Date: 2017-04-04
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
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: ankylosing spondylitis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial details: This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with active Ankylosing Spondylitis (AS). A total of approximately 100 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo q.d. Treatment duration will be 12 weeks. Each subject will stay in the study for a maximum of 20 weeks (from Screening visit to Follow-up visit). (NCT03117270)
Latest news: • On April 4, 2017, Galapagos announced a new Phase 2 Proof-of-Concept study investigating filgotinib in ankylosing spondylitis. The study is being led by Galapagos.
