EUCTR2016-003046-87-FR进行中（未招募）1 期
A multicenter, open Label study to assess the safety and efficacy of rIsankizuMab for MaInTenance in moderate to severe pLaquE type pSoriaSis (LIMMITLESS)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subjects with a history of moderate to severe chronic plaque psoriasis, who have completed preceding Study 1311.13.
- •2. Females of childbearing potential must have a negative urine pregnancy test result at Baseline.
- •If female, subject must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential practicing at least one protocol specified method of birth control (Section 5.2.4), starting at Baseline through at least 20 weeks after the last dose of study drug.
- •3. Subjects must have signed and dated a written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission into the study.
- •2. Subjects must be candidates for prolonged open label risankizumab treatment according to investigator judgment
- •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 1675
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 325
排除标准
- •1. Premature discontinuation for any reason in the preceding study.
- •2. Subjects who have developed guttate, erythrodermic, pustular or drug-induced psoriasis as diagnosed by the investigator during the preceding study.
研究者
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