AbbVie planning risankizumab submissions in psoriasis

AbbVie Inc. (NYSE:ABBV) plans to submit worldwide regulatory applications in 2018 for risankizumab (BI 655066) to treat moderate to severe plaque psoriasis after the candidate met the co-primary and all ranked secondary endpoints in a fourth Phase III trial for the indication.

In the first portion of the Phase III IMMhance trial, subcutaneous 150 mg risankizumab led to ≥90% skin clearance as measured by the Psoriasis Area and Severity Index (PASI 90) at week 16, the first co-primary endpoint, in 73% of patients vs. 2% for placebo (p<0.001). On the second co-primary endpoint, risankizumab led to a static Physician’s Global Assessment (sPGA) score of clear or almost clear at week 16 in 84% of patients vs. 7% for placebo (p<0.001). In the double-blind, international trial, patients received placebo or risankizumab at weeks 0 and 4, and then every 12 weeks. At week 16, patients in the placebo arm were switched to risankizumab...