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

JRCT ID: jRCT2051210146

Registered date:26/12/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Relapsing-Remitting Multiple Sclerosis
• Date of first enrollment: 24/05/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Participants will receive natalizumab 300 mg SC Q4W for 48 weeks.

Outcome(s)

• Primary Outcome: Cumulative 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
• Gender: Both

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

• Primary Sponsor: Amir Hadi Maghzi
• Secondary ID(s): NCT05265728