NCT04115839

Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the effect of filgotinib compared to placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response in participants with active psoriatic arthritis who have an inadequate response or are intolerant to biologic disease-modifying anti-rheumatic drugs (DMARD) therapy.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	Filgotinib	Tablets will be administered orally once daily with or without food.
DRUG	Placebo to match filgotinib	Tablets administered orally once daily with or without food.

Timeline

• Start date: 2019-11-13
• Primary completion: 2021-01-04
• Completion: 2021-03-18
• First posted: 2019-10-04
• Last updated: 2022-03-18
• Results posted: 2022-03-18

Locations

59 sites across 11 countries: United States, Australia, Belgium, Canada, Czechia, Hungary, Japan, Poland, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study