A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2 - AMAGINE-2

Amgen Inc.0 个研究点目标入组 1,800 人开始时间: 2012年5月17日最近更新: 2016年3月14日

研究概览

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•- Subject has provided informed consent.
•- Subject is = 18 and = 75 years of age at time of screening.
•- Subject has had stable moderate to severe plaque psoriasis for at least 6 months before first dose of IP (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator).
•- Subject must be considered, in the opinion of the investigator, to be a suitable candidate for treatment with a biologic per regional labeling.
•- Subject has involved body surface area (BSA) = 10%, PASI = 12, and sPGA = 3 at screening and at baseline.
•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 1710
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 90

•- Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the investigator to be clinically significant and uncontrolled.
•- Subject has any concurrent medical condition that, in the opinion of the
•investigator, could cause this study to be detrimental to the subject.
•- Subject has used ustekinumab and/or anti-IL-17 biologic therapy ever or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.
•- Subject currently is enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s).
•- Other investigational procedures are excluded.
•- Subject has known sensitivity to any of the products or components to be
•administered during dosing.
•- For women: pregnant or breast feeding, or planning to become pregnant while enrolled in the study and for 15 weeks after the last dose (if discontinuing before week 52) or for 8 weeks after the last dose (if discontinuing at or after week 52).

发起方

Amgen Inc.