At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 265 enrolled
Drug / intervention
Intravenous (IV) infusionsbiological
Likely dose
Intravenous (IV) infusions 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)
In Brief
A Phase 3 clinical trial evaluating Intravenous (IV) infusions for Relapsing-Remitting Multiple Sclerosis (RRMS). Completed, enrolled 265 participants across 48 sites in 7 countries.
Detailed Summary
This is a multi-center, randomized, parallel arm, double-blind study with a total duration of subjects' participation of 48 weeks. Approximately 260 participants with relapsing-remitting multiple sclerosis will be randomized to receive 12 doses of either PB006 or EU-licensed Natalizumab.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelarus, Croatia, Georgia, Moldova, Poland, Serbia, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartOct 2019
First PostedOct 2019
Primary CompletionAug 2021
Study CompletionFeb 2022
TodayJul 2026
First PostedOct 4, 2019
Enrollment StartOct 1, 2019
Primary CompletionAug 23, 2021
Study CompletionFeb 7, 2022
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.7 years ago
Interventions
Intravenous (IV) infusionsbiological
Intravenous (IV) infusions of a dose of 300mg, every 4 weeks with a total of 12 doses