EUCTR2017-004998-13-NL进行中（未招募）1 期
Adjustable brodalumab dosage regimen compared with standard brodalumab treatment for 52 weeks in subjects with moderate-to-severe plaque psoriasis and =120 kg body weight
EO Pharma A/S0 个研究点目标入组 384 人开始时间: 2020年9月15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
- 384
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
- •Signed and dated informed consent has been obtained prior to any
- •protocol-related procedures.
- •- Age =18 to <75 years at the time of screening.
- •- Diagnosed with chronic plaque psoriasis at least 6 months before
- •randomisation.
- •- Body weight =120 kg at the time of screening.
- •- Moderate-to-severe plaque psoriasis as defined by: BSA =10% and
- •PASI =12 at screening and baseline.
- •- No current active tuberculosis.
- •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 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •- 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 the
- •investigational medicinal product (IMP) on subjects with plaque psoriasis
- •- Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations, or is immunocompromised (e.g., human immunodeficiency virus, hepatitis B, and hepatitis C).
- •- Any systemic disease considered by the investigator to be uncontrolled and either immunocompromising the subject and/or placing the subject at undue risk of intercurrent diseases (including, but not limited to, renal failure, heart failure, liver disease, diabetes, and anaemia).
- •- Known history of Crohn’s disease.
- •- Myocardial infarction or stroke, or unstable angina pectoris within the past 12 months.
- •- Any active malignancy.
- •- 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.
- •- 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 (C-SSRS) questionnaire at screening or at baseline.
- •- Any suicidal ideation of category 4 or 5 (‘active suicidal ideation with some intent to act, without specific plan’ or ‘ active suicidal ideation with specific plan and intent’) based on the C-SSRS questionnaire at screening or at baseline.
- •- A Patient Health Questionnaire (PHQ)-8 score of =10 corresponding to moderate-to-severe depression at screening or at baseline.
研究者
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