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

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).

Timeline

Start

2017-03-09

Primary completion

2018-03-12

Completion

2018-03-12

Outcome

Met primary endpoint

paper 52 (80%) of 65 patients in the filgotinib group and 22 (33%) of 66 in the placebo group achieved ACR20 at week 16 PMID 30360969 ↗

paper treatment difference 47% [95% CI 30·2-59·6], p<0·0001 PMID 30360969 ↗

release “EQUATOR study of filgotinib, an investigational, selective JAK1 inhibitor, in 131 adults with moderate to severe psoriatic arthritis, achieved its primary endpoint” lakefrontbio.com ↗

release “Phase 2 EQUATOR study of filgotinib, an investigational, selective JAK1 inhibitor, in 131 adults with moderate to severe psoriatic arthritis, achieved its primary endpoint” gilead.com ↗

Publications

• Chandran V, Malkov VA, Ito KL, Liu Y, Vestergaard L, Yoon OK, Liu J, Trivedi M, Hertz A, Gladman D. Pharmacodynamic effects of filgotinib treatment driving clinical improvement in patients with active psoriatic arthritis enrolled in the EQUATOR trial. RMD Open. 2023 Nov;9(4):e003550. doi: 10.1136/rmdopen-2023-003550.
• Orbai AM, Ogdie A, Gossec L, Tillett W, Leung YY, Gao J, Trivedi M, Tasset C, Meuleners L, Besuyen R, Hendrikx T, Coates LC. Effect of filgotinib on health-related quality of life in active psoriatic arthritis: a randomized phase 2 trial (EQUATOR). Rheumatology (Oxford). 2020 Jul 1;59(7):1495-1504. doi: 10.1093/rheumatology/kez408.
• Mease P, Coates LC, Helliwell PS, Stanislavchuk M, Rychlewska-Hanczewska A, Dudek A, Abi-Saab W, Tasset C, Meuleners L, Harrison P, Besuyen R, Van der Aa A, Mozaffarian N, Greer JM, Kunder R, Van den Bosch F, Gladman DD. Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active psoriatic arthritis (EQUATOR): results from a randomised, placebo-controlled, phase 2 trial. Lancet. 2018 Dec 1;392(10162):2367-2377. doi: 10.1016/S0140-6736(18)32483-8. Epub 2018 Oct 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Filgotinib	Small molecule	200 mg	Oral

Indications