GLPG0634: Phase IIb started

Galapagos began the double-blind, dose-escalation, international Phase IIb DARWIN 1 and DARWIN 2 trials of oral GLPG0634 in RA patients with inadequate response to methotrexate. DARWIN 1 will enroll 595 patients, who will receive 50, 100 or 200 mg once-daily GLPG0634 plus methotrexate; 25, 50 or 100 mg twice-daily GLPG0634 plus methotrexate; or placebo plus methotrexate for 24 weeks. DARWIN 2 will enroll 280 patients, who will receive placebo or 50, 100 or 200 mg once-daily GLPG0634 as monotherapy for 24 weeks. After 24 weeks, patients may receive GLPG0634 in the open-label DARWIN 3 extension study. Galapagos expects to complete enrollment in the Phase IIb DARWIN program in mid-2014, with 12-week top-line data slated for 4Q14. ...