Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis

Summary

The purpose of this study was to provide up to 52 weeks of efficacy, safety and tolerability data to support registration of intravenous (i.v.) secukinumab (Initial dose of 6 mg/kg at Baseline (BSL) followed thereafter with 3 mg/kg administered every four weeks) in patients with active psoriatic arthritis (PsA) despite current or previous Non-steroidal anti-inflammatory drugs (NSAIDs), Disease-modifying antirheumatic drugs (DMARDs) and/or anti-tumor necrosis factor (TNF) therapy.

Timeline

Start

2020-01-29

Primary completion

2022-05-17

Completion

2022-05-17

Outcome

Met primary endpoint

registry analysis (superiority test); AIN457 6 mg/kg - 3 mg/kg i.v. vs Placebo to AIN457 3 mg/kg i.v.; p <.0001; Marginal difference 25.02 (95% CI 17.61 to 32.43) NCT04209205 ↗

Drugs

Indications