Galapagos Readies Two Clinical Trials To Advance Filgotinib as IBD Treatment

Galapagos Readies Two Clinical Trials To Advance Filgotinib as IBD Treatment
Galapagos has completed discussions with U.S. and European regulatory authorities to begin the DIVERSITY Phase 3 clinical trial (NCT02914561) in patients with Crohn's disease and the SELECTION Phase 2b/3 study (NCT02914522) in ulcerative colitis with filgotinib. Filgotinib is a selective inhibitor of the JAK1 (Janus kinase 1), an enzyme involved in the signaling pathways of several pro-inflammatory cytokines, ultimately leading to inflammation. It is the first JAK inhibitor to show efficacy in Crohn’s disease, a disease that still has few treatment options. Both trials will assess the efficacy and safety of filgotinib (100 mg and 200 mg once daily) versus placebo in patients with moderate-to-severe active Crohn’s disease, either anti-TNF naive or anti-TNF failures. Neither trial is recruiting patients yet, but the company expects to administer the first doses to patients later this year. A population of 1.300 patients for each study will be recruited from the U.S., Europe, Latin America, Canada, and Asia/Pacific. The SELECTION trial  in patients with ulcerative colitis will involve a futility analysis, which will serve as the Phase 2b part of the study. In the U.S., men will be treated with 200 mg of filgotinib if they failed at least one anti-TNF, and vedolizumabThe Phase 3 progra
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