EUCTR2019-004099-20-CZ进行中（未招募）1 期
Efficacy and safety comparison of brodalumab versus guselkumab in adultsubjects with moderate-to-severe plaque psoriasis and inadequate response to ustekinumab.
EO Pharma A/S0 个研究点目标入组 260 人开始时间: 2020年10月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
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
- •- Subject is =18 years of age at the time of screening.
- •- Subject has a diagnosis of plaque psoriasis for at least 6 months before the first administration of investigational medicinal product (IMP) as determined by the investigator.
- •- Subject has inadequately controlled plaque psoriasis currently treated with ustekinumab, and fulfil ALL of the following criteria:
- •- Ustekinumab administered at least 3 times at or higher than the
- •approved dose or frequency for at least 24 weeks.
- •- IGA =2 at screening and baseline.
- •- Absolute PASI >3 at screening and baseline.
- •- The last administration of ustekinumab was =12 weeks before randomisation.
- •- Subject has no active tuberculosis at screening (negative QuantiFERON® or purified protein derivative [PPD] test). Subjects
- •with adequately treated latent tuberculosis are eligible.
- •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 260
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 260
排除标准
- •- Subject was diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g. eczema) that would interfere with evaluations of the effect of IMP on plaque psoriasis.
- •- Subject has clinically important active infections or infestations, chronic, recurrent, or latent infections or infestations, or is immunocompromised (e.g. human immunodeficiency virus).
- •- Subject has any systemic disease (e.g. renal failure, heart failure, hypertension, liver disease, diabetes, anaemia) considered by the investigator to be clinically significant and uncontrolled.
- •- Subject has a known history of Crohn’s disease.
- •- Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
- •- Subject has a history of malignancy within 5 years, except for treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma.
- •- Subject has a known history of active tuberculosis.
- •- Subject has a history of suicidal behaviour (i.e. ‘actual suicide attempt’, ‘interrupted attempt’, ‘aborted attempt’, or ‘preparatory acts or behaviour’) based on the Columbia-Suicide Severity Rating Scale (CSSRS) questionnaire at screening or baseline.
- •- Subject has any suicidal ideation of severity 4 or 5 (‘some intent to act, no plan’ or ‘specific plan and intent’) based on the C-SSRS questionnaire at screening or baseline.
- •- Subject has a Patient Health Questionnaire-8 (PHQ-8) score of =10, corresponding to moderate-to-severe depression at screening or baseline.
- •- Subject has previously received more than 1 tumour necrosis factor-a (TNF-a) inhibitor.
- •- Subject has previously been treated with any anti-interleukin (IL)-17A, anti-IL-17 receptor subunit A, or anti-IL-23 besides ustekinumab.
- •- Subject has known or suspected hypersensitivity to any component(s) of the IMPs.
研究者
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