Effectiveness and safety of Dimethylfumarate in patients with Palmoplantar Pustulosis – a 24-week, open label, phase II trial

Medical University of Vienna0 个研究点目标入组 25 人开始时间: 2017年11月3日最近更新: 2018年7月23日

适应症

试验速览

暂无简介。

•- Men or women = 18 years and = 80 years of age at time of screening
•- Palmoplantar pustulosis (PPP) for at least 6 months
•- moderate - severe disease as defined by a ppPASI score of = 10 for affection of palms and soles, =4 for palms only and =6 for feet only.
•- candidates for systemic treatment after failure of topical treatments
•- negative serum pregnancy before enrollment and during the study
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•- use of prohibited psoriasis treatments
•- pregant or nursing women
•- WBC count < 3,000 cells/ mm3, lymphocyte count < 1.000/µl
•- significant gastrointestinal problems (e.g., ulcer)
•- severe renal impairment (eGFR = 30ml/min)
•- abnormal liver enzymes
•- active infectious diseases
•- history of alcohol or intravenous drug abuse
•- Immunosuppressive conditions (HIV, organ transplant recipients)
•- Known to be hypersensitive to ingredients of the investigational products
•- Participation in any other drug investigational trial
•- Not willing to give informed consent
•- Unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study

发起方