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

NCT05265728 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 101MS330
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 12

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

Outcome Measures

Primary Outcomes (1)

• Part 1: Cumulative Number of New Active Lesions up to Week 24 Identified Using Brain Magnetic Resonance Imaging (MRI) Scans

  New active lesions were defined as the sum of gadolinium (Gd)-enhancing lesions and non-enhancing new or newly enlarging T2 hyperintense lesions over a period of 24 weeks.

  Up to Week 24

Secondary Outcomes (20)

• Part 2: Cumulative Number of New Active Lesions up to Week 48 Identified Using Brain MRI Scans

  Up to Week 48

• Part 1: Proportion of Participants With Any New Active Lesions at Week 24 Identified Using Brain MRI Scans

  At Week 24

• Part 2: Proportion of Participants With Any New Active Lesions at Week 48 Identified Using Brain MRI Scans

  At Week 48

• Change From Baseline in Number of Gd-Enhancing Lesions at Week 24 and Week 48

  Baseline, Weeks 24 and 48

• Number of Non-enhancing New or Newly Enlarging T2 Hyperintense Lesions at Week 24

  At Week 24

Study Arms (1)

Natalizumab

EXPERIMENTAL

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

Drug: Natalizumab

Interventions

Natalizumab DRUG

Administered as specified in the treatment arm

Also known as: BG00002, Tysabri

Natalizumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (12)

Juntendo University Hospital

Bunkyō City, 113-8431, Japan

Location

Chiba University Hospital

Chiba, 260-8677, Japan

Location

St.Marianna University Hospital

Kawasaki-shi, 216-8511, Japan

Location

National Center of Neurology and Psychiatry

Kodaira-shi, 187-8551, Japan

Location

Kansai Medical University Medical Center

Moriguchi-shi, 570-8507, Japan

Location

Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Ebara Hospital

Ōta-ku, 145-0065, Japan

Location

The Kitasato Institute Kitasato University Hospital

Sagamihara-shi, 252-0375, Japan

Location

National Hospital Organization Hokkaido Medical Center

Sapporo, 063-0005, Japan

Location

Tohoku Medical and Pharmaceutical University Hospital

Sendai, 983-8512, Japan

Location

Osaka University Hospital

Suita-shi, 565-0871, Japan

Location

University of Tsukuba Hospital

Tsukuba, 305-8576, Japan

Location

Tokyo Women's Medical University Yachiyo Medical Center

Yachiyo-shi, 276-8524, Japan

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 3, 2022
• Study Start: April 26, 2022
• Primary Completion: January 18, 2024
• Study Completion: May 27, 2024
• Last Updated: November 25, 2025
• Results First Posted: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

JP (12)