NL-OMON56463尚未招募4 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; ADJUST - ADJUST
eo Pharma0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6
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
- 年龄范围
- 18 至 99（—）
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 as determined by the investigator.
- •* 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 evidence of active or latent tuberculosis according to local standard of
- •care for patients requiring initiation of a biologic treatment
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 theinvestigational
- •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
- •* 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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