PER-031-18已完成未知
A RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL TO ASSESS THE EFFICACY OF SUBCUTANEOUS SECUKINUMAB AFTER TWELVE WEEKS OF TREATMENT, AND TO ASSESS THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY IN SUBJECTS FROM 6 TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2018年12月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Must be 6 to less than 18 years of age at the time of randomization.
- •2. 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
- •3. History of plaque psoriasis for at least 3 months before randomization
排除标准
- •1. Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate psoriasis), active at randomization.
- •2. Drug-induced psoriasis (ie new onset or current exacerbation from beta-blockers, calcium channel blockers or lithium)
- •3. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor,
- •4. Subjects with an estimated Glomerular Filtration Rate (eGFR), estimated by the Schwartz equation, of < 60 mL/min/1.73 m2 at screening. Assessment may be repeated once, two or more days later, and if eGFR value 60, subject may be included at the discretion of the investigator.
研究者
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