JPRN-jRCT2080224002已完成3 期
A multicenter, open-label study to assess the long-term safety, torelability, and efficacy 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 160 人开始时间: 2018年8月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
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
- •[Cohort A]
- •- Female subjects who plan to become pregnant during the study
- •- Subject has a positive or indeterminate IGRA in a feeder study, unless appropriately evaluated and treated
- •[Cohort B]
- •- Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
- •- Subject has guttate PSO or drug-induced PSO
- •- Subject has an active infection or history of infections
- •- Subject has known TB infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
- •- Subject has a diagnosis of inflammatory conditions other than PSO, PsA, GPP, or EP, including but not limited to rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, Crohn's disease, or ulcerative colitis
- •- Subject has GPP or EP
- •- Subject has experienced primary failure (no response within 12 weeks) to 1 or more IL-17 biologic response modifier (eg, brodalumab, ixekizumab, secukinumab) OR more than 1 biologic response modifier other than an IL-17
- •- Subject has a differential diagnosis of the erythroderma (eg, erythroderma caused by lymphoma or drug eruption) other than EP
- •- Subject with a primary failure to any prior biologic therapy (primary failure defined as no response within the first 12 weeks of treatment with the biologic)
排除标准
- •[Cohort A]
- •- Female subjects who plan to become pregnant during the study
- •- Subject has a positive or indeterminate IGRA in a feeder study, unless appropriately evaluated and treated
- •[Cohort B]
- •- Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
- •- Subject has guttate PSO or drug-induced PSO.
- •- Subject has an active infection or history of infections
- •- Subject has known TB infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.
- •- Subject has a diagnosis of inflammatory conditions other than PSO, PsA, GPP, or EP, including but not limited to rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, Crohn's disease, or ulcerative colitis.
- •- Subject has GPP or EP
- •- Subject has experienced primary failure (no response within 12 weeks) to 1 or more IL-17 biologic response modifier (eg, brodalumab, ixekizumab, secukinumab) OR more than 1 biologic response modifier other than an IL-17.
- •- Subject has a differential diagnosis of the erythroderma (eg, erythroderma caused by lymphoma or drug eruption) other than EP
- •- Subject with a primary failure to any prior biologic therapy (primary failure defined as no response within the first 12 weeks of treatment with the biologic).
研究者
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