Efficacy of Roflumilast in the Treatment of Psoriasis - a Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- PASI75
研究概览
简要总结
Roflumilast (Daxas®), a selective, long-acting inhibitor of the enzyme phosphodiesterase-4 (PDE4), is used for severe chronic obstructive pulmonary disease. Recent research suggest roflumilast is effective in treating psoriasis. The aim of this investigator-initiated trial is to study the efficacy of oral roflumilast in patients with plaque psoriasis. This has not previously been done.
详细描述
Aim: To investigate the efficacy of roflumilast in the treatment of psoriasis.
Design: Multicentre, double-blinded, randomised, placebo-controlled, clinical trial.
Participants: Patients ≥18 years with plaque psoriasis.
Method: Twelve weeks treatment with either roflumilast or placebo tablets. Both groups continue for an additional 12 weeks open-label treatment.
Primary endpoint: Proportion of patients achieving at least 75% reduction from baseline psoriasis area and severity index (PASI75) at week 12.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Chronic stable plaque psoriasis (min duration 6 months)
- •Body mass index (BMI) > 20 kg/m2
- •Candidate for systemic treatment of psoriasis
- •Negative pregnancy test (only women)
- •Safe anticonception during entire study and at least 1 week after end of treatment (~5 times plasma half-life of roflumilast) (only applying for fertile women)
排除标准
- •Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis
- •Current tuberculosis
- •Current viral hepatitis
- •Heart failure (NYHA III-IV)
- •Moderate or severe liver failure (Child-Pugh B-C)
- •Current or former malignancy (basal cell carcinoma excluded)
- •Current or former depression with suicidal ideation
- •Topical therapy for psoriasis during within 2 of randomization or during study
- •Systemic therapy for psoriasis or psoriatic arthritis within 4 weeks of randomization or during study
- •Treatment with theophylline, phenobarbital, carbamazepine, or phenytoin
- •Confirmed pregnancy
- •Planned pregnancy within 6 months
- •Breast feeding
- •Blood donation during study
- •Inability to complete study
研究组 & 干预措施
Roflumilast
Roflumilast 500 microgram daily (capsule)
干预措施: Roflumilast (Drug)
Placebo
Placebo (capsule)
干预措施: Roflumilast (Drug)
结局指标
主要结局
PASI75
时间窗: 12 weeks
Proportion of patients achieving at least 75% reduction from baseline psoriasis area and severity index (PASI75) at week 12. PASI is a measure of psoriatic disease severity.
次要结局
未报告次要终点
研究者
Mette Gyldenløve
MD, PhD
Bispebjerg Hospital