EUCTR2016-003718-28-DE进行中（未招募）1 期
A Randomized, Controlled, Multicenter, Open Label Study with Blinded Assessment of the Efficacy of the Humanized Anti-IL-23p19 Risankizumab Compared to FUMADERM® in Subjects with Moderate to Severe Plaque Psoriasis Who are Naïve to and Candidates for Systemic Therapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
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. Male or female subject = 18 and < 80 years of age at the time of screening.
- •2. Have a diagnosis of chronic plaque psoriasis for at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient.
- •3. Subject has stable moderate to severe plaque psoriasis with or without psoriatic arthritis at Baseline
- •Has an involved BSA > 10% and
- •Has a PASI score > 10 and
- •Has a DLQI > 10.
- •4. Must be naïve to and candidate for systemic therapy, as assessed by the investigator.
- •5. Subject has an inadequate response, intolerance or contraindication to topical psoriasis treatment as documented in the patient's medical history or reported by the patient or determined by the investigator at screening.
- •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 99
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •1. Subjects with
- •Non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
- •Drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- •Active ongoing inflammatory diseases other than psoriasis that might confound study evaluations according to investigator's judgment
- •2. Subject has previously received systemic therapy for psoriasis, whether biologic or non-biologic, or photochemotherapy (e.g. PUVA therapy, any UV-therapy or baneotherapy associated with UV-sensitizing agent. 3. Active systemic infections during the last 2 weeks (exception: common cold) prior to screening.
- •4. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
- •5. Subject has any condition or contraindication to FUMADERM® that would preclude the patient's participation in the present study, including, but not limited to:
- •A known hypersensitivity to fumaric acid derivatives or other components of FUMADERM® Initial or FUMADERM®,
- •Any parameter of the complete blood count (CBC) outside of normal range according to the central laboratory,
- •Severe liver disease (ALT or AST > 2 × ULN according to central laboratory normal range, or total bilirubin > 1.5 × ULN according to central laboratory normal range at Screening visit),
- •Severe kidney disease (serum creatinine above normal value according to central laboratory normal range at Screening visit),
- •Severe gastro-intestinal disease, such as a known active gastro-duodenal ulcer,
- •Inability to understand the complexity of FUMADERM® dosing regimen.
- •Any other exclusionary condition provided in Fumaderm® local label.
- •Any of the following risk factors for renal toxicity:
- •-peripheral vascular disease
- •-diabetes mellitus with microalbuminuria (UACR > 30 mg/g), at Screening visit
- •-systolic blood pressure measurement of > 140 mmHg or a diastolic blood pressure measurement of > 90 mmHg at the Screening Visit, unless there is confirmation from an Internist or a cardiologist that no renal or cardiovascular risk is associated with the elevated blood pressure.
- •-history of congestive heart failure (NYHA Class III or IV)
研究者
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