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
- JPRN-jRCT2051210146
- Lead Sponsor
- Amir Hadi Maghzi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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 12months 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.
- 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.
- 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 enrollment or, in the opinion of the Investigator, the participant not having stabilized from a previous relapse prior to enrollment (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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method