Status:
TERMINATED
A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple Sclerosis
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate the efficacy of natalizumab 300 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) administrations up to 24 weeks in Japanese participants with re...
Eligibility Criteria
Inclusion
- Key
- 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 12 months 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.
- Key
Exclusion
- Evidence of current severe acute respiratory syndrome coronavirus 2 (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 \[°C\]), 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 enrolment or, in the opinion of the investigator, the participant not having stabilized from a previous relapse prior to enrolment (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.
- Note: Other protocol specified Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
April 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05265728
Start Date
April 26 2022
End Date
May 27 2024
Last Update
November 25 2025
Active Locations (12)
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1
Juntendo University Hospital
Bunkyō City, Japan, 113-8431
2
Chiba University Hospital
Chiba, Japan, 260-8677
3
St.Marianna University Hospital
Kawasaki-shi, Japan, 216-8511
4
National Center of Neurology and Psychiatry
Kodaira-shi, Japan, 187-8551