Galapagos Begins Phase 2b/3 Clinical Trial of Filgotinib in Ulcerative Colitis Patients

Galapagos Begins Phase 2b/3 Clinical Trial of Filgotinib in Ulcerative Colitis Patients
Galapagos NV recently announced that it has dosed the first patient with ulcerative colitis (UC) in its SELECTION Phase 2b/3 clinical trial, investigating the efficacy and safety of two doses of filgotinib as a UC treatment. SELECTION  (NCT02914522) is investigating two doses of filgotinib (100 mg and 200 mg filgotinib once daily), compared to placebo, as an induction and maintenance treatment for people with moderately to severely active ulcerative colitis. The trial is currently recruiting participants, including those who have failed to respond to previous treatments with biologics. In total, about 1,300 patients will be recruited from across the U.S., Europe, Latin America, Canada, and Asia/Pacific. This trial will include an interim analysis, which will serve as its Phase 2b part. Its primary goal is the proportion of patients achieving remission, based on Mayo Clinic Score components, at week 10 in the study's induction phase, and the proportion achieving remission at week 58 in its maintenance phase. In the U.S., men will be treated with 200 mg of filgotinib if they failed at least one previous biological therapy. The Phase 3 program of filgotinib also will incorporate a testicular safety analysis. The trial's initiation triggered a $10 million milestone payment from Gilead Sciences to Galapagos. The companies are collaborating in the development and commercialization of filgotinib in multiple inflammatory indications. In addition to SELECTION, Galapagos is conducting DIVERSITY, a Phase 3 clinical trial (
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