NCT03101670

A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 16 Weeks to Subjects With Moderately to Severely Active Psoriatic Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response or are intolerant to conventional disease-modifying therapy. A total of approximately 124 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo tablets q.d. The Screening visit will occur within 28 days before study drug administration. At Day 1 (Baseline), eligible subjects will be randomized to treatment for a duration of 16 weeks. The study is concluded with a Follow-up period lasting until 4 weeks after the last dose. Consequently, each subject will stay in the study for a maximum of 24 weeks (from Screening visit to Follow-up visit).

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	filgotinib	one filgotinib oral tablet q.d.
DRUG	Placebo Oral Tablet	one placebo oral tablet q.d.

Timeline

• Start date: 2017-03-09
• Primary completion: 2018-03-12
• Completion: 2018-03-12
• First posted: 2017-04-05
• Last updated: 2018-04-23

Locations

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