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

Amir Hadi Maghzi0 个研究点目标入组 20 人开始时间: 2021年12月26日最近更新: 2023年10月17日

试验速览

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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.
•- 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.

发起方

Amir Hadi Maghzi