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
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving a 75% reduction in their Psoriasis Area and Severity Index (PASI75) score from baseline
研究概览
简要总结
This multicenter, randomised, double-dummy, Fumaderm® and placebo-controlled, parallel-group study will compare the efficacy and safety of 500 mg of FP187 (250 mg twice daily) compared to 720 mg Fumaderm® (240 mg three times daily) over 20 weeks of treatment. After an initial wash-out non-drug treatment phase of 1 to 6 weeks, all patients will receive allocated Study treatment up-titrated to the relevant dose level (i.e., 500 mg daily FP187, 720 mg daily Fumaderm®, or placebo). The up-titration to full dose will last 4 weeks for FP187 and 9 weeks for Fumaderm®. After 20 weeks of treatment, all patients will be asked to enter a separate open label treatment protocol expected to continue for up to 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >=18 years of age;
- •clinical diagnosis of stable moderate to severe plaque psoriasis for at least 6 months;
- •clinical diagnosis of plaque psoriasis with an affected body surface area of no less than 10% and least 10 on the PASI scale and on the sPGA score at least as moderate;
- •Besides psoriasis, patient is in good general health
- •Patients with a DLQI score of at least 10
排除标准
- •Pustular forms of psoriasis, erythrodermic or guttate psoriasis;
- •Known immunosuppressive diseases;
- •Presence of another serious or progressive disease including skin malignancies;
- •Active skin disease;
- •Use of topical medical treatment or UVB treatment during the 2 weeks preceding randomization;
- •Use of systemic anti-psoriatic treatment preceding randomization: methotrexate, cyclosporine, steroids or PUVA (psoralen + UVA treatment) treatment within 4 weeks; biological treatment within 12 weeks; Stelara within 20 weeks; acitretin within 6 months;
- •Treatment with Fumaderm® or other Dimethyl Fumarate containing products within 12 weeks prior randomization;
- •Treatment with drugs influencing the course of psoriasis (e.g., antimalarial drugs, lithium) within 4 weeks prior to randomization;
- •Treatment with retinoids, other immunosuppressive treatment, cytostatics or drugs with known harmful effects on the kidneys within 3 months prior to randomization;
- •On-going stomach or intestinal problems;
- •Aspartate transaminase (AST), Alanine transaminase (ALT) > 2 x upper normal limit (ULN), or Gamma-glutamyltransferase (γ-GT) > 2.5 x ULN;
- •Creatinine Clearance < 60 ml/min;
- •Leucopenia, eosinophilia or lymphopenia;
- •Protein in the urine test;
研究组 & 干预措施
Dimethyl fumarate
720 mg Fumaderm® daily (240 mg three times daily)
干预措施: Dimethyl fumarate (Drug)
FP187
500 mg FP187 daily (250 mg twice daily)
干预措施: FP187 (Drug)
FP187
500 mg FP187 daily (250 mg twice daily)
干预措施: Fumaderm® placebo (Drug)
Dimethyl fumarate
720 mg Fumaderm® daily (240 mg three times daily)
干预措施: FP187 placebo (Drug)
Placebo
Matching FP187 and Fumaderm® placebo
干预措施: FP187 placebo (Drug)
Placebo
Matching FP187 and Fumaderm® placebo
干预措施: Fumaderm® placebo (Drug)
结局指标
主要结局
Proportion of patients achieving a 75% reduction in their Psoriasis Area and Severity Index (PASI75) score from baseline
时间窗: after 20 weeks of treatment
Responder rate of Static Physician's Global Assessment (sPGA)
时间窗: after 20 weeks of treatment
Achieving a score of clear or almost clear or a 2 step improvement on a 6-point scale as compared to baseline.
次要结局
未报告次要终点