JPRN-jRCT2031200162已完成3 期
A randomised, double blind, placebo controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids in Japanese subjects with moderate to severe atopic dermatitis who are candidates for systemic therapy
Kato Norito0 个研究点目标入组 106 人开始时间: 2020年10月16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
- 106
研究概览
简要总结
Primary objective: To evaluate the efficacy of tralokinumab in combination with topical corticosteroids (TCS) compared with placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD). Secondary objectives: To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, health-related quality of life, and health care resource utilisation compared with placebo in combination with TCS. To assess the safety of tralokinumab in combination wit
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
- •Japanese subject aged 18 years and above.
- •- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
- •- History of AD for 1 year or more.
- •- A recent history (within 1 year before screening) of inadequate response to treatment with topical medication.
- •- AD involvement of 10% or more body surface area at screening and at baseline according to component A of SCORAD.
- •- Applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.
排除标准
- •- Subjects for whom TCS are medically inadvisable e.g. due to important side effects or safety risks in the opinion of the investigator.
- •- Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
- •- Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
- •- Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 4 weeks prior to randomisation.
- •- Treatment with TCS, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to randomisation.
- •- Receipt of any marketed biological therapy (i.e. immunoglobulin, antiimmunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to randomisation.
- •- Active skin infections within 1 week prior to randomisation
- •- Clinically significant infection within 4 weeks prior to randomisation
- •A helminth parasitic infection within 6 months prior to the date informed consent is obtained
- •- Tuberculosis requiring treatment within the 12 months prior to screening
- •- Known primary immunodeficiency disorder
研究者
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