Study design and treatment
Psoriasis
PSORIASIS
IMMspire (A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis) (NCT03022045) was a phase 3, randomized, open‐label, parallel‐design study that compared two different doses of risankizumab in patients with GPP or EP. After screening, patients were randomized 1:1 to receive subcutaneous administration of open‐label risankizumab 150 mg or 75 mg at week 0 and week 4 and every 12 weeks thereafter through week 160. After marketing approval of risankizumab in Japan, the approved dosage and administration (risankizumab 150 mg at week 0 and week 4 and every 12 weeks thereafter [75 mg may be acceptable for some patients according to their condition]) was followed; no dose adjustments were made after approval. At week 16, patients who failed to achieve clinical response with risankizumab 75 mg were allowed to increase the dose to 150 mg. One follow‐up visit was conducted 20 weeks after the last administration of the study drug. This clinical study was conducted in accordance with the protocol, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines, and applicable guidelines and regulations governing ethical principles originating in the Declaration of Helsinki. An independent ethics committee/institutional review board ensured the ethical, scientific, and medical appropriateness of the study before it was conducted and approved all relevant documentation.