NCT03101670: EQUATOR

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

Completed Phase 2 Last updated 23 April 2018

What this trial tests

Phase 2 trial testing filgotinib in Psoriatic Arthritis in 131 participants. Completed in 12 March 2018.

Timeline

9 March 2017

Primary endpoint
12 March 2018

12 March 2018

Quick facts

Lead sponsor	Galapagos NV
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	131
Start date	9 March 2017
Primary completion	12 March 2018
Estimated completion	12 March 2018
Sites	25 locations across Ukraine, Belgium, Estonia, Poland, Bulgaria, Spain, Czechia

Drugs / interventions tested

• filgotinib (FILGOTINIB) — full drug profile →
• Placebo Oral Tablet — full drug profile →

Conditions studied

• Psoriatic Arthritis — all drugs for Psoriatic Arthritis →

Sponsor

Galapagos NV — full company profile →

Who can join

18 and older, any sex, with Psoriatic Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. JAK-inhibitors. New players in the field of immune-mediated diseases, beyond rheumatoid arthritis.
   Fragoulis GE, McInnes IB, Siebert S. · · 2019 · cited 223× · PMID 30806709 · DOI 10.1093/rheumatology/key276
2. A Comprehensive Overview of Globally Approved JAK Inhibitors.
   Shawky AM, Almalki FA, Abdalla AN, Abdelazeem AH, et al · · 2022 · cited 222× · PMID 35631587 · DOI 10.3390/pharmaceutics14051001
3. JAK/STAT pathway: Extracellular signals, diseases, immunity, and therapeutic regimens.
   Hu Q, Bian Q, Rong D, Wang L, et al · · 2023 · cited 190× · PMID 36911202 · DOI 10.3389/fbioe.2023.1110765
4. 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.
   Mease P, Coates LC, Helliwell PS, Stanislavchuk M, et al · · 2018 · cited 154× · PMID 30360969 · DOI 10.1016/s0140-6736(18)32483-8
5. Small molecules to the rescue: Inhibition of cytokine signaling in immune-mediated diseases.
   Gadina M, Gazaniga N, Vian L, Furumoto Y. · · 2017 · cited 60× · PMID 28676205 · DOI 10.1016/j.jaut.2017.06.006
6. Filgotinib: First Approval.
   Dhillon S, Keam SJ. · · 2020 · cited 59× · PMID 33237566 · DOI 10.1007/s40265-020-01439-0
7. Jakinibs of All Trades: Inhibiting Cytokine Signaling in Immune-Mediated Pathologies.
   Alexander M, Luo Y, Raimondi G, O'Shea JJ, et al · · 2021 · cited 27× · PMID 35056105 · DOI 10.3390/ph15010048
8. Effect of filgotinib on health-related quality of life in active psoriatic arthritis: a randomized phase 2 trial (EQUATOR).
   Orbai AM, Ogdie A, Gossec L, Tillett W, et al · · 2020 · cited 22× · PMID 31624837 · DOI 10.1093/rheumatology/kez408