EUCTR2012-000035-82-DE进行中（未招募）1 期
A 2:1 randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Fumaderm® in young patients aged 10 to 17 years with moderate to severe psoriasis vulgaris (KIFUderm study). - KIFUderm study
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
- Biogen GmbH
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 informed consent (by patient and parents)
- •Male and female patients aged 10 to 17 years, using highly effective methods of birth control if they are sexually active or may become sexually active during the study. Highly effective methods of birth control result alone or in combination in a low failure rate (less than 1% per year); e.g. intrauterine devices or hormonal contraceptives, double barrier method.
- •Moderate to severe psoriasis vulgaris according rule of ten (PASI =10 or BSA = 10 or CDLQI/DLQI = 10) and the European consensus of treatment goals for moderate to severe psoriasis (i.e. special clinical situations may change mild psoriasis to moderate or to severe including involvement of e.g. visible areas of the head, genital areas or severe nail involvement) and history of psoriasis vulgaris for at least 6 months where previous, externally applied, stand-alone treatments have failed.
- •Need for systemic treatment: moderate to severe forms of psoriasis vulgaris in cases where previous, externally applied, stand-alone treatments have failed.
- •Weight > 30 kg
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 133
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Mild cases of psoriasis vulgaris, e.g. circumscribed plaque psoriasis or chronic stationary plaque psoriasis covering less than 10% of total body surface
- •Psoriasis pustulosa
- •Psoriasis arthritis
- •Values of lymphocytes and leukocytes below the normal range
- •Remaining differential blood count outside the normal range if judged as clinically significant
- •Platelet count outside the normal range if judged as clinically significant
- •Serum creatinine > upper limit of normal (ULN), reduced creatinine-clearance (calculated) (if the calculated creatinine-clearance is reduced with a normal serum creatinine, undertake a 12 h urine collection and re-test the creatinine clearance in this sample)
- •gamma-GT or GOT or GPT > 2-fold ULN
- •Proteinuria (+,++,+++)
- •Systemic therapy with Fumaderm® or Fumaderm® initial prior to the study
- •Systemic biologic therapy with:
- •o Etanercept within 3 months prior to study start (defined as date of signed ICF) or during the study
- •o Adalimumab, infliximab, or ustekinumab within 6 months prior to study start or during the study.
- •o Any prior therapy with efalizumab (Raptiva®)
- •Systemic corticosteroid therapy within 1 month prior to study start or during the study
- •Systemic therapy with methotrexate, ciclosporin or cytostatics within 1 month prior to study start or during the study
- •Phototherapy within 1 month prior to study start or during the study
- •Psoralens within 3 months prior to study start or during the study
- •Systemic therapy with acitretin or other retinoids within 3 months prior to study start or during the study
- •Drugs known to impair renal function 1 month prior to study start or during the study
- •Other Immunosuppressive medication (e.g. azathioprine) within 1 month prior to study start or during the study
- •Topical therapy with Vit. D3 analogues, dithranol, corticosteroids or any other topical treatment of psoriasis within 1 months prior to study start or during the study
- •Significant medical condition in particular gastrointestinal diseases (e.g. ulcus ventriculi and ulcus duodeni) which may affect patient safety and/or drug efficacy and/or study evaluation in the opinion of the investigator, particularly any immunosuppressive state.
- •Significant renal or liver disease
- •Any neoplasm in the patient’s history
- •Acute infections within the past 2 weeks prior to study start
- •Hypersensitivity to Fumaderm®, Fumaderm® initial, any of its ingredients used in Fumaderm® and Fumaderm® initial.
- •Hypersensitivity to Mannitol (replacement of active ingredients in placebo tablets)
- •Hypersensitivity to acrylates, adhesives, plasters, sulfones or desiccants.
- •Pregnant and/or breast-feeding female patients
- •Female patients of childbearing potential who are sexually active or who may become sexually active during the study and who do not agree to use one of the following effective methods of birth control for the duration of the study: Intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), practicing abstinence, double barrier method
- •Male patients who are sexually active or who may become sexually active during the study and who do not agree to use one of the following effective methods of birth control for the duration of the study: double barrier method, which means that the male patients use a condom and the female sexual partners use an effective
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