A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

UCB Japan Co., Ltd.1 个研究点目标入组 100 人开始时间: 待定最近更新: 2022年4月21日

试验速览

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研究类型: Interventional
干预模型: Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study
主要目的: Treatment Purpose

•Must be at least 18 years of age
•Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit
•Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale
•Subject is a candidate for systemic PSO therapy and/or phototherapy
•Female subject of child bearing potential must be willing to use highly effective method of contraception

•Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic or recurrent chronic infections
•Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
•Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
•Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
•Presence of active suicidal ideation or positive suicide behavior
•Presence of moderately severe major depression or severe major depression
•Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

发起方

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