EUCTR2008-007525-39-FR进行中（未招募）不适用
A randomized, double-blind, placebo controlled, multicenter regimen finding study of subcutaneously administered AIN457, assessing Psoriasis Area and Severity Index (PASI) response in patients with moderate to severe chronic plaque-type psoriasis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 459
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
- •Key inclusion criteria:
- •Males or females at least 18 years of age at time of entry
- •Diagnosis of chronic plaque-type psoriasis for at least 6 months at time of randomization
- •At randomization, moderate to severe psoriasis (PASI = 12, IGA = 3, and BSA = 10%)
- •At screening and randomization, psoriasis considered inadequately controlled by topical treatment and / or phototherapy and / or previous systemic therapy
- •Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Key exclusion criteria:
- •Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization
- •Drug-induced psoriasis at randomization (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium)
- •Ongoing use of prohibited psoriasis treatments / medications (e.g., topical or systemic corticosteroids, UV therapy) at randomization
- •Ongoing use of other prohibited treatments at randomization. All concomitant medication must be on a stable dose for at least four weeks before first study drug administration.
- •Known immunosuppression (e.g., AIDS) at screening and / or randomization
- •History or evidence to suggest active TB at screening. All patients will be tested for TB status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent TB may enter the trial after sufficient treatment has been initiated according to local regulations.
- •Active systemic infections during the last two weeks before randomization (exception: common cold)
- •At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratoses, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
研究者
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