BI 655066/ABBV-066 (risankizumab) versus Ustekinumab andplacebo comparators in a randomized double blind trIal forMaintenance use in Moderate to severe plaque type psoriasis(UltIMMa-1) - UltIMMa-1

Boehringer Ingelheim Pharma GmbH & Co. KG0 个研究点目标入组 500 人开始时间: 2015年12月16日最近更新: 2017年11月6日

研究概览

暂无简介。

•Male or female patients with age = 18 years at screening.
•Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.
•Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomisation):
•-Have an involved body surface area (BSA) = 10% and
•-Have a Psoriasis Area and Severity Index (PASI) score = 12 and
•- Have a static Physician Global Assessment (sPGA) score of = 3.
•Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator.
•Must be a candidate for treatment with Stelara® (ustekinumab) according to local label.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 425
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 75

•Patients with
•a. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
•b. current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
•c. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator¿s judgment
•Previous exposure to BI 655066
•Previous exposure to ustekinumab (Stelara®)

发起方