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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

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

Amir Hadi Maghzi

Biogen Japan Ltd.

Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027

japan-medinfo@biogen.com

Biogen Japan Medical Information

Biogen Japan Ltd.

Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027

+81-120-560-086

japan-medinfo@biogen.com

Not Recruiting

Feb. 24, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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.

Both

Relapsing-Remitting Multiple Sclerosis

Participants will receive natalizumab 300 mg SC Q4W for 48 weeks.

Cumulative number of new active lesions on Week 24 brain MRI scans.

- 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.

+81-6-6992-1001

Dec. 07, 2021

Yes

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

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