The approval is based on data from two large, pivotal Phase III, multi-center, randomized, double-blind, placebo controlled trials, Phoenix 1 & 2, involving nearly 2,000 patients in whom the efficacy and safety of ustekinumab in the treatment of moderate-to-severe plaque psoriasis were evaluated.
The approved indication of Stelara (ustekinumab) is for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen plus ultraviolet A light.