JPRN-jRCT2080225270已完成3 期
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
CB Japan Co., Ltd.0 个研究点目标入组 567 人开始时间: 2020年7月9日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 567
研究概览
简要总结
567 were enrolled and randomly assigned (bimekizumab 320 mg Q4W group n=321, ustekinumab group n=163, placebo group n=83). At week 16, 85% and 84% in the bimekizumab 320 mg Q4W group had PASI90 response and IGA response. Over 52 weeks, serious treatment-emergent adverse events were reported in 24 (6%) of 395 patients in the bimekizumab group (including those who switched from placebo to bimekizumab 320 mg Q4W at week 16).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •- 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
研究者
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