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

NCT ID: NCT05265728

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-26
• Study Completion Date: 2024-05-27

Brief 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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Natalizumab

Participants will receive natalizumab 300 mg SC Q4W for 48 weeks.

Group Type: EXPERIMENTAL

Natalizumab

Intervention Type: DRUG

Administered as specified in the treatment arm

Interventions

Natalizumab

Administered as specified in the treatment arm

Intervention Type: DRUG

Other Intervention Names

BG00002; Tysabri

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Juntendo University Hospital

Bunkyō City, , Japan

Chiba University Hospital

Chiba, , Japan

St.Marianna University Hospital

Kawasaki-shi, , Japan

National Center of Neurology and Psychiatry

Kodaira-shi, , Japan

Kansai Medical University Medical Center

Moriguchi-shi, , Japan

Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Ebara Hospital

Ōta-ku, , Japan

The Kitasato Institute Kitasato University Hospital

Sagamihara-shi, , Japan

National Hospital Organization Hokkaido Medical Center

Sapporo, , Japan

Tohoku Medical and Pharmaceutical University Hospital

Sendai, , Japan

Osaka University Hospital

Suita-shi, , Japan

University of Tsukuba Hospital

Tsukuba, , Japan

Tokyo Women's Medical University Yachiyo Medical Center

Yachiyo-shi, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

101MS330

Identifier Type: -

Identifier Source: org_study_id