Date: 2017-04-05
Type of information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: Galapagos (Belgium)
Product: filgotinib
Action mechanism: janus kinase inhibitor. Filgotinib is an orally-available, novel Janus kinase (JAK) inhibitor with selectivity for JAK1 developed by Galapagos. JAKs are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in rheumatoid arthritis patients. JAK inhibitors have shown long-term efficacy in rheumatoid arthritis studies with an early onset of action. Filgotinib differentiates from other JAK inhibitors in development by specifically targeting JAK1, a strategy which could result in a better efficacy and safety profile. Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications.
Disease: psoriatic arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country: Estonia
Trial details: The EQUATOR study is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with moderately to severely active psoriatic arthritis 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). (NCT03101670)
Latest news: • On April 5, 2017, Galapagos announced dosing of the first patient with psoriatic arthritis in the EQUATOR Phase 2 study. This achievement triggers a $10 million milestone payment from Gilead to Galapagos. The EQUATOR Phase 2 study will be a multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of the selective JAK1 inhibitor filgotinib in adult patients with moderately to severely active psoriatic arthritis. Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. In addition to the EQUATOR Phase 2 study in psoriatic arthritis and the TORTUGA Phase 2 study in ankylosing spondylitis led by Galapagos, Gilead initiated the FINCH Phase 3 program in rheumatoid arthritis, the DIVERSITY Phase 3 study in Crohn's disease, the SELECTION Phase 2b/3 study in ulcerative colitis in 2016 and leads the Phase 2 study in Sjögren's syndrome. • On April 4, 2017, Galapagos announced a new Phase 2 Proof-of-Concept study investigating filgotinib in psoriatic arthritis. The study is being led by Galapagos.
