EUCTR2017-004515-39-EE进行中（未招募）1 期
A randomized, open-label, multicenter trial to assess theefficacy of subcutaneous secukinumab after twelve weeksof treatment, and to assess the long-term safety,tolerability and efficacy in subjects from 6 to less than 18years of age with moderate to severe chronic plaquepsoriasis.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
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
- •1. Written informed assent and parental permission (age as per local law) obtained at screening before any assessment is performed.
- •2. Must be 6 to less than 18 years of age at the time of randomization
- •3. Moderate to Severe plaque psoriasis, defined as a PASI score = 12, and IGA mod 2011 score of = 3, and BSA involvement of =10%, at randomization.
- •4. History of plaque psoriasis for at least 3 months before randomization
- •5. Subject being regarded by the investigator to be a candidate for systemic therapy.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 80
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects fulfilling any of the following criteria:
- •1. Forms of psoriasis other than chronic plaque-type active at randomization
- •2. Drug-induced psoriasis
- •3. Ongoing use of prohibited treatments
- •4. Female subjects of childbearing potential defined as all women
- •physiologically capable of becoming pregnant, unless they are using
- •effective methods of contraception during dosing and for 16 weeks after
- •stopping study treatment
- •5. Pregnant or nursing (lactating) females
- •6. Subjects with total WBC count <2,500/µL, or platelets <100,000/µL
- •or neutrophils <1,500/µL or hemoglobin <8.5 g/dL at screening
- •7. Previous exposure to secukinumab or any other biologic drug directly
- •targeting IL-17 or the IL-17 receptor
研究者
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