AbbVie reports Phase III psoriasis data for IL-23 mAb risankizumab

AbbVie Inc. (NYSE:ABBV) said risankizumab (BI 655066) met the co-primary and all ranked secondary endpoints in 3 double-blind, international Phase III trials to treat moderate to severe chronic plaque psoriasis. The company did not respond to inquiries regarding next steps for the humanized IgG1 mAb that binds and neutralizes the p19 subunit of IL-23.

In the identical ultIMMa-1 and ultIMMa-2 trials, subcutaneous 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 75% of patients vs. 5% and 2% for placebo, respectively. In the same trials, 42% and 48% of patients receiving Stelara ustekinumab from Johnson & Johnson (NYSE:JNJ) achieved a PASI 90 response. On the second co-primary endpoint, risankizumab led to static Physician’s Global Assessment (sPGA) scores of clear or almost clear at week 16 in 88% and 84% of patients in ultIMMa-1 and ultIMMa-2, respectively, vs. 8% and 5% for placebo and 63% and 62% for Stelara. Patients received risankizumab at weeks 0 and 4 and then every 12 weeks...