EUCTR2012-005685-35-DE进行中（未招募）1 期
A randomised, double blind, double dummy, active comparator and placebo controlled confirmative non-inferiority trial of FP187 compared to Fumaderm in moderate to severe plaque psoriasis
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
- 800
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
- •? Patients of either sex at least 18 years of age
- •? Patients with a clinical diagnosis of stable moderate to severe plaque psoriasis (PASI value above 10) for at least 6 months prior to trial start will be eligible for randomization for the trial.
- •? Patients with a clinical diagnosis of plaque psoriasis defined as skin areas with erythema, induration and scaling, with an affected body surface area (BSA)>10% and in total to be scoring > 10 on the PASI scale and on the sPGA score at least as moderate (=3 at the 6-point scale), defined as:
- •-Systemic treatment naive patients who cannot be controlled in their disease symptoms with a topical treatment and are candidates for systemic treatment; or
- •- Patients who have failed under treatment with other first or second line systemic treatments.
- •? Signed and dated informed consent,
- •? Females of childbearing potential must be either surgically sterile (hysterectomy or tubal ligation) or use a highly effective (failure rate <1%) medically accepted contraceptive method during the trial as well as one month after trial is finished such as:
- •– Systemic contraceptive (oral, implant, injection),
- •– Intrauterine device (IUD) inserted for at least one month prior to trial entrance
- •? Willingness and ability to comply with the trial procedures.
- •? Besides psoriasis, patient is in good general health in the opinion of the Investigator, as determined by medical history, physical examination, vital signs (systolic and diastolic blood pressure [upper limit 160/95] pulse rate [between 50 and 100]), electrocardiogram (ECG), and clinical laboratory parameters (haematology, biochemistry and urinalysis)). Minor deviations of laboratory values from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.
- •? Patients have to have a DLQI>10
- •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 744
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 56
排除标准
- •? Female patients who are pregnant or breast-feeding or planning to become pregnant during the entire trial period as well as male patients planning pregnancy with their partner during the entire trial period or practice unprotected sexual relationship during the entire trial period.
- •? Male patients planning pregnancy with their partner during the entire trial period, or practicing unprotected sexual relationship during the entire trial period.
- •? Known allergy to any of the constituents of the products being tested,
- •? Pustular forms of psoriasis, erythrodermic or guttate psoriasis,
- •? Known immunosuppressive diseases (e.g., AIDS/HIV),
- •? Presence of another serious or progressive disease including skin malignancies, which, according to the Investigator may interfere with treatment outcome,
- •? Active skin disease such as atopic dermatitis, rosacea, lupus erythematous, or other inflammatory or infectious skin disease which, according to the Investigator may interfere with treatment outcome,
- •? Use of topical medical treatment or UVB treatment during the 2 weeks preceding Visit 3
- •? Use of systemic anti-psoriatic treatment preceding Visit 3:
- •– Methotrexate, cyclosporine, steroids or PUVA treatment within 4 weeks,
- •– Biological treatment (efalizumab, adalimumab, infliximab, etanercept) within 12 weeks, or Stelara within 20 weeks
- •– Acitretin within 6 months,
- •-– Not named drugs should have a wash-out of 5 times their half-life
- •? Treatment with Fumaderm® or other DMF containing products during the past 12 weeks prior to Visit 3,
- •? Has within the past 4 weeks prior to Visit 3 been treated with drugs influencing the course of the psoriasis such as antimalarial drugs, or lithium,
- •? Treatment with retinoids, other immunosuppressive treatment, cytostatics or drugs with known harmful effects on the kidneys within the last 3 month, also if currently kidney functions are normal.
- •? Has on-going stomach or intestinal problems (e.g. gastritis or peptic ulcer),
- •? Has liver enzyme results (AST, ALT,) > 2 x upper normal limit (ULN) or gamma-GT results > 2.5 x ULN
- •? Has an estimated Creatinine Clearance (Cockcroft-Gault): < 60 ml/min,
- •? Has leucopenia (leukocyte count < 3.5x109/l) or eosinophilia (count > 750/µl) or lymphocytopenia (count < 1.02 x109/l),
- •? Has protein in the urine stick test at Visit 1 and at Visit 2, and confirmed in a subsequent complete urine analysis
- •? Participation in another clinical trial during the last two months preceding Visit 3 or participation in a trial with treatment with biologicals within 6 months prior to Visit 3,
- •? Patients who are involved in the organisation of the clinical investigation or are in any way dependent on the Investigator or sponsor
- •? Patients in whom Fumaderm® is contraindicated.
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