Evaluation of the Predictive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Risankizumab and the Development of a Response-concentration Curve for Risankizumab in Patients With Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Development of the therapeutic window of risankizumab in psoriasis
研究概览
简要总结
Biologics such as risankizumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over-and undertreatment. In this study the investigators aim to investigate the predictive value of early serum trough levels of risankizumab and determine the therapeutic window of risankizumab in psoriasis patients.
详细描述
Patients will be included after signing informed consent. After inclusion, patients will continue on standard dosing schedule of risankizumab (i.e. subcutaneous injections at weeks 0 and 4, then every 12 weeks (2x 75mg)). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards risankizumab. In addition, Psoriasis Area and Severity Index (PASI) and 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 risankizumab
研究组 & 干预措施
Standard of care - risankizumab
Patients will continue to receive risankizumab according to the standard dosing schedule: subcutaneous injections at weeks 0 and 4, then every 12 weeks (2x 75mg).
干预措施: Venapuncture (Procedure)
Standard of care - risankizumab
Patients will continue to receive risankizumab according to the standard dosing schedule: subcutaneous injections at weeks 0 and 4, then every 12 weeks (2x 75mg).
干预措施: Patient questionnaires (Procedure)
结局指标
主要结局
Development of the therapeutic window of risankizumab in psoriasis
时间窗: Week 0 until week 52 of treatment
Defining a therapeutic window for risankizumab based on serum trough concentrations corresponding with adequate clinical response (ROC analysis and concentration-effect curve)
Predictive value of early serum trough concentrations of risankizumab
时间窗: Week 0 until week 24 of treatment
To assess the predictive value of early serum trough levels of risankizumab (µg/ml), the clinical response (PASI) at week 12 and/or week 24 will be correlated with serum trough concentrations of tildrakizumab measurements taken from week 0,1,2,3 and/or 4.
Predictive value of early anti-drug antibodies of risankizumab
时间窗: Week 0 until week 24 of treatment
To assess the predictive value of early anti-drug antibodies of risankizumab (µg/ml), the clinical response (PASI) at week 12 and/or week 24 will be correlated with anti-drug antibodies of tildrakizumab measurements taken from week 0,1,2,3 and/or 4.
次要结局
- EQ-5D-5L(Week 0 until week 52 of treatment)
- EQ VAS(Week 0 until week 52 of treatment)
- DLQI(Week 0 until week 52 of treatment)