A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of Once Daily Oral ZPL-3893787- 18 (30 mg) Administered for 12 Weeks in Adult Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 4
- 主要终点
- Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12
研究概览
简要总结
This was a randomized, double blind, placebo controlled, parallel group study in 129 subjects with moderate to severe psoriasis with a PASI score of at least 10. Following run-in, subjects were randomized and received either oral 30 mg ZPL-3893787 once daily or placebo once daily for 12 weeks.
详细描述
This was a randomized, double blind, placebo controlled, parallel group study in 129 subjects with moderate to severe psoriasis with a Psoriasis Area and Severity Index (PASI) score of at least 10 and an Investigator's Global Assessment (IGA) of 3 (0-4 scale). Following run-in subjects received either oral 30 mg ZPL-3893787 once daily or placebo once daily for 12 weeks. Subjects attended the clinic at Baseline (Day 0) when they were reviewed and confirmed they met inclusion/exclusion criteria. Subjects were then randomized and received either oral 30 mg ZPL-3893787 once daily or placebo once daily for 12 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
- 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 documented history of moderate to severe plaque psoriasis for at least 6 months prior to screening.
- •Male or female, aged ≥18 years.
- •Psoriasis Area and Severity Index (PASI) ≥10 at both Screening and Day
- •An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day
- •Psoriasis affecting ≥10% body surface area (BSA) at Screening and Day 0.
排除标准
- •Current diagnosis of Pustular, Guttate, Erythrodermic, exfoliative or only nail psoriasis or a diagnosis of inverse psoriasis without having plaque psoriasis.
- •Concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation or presence of skin comorbidities that may interfere with study assessments.
- •Active skin infections (e.g. impetigo, abscesses) or any other clinically apparent infections.
- •Biologic treatments for psoriasis (e.g. Enbrel, Humira, Stelara, Cosentyx) within 3 months of the start of the Run-In.
- •Phototherapy (e.g. UVA, UVB, PUVA) within 4 weeks of the start of the Run-In.
- •Oral calcineurin inhibitors and immunosuppressants (e.g. cyclosporine, azathioprine, methotrexate) within 4 weeks of the start of the Run-In.
- •Systemic corticosteroids within 4 weeks of the start of the Run-In.
- •Oral antihistamines and leukotriene inhibitors and tricyclic antidepressants within 1 week of the start of the Run-In.
- •Topical steroids (any potency), topical calcineurin inhibitors (tacrolimus, pimecrolimus), salicylic acid and urea containing treatments and coaltar preparations, topical and oral retinoids and vitamin D derivatives, within 1 week of the start of the Run-In.
研究组 & 干预措施
ZPL-389
Each subject was given 30 mg ZPL-3893787 capsules, to be taken orally once daily (OD) for 12 weeks.
干预措施: ZPL-3893787 (Drug)
Placebo
Each subject was given 30 mg capsules of matching placebo, to be taken orally OD for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12
时间窗: From baseline to week 12
The PASI is an assessment routinely used for evaluating and grading the severity of psoriatic lesions and their response to therapy. PASI divides the body into 4 regions: the head, trunk, upper extremities (arms) and lower extremities (legs). Each of these areas is assessed separately for erythema, in duration and scaling; these symptoms are scored on a 5-point scale from 0-4, where 0 = no symptoms and 4 =very marked. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents a reduction of at least 75% from baseline in the PASI score.
次要结局
- Improvement in Investigator Global Assessment (IGA) at Week 12(From baseline to week 12)
- Change From Baseline in Body Surface Area (BSA) and Percentage Change From Baseline at Week 12(From baseline to week 12)
- Change From Baseline in the Daytime and Night Time NRS for Pruritus (Worst Itch) at Week 12(From baseline to week 12)
- Change From Baseline in the NRS for Sleep Disturbance at Week 12(From baseline to week 12)
- Number of Participants for Each Verbal Rating Scale (VRS) Score for Pruritus at Week 12(From baseline to week 12)
- PASI-50 and PASI-75 Responders at Week 12(From baseline to week 12)
- Patient Global Impression of Change (PGIC) a Week 12(From baseline to week 12)
- Change From Baseline in Total, Daytime and Night Time Duration of Itching at Week 12(From baseline to week 12)
- Change From Baseline in the Numerical Rating Scale (NRS) for Pruritus (Worst Itch) at Week 12(From baseline to week 12)