NCT03320876

An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.

A Multicenter, Open-label, Long-term Extension Safety and Efficacy Study of Filgotinib Treatment in Subjects With Moderately to Severely Active Psoriatic Arthritis.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, multicenter, open-label, single arm, Long Term Extension (LTE) safety, tolerability and efficacy study of filgotinib in subjects with moderately to severely active PsA. It is estimated that approximately 105 subjects will be rolled-over after they have completed the 16 weeks of double-blind treatment in core study GLPG0634-CL-224. Subjects will be administered filgotinib in this study until filgotinib is registered for PsA or until Week 304, whichever occurs first. The LTE study is concluded with a follow-up visit approximately 4 weeks after the last intake of study treatment.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	filgotinib	one filgotinib oral tablet once daily.

Timeline

• Start date: 2017-07-26
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2017-10-25
• Last updated: 2022-04-21

Locations

25 sites across 7 countries: Belgium, Bulgaria, Czechia, Estonia, Poland, Spain, Ukraine