NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2051210146

Registered date:26/12/2021

Phase 3 Study to Evaluate Efficacy, Safety, PK, and PD of SC Natalizumab in Japanese Participants With RRMS

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedRelapsing-Remitting Multiple Sclerosis
Date of first enrollment24/05/2022
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Participants will receive natalizumab 300 mg SC Q4W for 48 weeks.

Outcome(s)

Primary OutcomeCumulative number of new active lesions on Week 24 brain MRI scans.
Secondary Outcome- Cumulative number of new active lesions on Week 48 brain MRI scans. - Proportion of participants with any new active lesions on Week 24 and Week 48 brain MRI scans. - Change from baseline in number of gadolinium-enhancing lesions at 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 at Week 24 and Week 48. - Annualized Relapse Rate (ARR). - Proportion of relapse-free participants at Week 24 and Week 52. - VAS assessing the participant's global impression of their well-being at Week 24 and Week 48. - Incidence of treatment-emergent AEs and SAEs. - Anti-JCV antibody. - Anti-natalizumab antibodies. - Change in EDSS score from Baseline. - Serum natalizumab concentrations. - Alpha-4-integrin saturation and serum soluble VCAM-1 concentrations.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 65age old
GenderBoth
Include criteria- 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.
Exclude criteria- 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.

Related Information

Contact

Public contact
Name Biogen Japan Medical Information
Address Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027 Tokyo Japan 103-0027
Telephone +81-120-560-086
E-mail japan-medinfo@biogen.com
Affiliation Biogen Japan Ltd.
Scientific contact
Name Maghzi Hadi Amir
Address Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027 Tokyo Japan 103-0027
Telephone +81-120-560-086
E-mail japan-medinfo@biogen.com
Affiliation Biogen Japan Ltd.