Galapagos NV has started two new Phase 2 studies of filgotinib in small bowel Crohn`s disease and in fistulizing Crohn`s disease, both led by filgotinib collaboration partner Gilead Sciences.
Both studies are multi-center, randomized, double-blind, placebo-controlled studies.
The first additional Crohn`s disease Phase 2 study is testing the investigational selective JAK1 inhibitor filgotinib in adult patients with small bowel Crohn`s disease. It is planned to get 100 patients in North America and Europe to receive one of two doses of filgotinib or placebo, administered for 24 weeks. The main goal of the study is comparing filgotinib to placebo at week 24.
The second study will test the selective JAK1 inhibitor filgotinib in adult patients with perianal fistulizing Crohn`s disease with about 75 patients planned to be randomized to get one of two doses of filgotinib or placebo administered for 24 weeks. The primary objective is to compare filgotinib to placebo, in establishing a combined fistula response at week 24.
Furthermore, the new Phase 2 studies with filgotinib come after starting the DIVERSITY Phase 3 study in Crohn`s disease. Gilead further initiated the FINCH Phase 3 program in rheumatoid arthritis and the SELECTION Phase 2b/3 study in ulcerative colitis in 2016.