A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration

Summary

Part 1: The primary objective is to evaluate the efficacy of natalizumab extended interval dosing (EID) (every 6 weeks \[Q6W\]) in participants who have previously been treated with natalizumab standard interval dosing (SID) (every 4 weeks \[Q4W\]) for at least 12 months, in relation to continued Q4W treatment. The secondary objectives is to evaluate relapse-based clinical efficacy measures, disability worsening, additional Magnetic resonance imaging (MRI)-lesion efficacy measures and safety of Q6W in participants who have previously been treated with natalizumab Q4W for at least 12 months, in relation to continued Q4W treatment. Part 2: The primary objective is to evaluate participant preference for subcutaneous (SC) versus intravenous (IV) route of natalizumab administration. The secondary objectives is to evaluate treatment satisfaction, drug preparation and administration time, safety and immunogenicity, efficacy and characterize pharmacokinetic (PK) and pharmacodynamic (PD) drug preparation and administration time of SC versus IV routes of natalizumab administration.

Timeline

Start

2018-11-27

Primary completion

2023-01-31

Completion

2023-07-24

Publications

• Foley JF, Defer G, Ryerson LZ, Cohen JA, Arnold DL, Butzkueven H, Cutter GR, Giovannoni G, Killestein J, Wiendl H, Li K, Dsilva L, Toukam M, Ferber K, Sohn J, Engelman H, Lasky T. Pharmacokinetics and Pharmacodynamics of Natalizumab 6-Week Dosing vs Continued 4-Week Dosing for Relapsing-Remitting Multiple Sclerosis. Neurol Neuroimmunol Neuroinflamm. 2024 Dec;11(6):e200321. doi: 10.1212/NXI.0000000000200321. Epub 2024 Oct 11.
• Wiendl H, Foley J, Defer G, Zhovtis Ryerson L, Cohen JA, Arnold DL, Butzkueven H, Cutter GR, Giovannoni G, Killestein J, Domingo-Horne R, Toukam M, Nunn A, Maghzi AH, Kuhelj R, Lasky T. Patient Preference for Subcutaneous Versus Intravenous Administration with Every-6-Week Natalizumab (Tysabri(R)) Dosing: NOVA Phase IIIb Extension Study (Part 2). Neurol Ther. 2024 Oct;13(5):1385-1401. doi: 10.1007/s40120-024-00647-0. Epub 2024 Jul 24.
• Foley JF, Defer G, Ryerson LZ, Cohen JA, Arnold DL, Butzkueven H, Cutter G, Giovannoni G, Killestein J, Wiendl H, Smirnakis K, Xiao S, Kong G, Kuhelj R, Campbell N; NOVA study investigators. Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis (NOVA): a randomised, controlled, open-label, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):608-619. doi: 10.1016/S1474-4422(22)00143-0. Epub 2022 Apr 25.

Drugs

Indications