Evaluation of the Predictive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Ixekizumab and the Development of Concentration-response Curve of Ixekizumab for Psoriasis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 14
- 主要终点
- Predictive value of early serum trough concentrations of ixekizumab
研究概览
简要总结
Biologics, such as ixekizumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis. But they are costly for health care systems and prescribed according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. Within this study the investigators aim to investigate the predictive value of early serum trough levels of ixekizumab and determine the therapeutic window of ixekizumab in psoriasis patients.
详细描述
Patients will be included after siging informed consent. After inclusion, patients will continue on standard dosing schedule of ixekizumab (i.e. one loading dose of 2 subcutaneous injections (160 mg) at week 0, followed by one subcutaneous injection (80 mg) every 2 weeks for 12 weeks, and then one subcutaneous injections (80 mg) every 4 weeks). During each study visit, blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards ixekizumab. In addition, the Psoriasis Severity and Area Index (PASI) and the Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
- •Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
排除标准
- •Participants who have currently a predominant nonplaque form of psoriasis
- •Participants who are pregnant, nursing or planning a pregnancy
- •Participants who are unable or unwilling to undergo multiple venapunctures
- •Participants who are treated according to a different dosing schedule than standard dosing of ixekizumab
结局指标
主要结局
Predictive value of early serum trough concentrations of ixekizumab
时间窗: Week 0 until week 24 of treatment
Prediction of the clinical response (PASI) at week 12 and/or week 24 based on serum trough concentrations measurements taken from week 0, 1, 2, 3 and/or 4.
Predictive value of early anti-drug antibodies of ixekizumab
时间窗: Week 0 until week 24 of treatment
Prediction of the clinical response (PASI) at week 12 and/or week 24 based on anti-drug antibodies measurements taken from week 0, 1, 2, 3 and/or 4.
The development of a therapeutic window of ixekizumab in psoriasis
时间窗: Week 0 until week 52 of treatment
Defining a therapeutic window for ixekizumab based on serum trough levels corresponding with adequate clinical response.
次要结局
- DLQI(Week 0 until week 52 of treatment)
- EQ5D5L(Week 0 until week 52 of treatment)
- EQ VAS(Week 0 until week 52 of treatment)