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

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).

Timeline

Start

2019-12-03

Primary completion

2021-01-19

Completion

2021-05-11

Outcome

Met primary endpoint

Stopped: “Development program terminated”

registry analysis (superiority test); Filgotinib 200 mg (Main Study) vs Placebo (Main Study); p = 0.048; Difference in response rates 32.1 (95% CI 2.6 to 61.6) NCT04115748 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Subject	Filgotinib	Small molecule	100 mg	Oral
Subject	Filgotinib	Small molecule	200 mg	Oral

Indications