A Phase 3, Randomised, Investigator-blind, Active-controlled, Parallel Group, Multicentre Trial Comparing the Efficacy and Safety of 4-weeks Treatment With LEO 90100 and Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 604
- 试验地点
- 38
- 主要终点
- Percentage of Participants With Physician's Global Assessment of Disease Severity (PGA) Score of 0 (Clear) or 1 (Almost Clear) at Day 29, With at Least a 2-point Reduction From Baseline
研究概览
简要总结
This study is conducted to assess the efficacy and safety of LEO 90100 when used on the body for the treatment of stable plaque psoriasis in native adult Chinese subjects, compared to Daivobet® ointment.
详细描述
This study is phase 3, randomised, prospective, investigator-blinded, active-controlled, parallel group, multicentre trial to evaluate the efficacy and safety of 4 weeks treatment with LEO 90100 compared with Daivobet® ointment. Eligible participants will be randomised in a 1:1 ratio to either LEO 90100 or Daivobet® ointment treatment.
The trial will last for 6 weeks to 10 weeks for each participant, which includes wash out period and treatment period of up to 4 weeks and a safety follow up period of 2 weeks.
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
- Single (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
- •Chinese native
- •Aged 18 or over
- •A clinical diagnosis of stable plaque psoriasis for at least 6 months
- •Stable plaque psoriasis on the trunk and/or limbs (excluding psoriasis on the face, scalp, genitals, and skin folds) involving 2-30% of the body surface at Day 1 (Visit 2) of the trial.
- •Having a Physician Global Assessment of at least 'mild' at Day 1 (Visit 2)
- •An mPASI score of at least 2 on the trunk and/or limbs at Day 1 (Visit 2)
- •Women of childbearing potential must use an adequate form of birth control throughout the trial and for at least 8 weeks after last administration of IMP
- •Male subjects with a female partner of childbearing potential must use adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
- •Having a signed and dated informed consent.
排除标准
- •Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the specified time periods prior to treatment assignment (depending on treatment)
- •Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris within 4 weeks prior to treatment assignment
- •Psoralen combined with ultraviolet A therapy (PUVA) within 4 weeks prior to treatment assignment
- •Systemic treatment with Apremilast within 4 weeks prior to treatment assignment
- •Ultraviolet B (UVB) therapy within 2 weeks prior to treatment assignment
- •Topical treatment of psoriasis with strong corticosteroids within 2 weeks prior to treatment assignment
- •Topical treatment of psoriasis with traditional Chinese medicine within 2 weeks prior to treatment assignment
- •Treatment with any non-marketed drug substance (any agent which has not yet been made available for clinical use) within 4 weeks/5 half-lives prior to treatment assignment
- •Any other topical treatment that could affect plaque psoriasis within 2 weeks prior to treatment assignment
- •Current diagnosis of guttate, erythrodermic, exfoliative, pustular or unstable psoriasis
- •Patients with any of the following conditions present on any skin area: viral lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds
- •Disorders of calcium metabolism
- •Renal insufficiency, hepatic disorders or severe heart disease
- •Cushing's disease or Addison's disease
- •Known or suspected hypersensitivity to any component(s) of the investigational medicinal product (IMP)
- •Current participation in any other interventional clinical trial
- •Previously screened in this trial
- •Participation in another clinical trial within 4 weeks prior to treatment assignment
- •Women who are pregnant, wishing to become pregnant or are breast-feeding
- •Chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance
- •Employees of the trial site or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals
研究组 & 干预措施
Daivobet® ointment
The subjects will receive Daivobet® ointment once daily for 4 weeks.
干预措施: Daivobet® ointment (Drug)
LEO 90100
The subjects will receive LEO 90100 foam once daily for 4 weeks.
干预措施: LEO 90100 (Drug)
结局指标
主要结局
Percentage of Participants With Physician's Global Assessment of Disease Severity (PGA) Score of 0 (Clear) or 1 (Almost Clear) at Day 29, With at Least a 2-point Reduction From Baseline
时间窗: On Day 29
The efficacy of LEO 90100 compared with Daivobet® ointment on severity and extent of stable plaque psoriasis was evaluated. The PGA is an instrument used in clinical trials to rate the severity of psoriasis. It is a 5-point scale measurement ranging from 0 to 4, where 0- clear, 1- almost clear, 2- mild, 3- moderate and 4- severe; based on degree of plaque thickening, scaling and erythema. Higher score showed worse outcome.
次要结局
- Percentage of Participants With Decrease in Modified Psoriasis Area and Severity Index of at Least 75% (mPASI-75) From Baseline to Day 29(From Baseline to Day 29)
- Percentage of Participants With Decrease in mPASI of at Least 90% (mPASI-90) From Baseline to Day 29(From Baseline to Day 29)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(From Baseline to Day 43)