NCT02294227

16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis

A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab (150 mg) in Pre-filled Syringe, With or Without Loading Regimen, to Demonstrate Efficacy, Safety and Tolerability up to 2 Years in Patients With Active Psoriatic Arthritis (FUTURE 4)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 341 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD therapy

Conditions

• Arthritis, Psoriatic

Interventions

Type	Name	Description
BIOLOGICAL	Secukinumab	Secukinumab 150 mg (1 mL liquid formulation) in pre-filled syringes were supplied by Novartis. Each secukinumab 300 mg dose was given as two sc injections of secukinumab 150 mg.
OTHER	Placebo	Placebo to secukinumab was also available in 1.0 mL liquid formulation in prefilled syringe to match the active drug.

Timeline

• Start date: 2015-05-29
• Primary completion: 2016-02-16
• Completion: 2017-12-19
• First posted: 2014-11-19
• Last updated: 2019-07-02
• Results posted: 2019-07-02

Locations

64 sites across 13 countries: United States, Australia, Belgium, Bulgaria, Canada, Czechia, France, Germany, Italy, Poland, Russia, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study