A Multicenter Study with a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Withdrawal Maintenance Dosing Period to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderate-to-Severe Plaque Psoriasis OASIS-1

Eli Lilly Japan K.K.0 个研究点目标入组 50 人开始时间: 2018年6月8日最近更新: 2023年10月17日

研究概览

暂无简介。

•Present with chronic plaque psoriasis for at least 6 months prior to baseline and meet the following criteria: plaque psoriasis involving >=10% BSA, PASI score >=12, sPGA score of >=3

•-Have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal laboratory values at screening, that in the opinion of the investigator, would potentially affect participant safety within the study or of interfering with the interpretation of data.
•-Breastfeeding or nursing women.
•-Have had serious, opportunistic, or chronic/recurring infection within 3 months prior to screening.
•-Have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or received live vaccine(s) (including attenuated live vaccines) within 12 weeks of baseline or intend to receive either during the study.
•-Have any other skin conditions (excluding psoriasis) that would affect interpretation of the results.
•-Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days prior to baseline.
•-Have received topical psoriasis treatment within 14 days prior to baseline.
•-Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17 targeting biologics within 12 weeks prior to baseline.
•-Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational.

发起方