NCT04115748

Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy

A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 67 (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 are naive to biologic disease-modifying anti-rheumatic drug (DMARD) therapy. The study consists of two parts, the Main Study and the Long Term Extension (LTE).

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	Filgotinib	Tablets administered orally once daily with or without food
DRUG	Adalimumab	Injection administered subcutaneously once every 2 weeks
DRUG	Placebo to match filgotinib	Tablets administered orally once daily with or without food
DRUG	Placebo to match adalimumab	Injection administered subcutaneously once every 2 weeks

Timeline

• Start date: 2019-12-03
• Primary completion: 2021-01-19
• Completion: 2021-05-11
• First posted: 2019-10-04
• Last updated: 2022-05-16
• Results posted: 2022-05-16

Locations

74 sites across 13 countries: United States, Australia, Bulgaria, Canada, Czechia, Hungary, Japan, New Zealand, Poland, Russia, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study