NCT03587805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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 1,672
- 试验地点
- 3
- 主要终点
- Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268)
研究概览
简要总结
The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341, -1342, -1343, -1346, or TRA-WEI-0015-I.
- •Complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
- •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 corticosteroid within 4 weeks prior to baseline.
- •Treatment with topical phosphodiesterase 4 inhibitors or topical JAK inhibitors within 2 weeks prior to baseline.
- •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.
研究组 & 干预措施
Tralokinumab, all subjects
Experimental
Week 0: subcutaneous (SC) injection of tralokinumab loading dose. From Week 2 up to Week 266: SC injection of tralokinumab maintenance dose. The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.
干预措施: Tralokinumab (Drug)
结局指标
主要结局
Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268)
时间窗: From Week 0 up to Week 268
次要结局
- Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248(From Week 16 up to Week 248)
- At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248(From Week 16 up to Week 248)
研究者
研究点 (3)
Loading locations...
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