital Organization Hokkaido Medical Center

    Sapporo-shi, 063-0005
    Japan

    Site Not Available

  • Tohoku Medical and Pharmaceutical University Hospital

    Sendai 2111149, 983-8512
    Japan

    Site Not Available

  • Tohoku Medical and Pharmaceutical University Hospital

    Sendai-shi, 983-8512
    Japan

    Site Not Available

  • Osaka University Hospital

    Suita-shi, 565-0871
    Japan

    Site Not Available

  • University of Tsukuba Hospital

    Tsukuba 2110681, 305-8576
    Japan

    Site Not Available

  • University of Tsukuba Hospital

    Tsukuba-shi, 305-8576
    Japan

    Site Not Available

  • Tokyo Women's Medical University Yachiyo Medical Center

    Yachiyo-shi, 276-8524
    Japan

    Site Not Available

  • Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Ebara Hospital

    Ōta-ku 8469289, 145-0065
    Japan

    Site Not Available

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