NCT04115488

Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®

Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Polpharma Biologics S.A. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 3 multicenter, double-blind, active-controlled, randomized, parallel-group study to assess the equivalence in efficacy and similarity in safety of biosimilar PB006 compared to Tysabri in patients with RRMS. All eligible patients will be randomly assigned to one of two treatment groups in a 1:1 ratio, to receive a total of twelve intravenous (IV) infusion of either PB006 or Tysabri at a dose of 300 mg at each intravenous (IV) infusion administered with every single one intravenous (IV) infusion administered every 4 weeks of either PB006 or Tysabri at a dose of 300 mg starting at visit 1 (week 0) through visit 12 (week 44), for a total of 12 infusions. The End-of-Study Visit (visit 13, week 48) will be performed 4 weeks after the last infusion

Conditions

• Relapsing-Remitting Multiple Sclerosis (RRMS)

Interventions

Type	Name	Description
BIOLOGICAL	Intravenous (IV) infusions	Intravenous (IV) infusions of a dose of 300mg, every 4 weeks with a total of 12 doses

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-08-23
• Completion: 2022-02-07
• First posted: 2019-10-04
• Last updated: 2023-07-03
• Results posted: 2023-07-03

Locations

48 sites across 7 countries: Belarus, Croatia, Georgia, Moldova, Poland, Serbia, Ukraine

Regulatory

• FDA-regulated drug study