NCT01866163已完成3 期
LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 426
- 试验地点
- 1
- 主要终点
- Treatment Success According to IGA
研究概览
简要总结
The purpose of this trial is to compare the efficacy of treatment with LEO 90100 to that of treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.
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
- •A clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving the trunk and/or limbs
- •Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the Body Surface Area (BSA)
- •An Investigator's Global Assessment of disease severity (IGA) of at least mild at Day 0 (Visit 1)
- •A modified PASI (m-PASI) score of at least 2 at Day 0 (Visit 1)
- •A target lesion of a minimum of 5 cm at its longest axis and preferably not located on the extensor surface on an elbow or knee, scoring at least 1 for each of redness, thickness and scaliness, and at least 4 in total by the Investigator's Assessment of Severity of the Target Lesion
排除标准
- •Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
- •etanercept - within 4 weeks prior to randomisation
- •adalimumab, infliximab - within 8 weeks prior to randomisation
- •ustekinumab - within 16 weeks prior to randomisation
- •other products - within 4 weeks/5 half-lives prior to randomisation (whichever is longer)
- •Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants) within 4 weeks prior to randomisation.
- •Subjects who have received treatment with any nonmarketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
- •PUVA therapy within 4 weeks prior to randomisation.
- •UVB therapy within 2 weeks prior to randomisation.
- •Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within 2 weeks prior to randomisation.
- •Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation.
- •Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors) during the trial.
- •Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
- •Previously randomised in this trial or any previously conducted trial of LEO 90100.
研究组 & 干预措施
LEO 90100
Experimental
LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
干预措施: LEO 90100 (Drug)
Vehicle
Placebo Comparator
Aerosol foam vehicle
干预措施: Vehicle (Drug)
结局指标
主要结局
Treatment Success According to IGA
时间窗: 4 weeks
Subjects with 'treatment success' ('clear' or 'almost clear' for subjects with at least moderate disease at baseline, 'clear' for subjects with mild disease at baseline) according to the Investigators' global assessment of disease severity (IGA) at Week 4. The 5 point IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate and 5 = severe
次要结局
- m-PASI at Week 1(1 week)
- m-PASI at Week 4(4 weeks)
研究者
研究点 (1)
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