Investigation of Flare and Remission in Atopic Dermatitis in an Integrated Longitudinal Trial: Effects of Systemic Treatment With Cyclosporine A
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- LEO Pharma
- 试验地点
- 1
- 主要终点
- Time to flare* in subjects with moderate-to-severe AD who responded to a 3-week course of high-dose CsA treatment.
研究概览
简要总结
The trial is an exploratory, single-centre, uncontrolled, open-label, interventional trial of up to 19 weeks' duration to investigate flare and remission in subjects with moderate-to-severe atopic dermatitis (AD) treated with cyclosporine A (CsA).
详细描述
40 subjects with moderate-to-severe AD will be treated with a 3-week course of high-dose CsA, which is a standard-of-care treatment regimen. After 3 weeks, all responders shift to oral low-dose CsA treatment (2-2.5 mg/kg/day) until onset of a second flare or until Week 16 (Day 113).
In case of a second AD flare, the subjects shift back to oral high-dose CsA treatment (4-5 mg/kg/day) for 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Diagnosis and history of chronic, moderate-to-severe AD (by the Eichenfield revised criteria of Hanifin and Rajka) for at least 3 years before the screening visit.
- •Subjects who have an AD flare at the start of the trial (EASI score ≥10 at screening and ≥16 at the baseline visit).
排除标准
- •Treatment with allergen immunotherapy within 6 months before the baseline visit.
- •Treatment with leukotriene inhibitors, systemic glucocorticoids, or other systemic treatment for AD (including immunosuppressive treatment, ultraviolet therapy, and biologics) within 4 weeks before the baseline visit.
- •Treatment with topical corticosteroids or topical calcineurin inhibitors within 1 week before the baseline visit.
- •Chronic or acute infection requiring treatment with oral or intravenous antibiotics, anti-virals, anti-parasitics, anti-protozoals, or anti-fungals within 4 weeks before the screening visit or superficial skin infections within 1 week before the screening visit.
- •History of malignancy within 5 years before the baseline visit, with the following exceptions: subjects with a history of completely treated carcinoma in situ of cervix, and non-metastatic squamous or basal cell carcinoma of the skin are allowed.
- •Hypertension (>150/95 mmHg) at the screening visit.
- •Planned surgical procedure during the length of the subject's participation in this trial.
- •Use of a tanning booth/parlour within 4 weeks before the screening visit.
- •Pregnant, breastfeeding, or lactating women.
- •Laboratory abnormalities at the screening visit.
研究组 & 干预措施
Cyclosporine A treatment
Oral cyclosporine A treatment
干预措施: Cyclosporine A (Drug)
结局指标
主要结局
Time to flare* in subjects with moderate-to-severe AD who responded to a 3-week course of high-dose CsA treatment.
时间窗: Day 1 to Day 113 (end of trial)
\*A flare is defined as exacerbation of the disease, where intensification of medicine is considered necessary.
次要结局
- Number of subjects with TEAEs up until end of trial.(Up to Day 113 (end of trial))
- Number of treatment-emergent adverse events (TEAEs) up until end of trial.(Up to Day 113 (end of trial))