BioCentury
ARTICLE | Clinical News

CHS-0214: Phase III data

November 16, 2015 8:00 AM UTC

The double-blind, international Phase III RaPsOdy (CHS-0214-04) trial in about 496 patients with moderate to severe chronic plaque psoriasis who are naive to systemic biologic therapy showed that 50 mg subcutaneous CHS-0214 met the co-primary endpoints of demonstrating equivalence to 50 mg Enbrel etanercept in the mean percent change in PASI from baseline to week 12 and the proportion of patients achieving a PASI 75 response at week 12. There were no clinically meaningful differences in the safety profiles between treatment arms. The first part of CHS-0214-04 compared twice-weekly CHS-0214 vs. twice-weekly Enbrel for 12 weeks. The second part of the trial is comparing once-weekly CHS-0214 vs. once-weekly Enbrel for 40 weeks. ...