Galapagos has announced a new Phase 2 study investigating filgotinib in non-infectious uveitis, being led by filgotinib collaboration partner Gilead Sciences, Inc.
“We are pleased with the initiation of this new Phase 2 study with filgotinib,” said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos. “We look forward to seeing the study results which will show whether filgotinib has the potential to impact signs and symptoms of non-infectious uveitis, a group of inflammatory diseases carrying significant visual morbidities.”
The Phase 2 study will be a multi-center, randomized, double-masked, placebo-controlled study to assess the safety and efficacy of filgotinib in adult patients with active, non-infectious uveitis. Approximately 110 patients are planned to be randomized in the study to receive filgotinib or placebo administered for 52 weeks. The primary goal is to evaluate the efficacy and safety of filgotinib versus placebo for the treatment of non-infectious intermediate-, posterior- or pan-uveitis. The primary outcome is measured by the proportion of subjects failing treatment by week 24; treatment failure is representative of an active uveitis flare.
Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. This study is an addition to the ongoing Phase 2 studies in cutaneous lupus erythematosus, Sjögren’s syndrome, ankylosing spondylitis and psoriatic arthritis, as well as the ongoing Phase 3 program in rheumatoid arthritis, the Phase 3 study in Crohn’s disease (also Phase 2 in small bowel and fistulizing Crohn’s disease), and Phase 2b/3 study in ulcerative colitis.
