EUCTR2017-004932-12-DE进行中（未招募）1 期
A Multicenter, Randomized, Open Label, Efficacy Assessor-Blinded Study of Risankizumab Compared to Secukinumab for the Treatment of Adult Subjects with Moderate to Severe Plaque Psoriasis who are Candidates for Systemic Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 310
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. Laboratory values meeting the following criteria within the screening period prior to the first dose of study drug:
- •Serum aspartate transaminase (AST) < 2 × ULN;
- •Serum alanine transaminase (ALT) < 2 × ULN;
- •Serum direct bilirubin = 2.0 mg/dL; except for subjects with isolated elevation of indirect bilirubin relating to a confirmed diagnosis of Gilbert syndrome;
- •Total white blood cell (WBC) count > 3,000/µL;
- •Absolute neutrophil count (ANC) > 1,500/µL;
- •Platelet count > 100,000/µL;
- •Hemoglobin > 8 g/dL.
- •2. Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the Baseline Visit;
- •3. Subject has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis
- •Subject has = 10% BSA psoriasis involvement, sPGA score of = 3, and PASI = 12 at Screening and Baseline Visit;
- •4. Subject must be a candidate for systemic therapy as assessed by the investigator;
- •5. Subject must be an acceptable candidate to receive secukinumab according to the local label for this compound.
- •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 233
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 77
排除标准
- •1. No history of:
- •Erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis;
- •Active skin disease other than psoriasis that could interfere with the assessment of psoriasis;
- •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. The patient will not be eligible for randomization if latent tuberculosis is present and is untreated as per local guidelines.
- •Active systemic infection during the last 2 weeks prior to Baseline Visit (exception: common cold) prior to Baseline Visit, as assessed by the investigator;
- •2. No 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 cervix;
- •3. No previous exposure to risankizumab;
- •4. No previous exposure to secukinumab;
- •5. Subject must not have been treated with any investigational drug within 30 days or 5 half lives of the drug (whichever is longer) prior to the first dose of study drug or currently be enrolled in another clinical study.
研究者
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