New Phase 2 Trials to Evaluate Filgotinib in Two Types of Crohn’s Disease

New Phase 2 Trials to Evaluate Filgotinib in Two Types of Crohn’s Disease
Galapagos NV, collaborating with Gilead Sciences, will soon begin recruiting for  announced two new Phase 2 clinical trials to evaluate filgotinib in patients with small bowel Crohn’s disease, as well as in patients with fistulizing Crohn’s disease. Galapagos and Gilead Sciences have a global partnership for the development and commercialization of filgotinib for inflammatory diseases. Filgotinib is a selective inhibitor of the JAK1 (Janus kinase 1) inhibitor, an enzyme involved in the signaling pathways of several pro-inflammatory cytokines — proteins which ultimately lead to inflammation. The drug is the first JAK inhibitor to show effectiveness in Crohn’s, but it is still in investigational stages and has not been approved for any indication. The first additional Crohn’s disease study is a Phase 2, double-blind, randomized, placebo-controlled clinical trial (NCT03046056) evaluating the effectiveness and safety of filgotinib in the treatment of small bowel Crohn's disease (SBCD). Approximately 100 patients in North America and Europe will be randomly assigned to treatment with two doses of filgotinib or a placebo, administered for 24 weeks. The trial's primary endpoint is the proportion of patients achieving clinical remission after 24 weeks of treatment compared to a placebo. Clinical remission will be determined as a score below 150 in the Crohn's Disease Activity Index (CDAI).
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