A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab, to Demonstrate Efficacy After Twelve Weeks of Treatment and to Assess Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis With or Without Psoriatic Arthritis Comorbidity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 543
- 试验地点
- 1
- 主要终点
- Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation)
研究概览
简要总结
The purpose of this study was to determine if secukinumab is effective and safe in the treatment of plaque type psoriasis
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
- •Subjects must give a written, signed and dated informed consent.
- •Men or women at least 18 years of age at time of screening.
- •Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline.
- •Moderate to severe psoriasis as defined at Baseline by:
- •PASI score of 12 or greater, and
- •IGA mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and
- •Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
- •Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by
- •topical treatment and/or,
- •phototherapy and/or,
- •previous systemic therapy.
排除标准
- •Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline.
- •Drug-induced psoriasis.
- •Ongoing use of prohibited treatments.
- •Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
- •Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
研究组 & 干预措施
Secukinumab 150mg
Secukinumab 150mg s.c.
干预措施: Secukinumab 150 mg s.c. (Drug)
Secukinumab 300mg
Secukinumab 300mg s.c.
干预措施: Secukinumab 300 mg s.c. (Drug)
Placebo
Placebo to secukinumab s.c
干预措施: Placebo (Drug)
结局指标
主要结局
Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation)
时间窗: Week 12
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation)
时间窗: Week 12
Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
次要结局
- Time to PASI 75 Response up to Week 12(week 12)
- Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation)(Week 52)
- Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation)(Week 12)
- Efficacy of Secukinumab in Maintaining IGA Mod 2011 0 or 1 Response at Week 52 in Subjects Who Were IGA Mod 2011 0 or 1 Responders at Week 12 (Multiple Imputation)(Week 52)
- PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)(week 1, week 12, week 24, week 52)
- American Collage of Rheumatology (ACR) Response 20/50/70(week 12, week 24, week 52)