EUCTR2019-000904-14-IT进行中（未招募）1 期
A Phase 3b, multicenter, interventional, open-label study of adult subjectswith moderate to severe plaque psoriasis who have a suboptimal response to secukinumab or ixekizumab and are switched to risankizumab. - RISA Raise Standard of Care Study M19-164
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •* Adult subjects 18 years and older at screening;
- •* Diagnosis of moderate to severe chronic plaque psoriasis for at least 6 months before Baseline (Week 0);
- •* Subject must have been on labeled secukinumab or ixekizumab treatment for at least 6 months and are experiencing a sub-optimal response at time of Screening and Baseline visits
- •* Sub-optimal response to Secukinumab and Ixekizumab inhibitors is defined as:
- •- Body Surface Area (BSA) 3% - <10% and
- •- Static Physician Global Assessment 2/3
- •* Subject must be eligible for continued biologic therapy as assessed by the investigator
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •* History of erythrodermic psoriasis, generalized or localized pustular
- •psoriasis, medication-induced or medication-exacerbated psoriasis, or
- •new onset guttate psoriasis, psoriatic arthritis;
- •* No active skin disease other than plaque psoriasis that could interfere
- •with the assessment of plaque psoriasis;
- •* History of chronic infections including HIV, viral hepatitis (hepatitis B,
- •hepatitis C), and/ or active tuberculosis. Subjects with a positive
- •QuantiFERON®-TB /PPD test result may participate in the study if
- •further work up (according to local
- •practice/guidelines) establishes conclusively that the subject has no
- •evidence of active tuberculosis. If presence of latent tuberculosis is
- •established, then treatment must have been initiated and maintained
- •according to local country guidelines;
- •* Active systemic infection during the last 2 weeks prior to Baseline Visit
- •(exception: common cold) as assessed by the investigator;
- •* History of any documented active or suspected malignancy or history
- •of any malignancy within the last 5 years except for successfully treated
- •non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the
- •* History of major surgery performed within 12 weeks prior to
- •randomization or planned to be performed during the conduct of the trial
- •as assessed by the investigator;
- •* Previous exposure to risankizumab or any IL-23 inhibitors.
研究者
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