JPRN-jRCT2080223954已完成2 期
A Randomized, Double-blind, Placebo-controlled Multicenter Dose Ranging Study to Assess the Safety and Efficacy of Multiple Oral ZPL389 Doses in Patients With Moderate to Severe Atopic Dermatitis (ZEST Trial)
ovartis Pharma K.K.0 个研究点目标入组 55 人开始时间: 2018年6月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
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
- •*Subjects must give a written, signed and dated informed consent
- •*Chronic atopic dermatitis present for at least 1 year before Baseline
- •*Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA
- •*Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable
- •*Candidate for systemic treatment
排除标准
- •*Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity
- •*Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer
- •*History of hypersensitivity to any of the study drug constituents or to drugs of similar chemical classes
- •*Participation in prior ZPL389 studies
- •Other protocol defined inclusion/exclusion may apply
研究者
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