Phase 3 Study to Evaluate Efficacy, Safety, PK, and PD of SC Natalizumab in Japanese Participants With RRMS
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Registration Number
- jRCT2051210146
- Lead Sponsor
- Biogen Japan Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 20
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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.
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Must have had an EDSS score between 0.0 and 5.5, inclusive.
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Must have had screening MRI or documentation of an MRI within the participant's medical record within 12months of the Screening Visit that revealed 3 or more T2 hyperintense lesions consistent with MS.
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Was born in Japan, and biological parents and grandparents were of Japanese origin.
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Evidence of current 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), new and persistent cough, breathlessness, or loss of taste and/or smell.
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Have close contact within 14 days prior to Day 1 with a SARS-CoV-2 positive individual.
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Diagnosis of primary progressive MS or secondary progressive MS.
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An MS exacerbation (relapse) within 30 days prior to enrollment or, in the opinion of the Investigator, the participant not having stabilized from a previous relapse prior to enrollment (Day 1).
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The participant is unable to have a brain MRI scan (e.g., a participant with a metal clip to repair a cerebral aneurysm).
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Previous exposure to natalizumab.
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method - Cumulative number of new active lesions on Week 24 brain MRI scans.
- Secondary Outcome Measures
Name Time Method Proportion of participants with any new active lesions Week 24 and Week 48 Proportion of participants with any new active lesions on Week 24 and Week 48 brain MRI scans.
The number of nonenhancing new or newly enlarging T2 hyperintense lesions Week 24 and Week 48 The number of nonenhancing new or newly enlarging T2 hyperintense lesions at Week 24 and Week 48.
The number of new T1 hypointense lesions Week 24 and Week 48 The number of new T1 hypointense lesions at Week 24 and Week 48.
Annualized Relapse Rate (ARR) Annualized Relapse Rate (ARR).
Proportion of relapse-free participants Week 24 and Week 52 Proportion of relapse-free participants at Week 24 and Week 52.
VAS assessing the participant's global impression of their well-being Week 24 and Week 48 VAS assessing the participant's global impression of their well-being at Week 24 and Week 48.
Incidence of treatment-emergent AEs and SAEs Incidence of treatment-emergent AEs and SAEs.
Cumulative number of new active lesions Week 48 Cumulative number of new active lesions on Week 48 brain MRI scans.
Change from baseline in number of gadolinium-enhancing lesions Week 24 and Week 48 Change from baseline in number of gadolinium-enhancing lesions at Week 24 and Week 48.
Anti-JCV antibody Anti-JCV antibody.
Anti-natalizumab antibodies Anti-natalizumab antibodies.
Change in EDSS score from Baseline Change in EDSS score from Baseline.
Serum natalizumab concentrations Serum natalizumab concentrations.
Alpha-4-integrin saturation and serum soluble VCAM-1 concentrations Alpha-4-integrin saturation and serum soluble VCAM-1 concentrations.