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 - OASIS-1

Eli Lilly and Company0 个研究点目标入组 500 人开始时间: 2018年3月7日最近更新: 2020年3月18日

适应症

试验速览

暂无简介。

•- Present with chronic plaque psoriasis:
•A. Plaque psoriasis involving =10% body surface area and absolute PASI score =12 in affected skin
•B. sPGA score of =3
•- Candidate for systemic therapy and/or phototherapy
•- Female patients must test negative for pregnancy prior to initiation of treatment and agree to use contraception
•- Are =18 years of age
•- Have adequate organ function
•- Have given written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 450
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•- Have an unstable or uncontrolled illness
•- Presence of significant uncontrolled neuropsychiatric disorder
•- Have human immunodeficiency virus, acquired immune deficiency syndrome, or test positive human HIV antibodies at screening
•- Have hepatitis C or test positive for hepatitis C virus at screening
•- Have hepatitis B or test positive for hepatitis B virus at screening
•- Are women who are breastfeeding or plan to breastfeed during study
•- Have received systemic nonbiologic therapy within 28 days prior to baseline
•- Have received topical treatment within 14 days prior to baseline
•- Have received anti-TNF targeting biologics within 8 weeks prior to baseline, or anti-IL-17 targeting biologics within 12 weeks prior to baseline
•- Have previous exposure to any biologic therapy targeting IL-12/23 or IL-23

发起方