An International, Multi-centre, Prospective, Randomised, Double-blind, 4-arm, Placebo Controlled, Parallel Group Study With 12 Weeks Once Daily Oral Treatment in Subjects With Psoriasis Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Percentage Change in Psoriasis Area and Severity Index (PASI)
研究概览
简要总结
An international, multi-centre, prospective, randomised, double-blind, 4-arm, placebo controlled, parallel group study with 12 weeks once daily oral treatment 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
- Double (Participant, 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
- •Following verbal and written information about the trial the subject must provide signed and dated informed consent before any study related activity is carried out, including activities relating to the washout period.
- •Clinical diagnosis of psoriasis vulgaris, for at least 6 months prior to randomisation, and currently covering at least 10% of the body surface area (BSA)
- •Candidates for systemic anti-psoriatic treatment
- •Psoriasis Area and Severity Index (PASI) ≥10
- •Disease severity of moderate, severe or very severe according to the Investigators' Global Assessment of disease severity (IGA)
- •Aged 18 years or above
- •Any race or ethnicity
- •Males, surgically sterile females (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or post menopausal females (at least 1 year since last menses)
- •Attending hospital outpatient clinic or the private practice of a dermatologist
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 - 4 weeks
- •Adalimumab, alefacept, infliximab - 2 months
- •Ustekinumab - 4 months
- •Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris (e.g.corticosteroids, retinoids, immunosuppressants, methotrexate, cyclosporin or fumaric acid) within 4 weeks prior to randomisation
- •PUVA therapy within 4 weeks prior to randomisation
- •UVB therapy within 2 weeks prior to randomisation
- •Any topical treatment (except for emollients/ medicated shampoo) within 2 weeks prior to randomisation
- •Initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g. beta-blockers, anti-malaria drugs, lithium) 2 weeks prior to randomisation and during the study
- •Current diagnosis with erythrodermic, exfoliative or pustular psoriasis
- •Other current skin conditions that may confound the evaluation of psoriasis vulgaris as judged by the Investigator
- •Generally in good health and does not have any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, haematologic, or gastrointestinal disease, immunologic insufficiency, or other major diseases or current condition which, in the opinion of the Investigator, would put the subject at risk by participating in the study
- •Current active tuberculosis or latent tuberculosis
- •Planned exposure to the sun during the study that may affect psoriasis vulgaris
- •Known malignancy or history of malignancy (other than cervical carcinoma in situ, basal cell or squamous cell carcinoma) within the 5 year period prior to randomisation
- •Live vaccination within the 4 weeks prior to randomisation
- •Males who do not agree to use adequate contraception during the study (including follow-up) to ensure their partner does not become pregnant
- •Known or suspected hypersensitivity to component(s) of the investigational product
- •Current participation in any other interventional trial
- •Treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks or 5 half-lives (whichever is longer) prior to randomisation
- •Previously randomised in this study
- •Known or, in the opinion of the Investigator, is unlikely to comply with the Clinical Study Protocol (e.g., alcohol abuse, drug dependency or psychotic state).
研究组 & 干预措施
LEO 22811 0.5 mg
LEO 22811 0.5 mg: Oral solution
干预措施: LEO 22811 (Drug)
LEO 22811 1.5 mg
LEO 22811 1.5 mg: Oral solution
干预措施: LEO 22811 (Drug)
LEO 22811 3.0 mg
LEO 22811 3.0 mg: Oral solution
干预措施: LEO 22811 (Drug)
Placebo
Placebo: Oral solution
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage Change in Psoriasis Area and Severity Index (PASI)
时间窗: Baseline (Day 0) to end of treatment (Day 84)
The investigator made assessments of the extent and severity of clinical signs of the participant's psoriasis on specific areas of the body in terms of three clinical signs: redness, thickness and scaliness. The extent of psoriatic involvement was recorded for each of four areas; head, arms, trunk and legs using the following scale: 0. = no involvement 1. = \<10% 2. = 10-29% 3. = 30-49% 4. = 50-69% 5. = 70-89% 6. = 90-100% For each clinical sign a single score (0, 1, 2, 3 or 4) reflecting the average severity of all psoriatic lesions on the given body region was determined. PASI was calculated based on the investigator's assessment of the disease locally (head, trunk, arm, legs) using the following formula: Head: 0.1 (R + T + S)E = W Arms: 0.2 (R + T + S)E = X Trunk: 0.3 (R + T + S)E = Y Legs: 0.4 (R + T + S)E = Z R = score for redness; T = score for thickness, S = score for scaliness; E = score for extent The sum of W+X+Y+Z gives the total PASI that ranges from 0 to 72.
次要结局
- Participants With at Least 75% Reduction in PASI (PASI 75)(From baseline (Day 0) to end of treatment (Day 84))
- Participants With at Least 50% Reduction in PASI (PASI 50)(From baseline (Day 0) to end of treatment (Day 84))
- Participants With "Controlled Disease" According to the Investigators' Global Assessment (IGA)(At end of treatment (Day 84))
- Participants With Satisfactory Response According to IGA(At end of treatment (Day 84))