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
Key facts
- Who runs it
- Biogen
- Where
- Japan12 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- Phase
- Phase 3
- People taking part
- 21 people enrolled
- Started
- 26 Apr 2022
- Ended
- 27 May 2024
- Type of study
- Interventional
- Treatments tested
- Natalizumab
- Record updated
- 25 November 2025
- Why it stopped
- Due to sponsor decision, not for efficacy or safety reasons.
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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
- 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)
- Previous exposure to natalizumab; Note: Other protocol specified Inclusion/Exclusion criteria may apply
- Diagnosis of primary progressive MS or secondary progressive MS
- The participant is unable to have a brain MRI scan (e.g., a participant with a metal clip to repair a cerebral aneurysm)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
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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.
The group in the trial
- NatalizumabTreatment being tested
Participants will receive natalizumab 300 mg SC Q4W for 48 weeks.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Single-Arm, Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered to Japanese Participants With Relapsing-Remitting Multiple Sclerosis Via a Subcutaneous Route of Administration
- Record updated
- 25 November 2025