jRCT2080224092已完成3 期
An open-label, single-arm, multi-centre, long-term extension trial to evaluate the safety and efficacy of tralokinumab in subjects with atopic dermatitis who participated in previous tralokinumab clinical trials.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- The trial will include a screening period of 2 weeks (Week 2 to Week 0), a long-term treatment period of approximately 0.5 to 2.5 years, and a 14-week follow-up period for assessment of safety and immunogenicity. The duration of the treatment period for each subject will depend on when they enter the trial after completing the parent trial.
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 12age old over 至 No limit（—）
- 性别
- All
入选标准
- •Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341, -1342, or -
- •Able and willing to self-administer tralokinumab treatment (or have it administered by a caregiver) at home after the initial 3 injection visits at the trial site (in this trial).
- •Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.
排除标准
- •Any condition that required permanent discontinuation of trial treatment in the parent trial.
- •More than 26 weeks have elapsed since the subject received the last injection of investigational medicinal product (IMP) in the parent trial (to be assessed at baseline).
- •Subjects who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to tralokinumab by the investigator, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject.
- •Subjects who, during their participation in the parent trial, developed an AE that was deemed related to tralokinumab by the investigator and led to temporary discontinuation of trial treatment, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject.
- •Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 5 half-lives prior to baseline.
- •Treatment with topical phosphodiesterase 4 inhibitors within 2 weeks prior to baseline.
- •Receipt of any marketed biological therapy (that is, immunoglobulin or anti-immunoglobulin E) including dupilumab or investigational biologic agents
- •Clinically significant infection within 4 weeks prior to baseline.
- •A helminth parasitic infection within 6 months prior to the date when informed consent is obtained.
- •Tuberculosis requiring treatment within 12 months prior to screening.
- •Known primary immunodeficiency disorder.
结局指标
主要结局
-
safety Number of adverse events during the treatment period from baseline up to Week 268
次要结局
- Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear)(From Week 16 up to Week 128)
- At least 75% reduction in Eczema Area and Severity Index (EASI75) relative to baseline in parent trial(From Week 16 up to Week 128)
研究者
研究点 (1)
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