LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 722
- 试验地点
- 58
- 主要终点
- Time to First Relapse
研究概览
简要总结
A phase 3 trial comparing the efficacy and safety of LEO 90100 aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance therapy in subjects with psoriasis vulgaris.
A 12-month, international, multi-centre, randomised, vehicle controlled, double-blind, 2-arm, parallel group trial.
详细描述
After an initial 4-week period of once-daily treatment with open-label active LEO 90100 aerosol foam, subjects who qualify for randomisation will continue into a 52-week maintenance treatment period with twice-weekly application of randomised LEO 90100 aerosol foam / LEO 90100 aerosol foam vehicle.
If the subject experiences a relapse of psoriasis, the active lesions will be treated for 4 weeks with open-label active LEO 90100 aerosol foam.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LEO 90100 aerosol foam
Topical application twice weekly for 52 weeks
干预措施: LEO 90100 aerosol foam (Drug)
LEO 90100 aerosol foam vehicle
Topical application twice weekly for 52 weeks
干预措施: LEO 90100 aerosol foam vehicle (Drug)
结局指标
主要结局
Time to First Relapse
时间窗: From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)
Time to first relapse (at least 'mild' according to the Physician's Global Assessment of disease severity \[PGA\]). The investigator was to grade the severity of psoriasis of the trunk and limbs using Physician's global assessment of disease severity 5-point scale: Clear = 0; Almost clear = 1; Mild = 2; Moderate = 3; Severe = 4
次要结局
- Proportion of Days in Remission During the Maintenance Phase(From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal))
- Number of Relapses During the Maintenance Phase(From Randomisation (Week 4) until End of Treatment (Week 56))