drugset
drugset / Trial / NCT04115748

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

NCT04115748 ↗

Phase 3 Terminated 67 enrolled Gilead Sciences Lakefront Biotherapeutics NV · collab
RandomizedParallel-groupDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 40 mg Subcutaneous
Subject Filgotinib Small molecule 100 mg Oral
Subject Filgotinib Small molecule 200 mg Oral

Indications

psoriatic arthritis