A Multicenter, Randomized, Double-blind, Placebo-controlled, 52-weeks Study to Demonstrate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab Injections With 2 mL Pre-filled Syringes (300 mg) in Adult Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment
研究概览
简要总结
The aim of the study was to demonstrate efficacy, safety and tolerability of 2 mL pre-filled syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.
详细描述
This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in 24 subjects with moderate to severe 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 eligible for inclusion in this study must fulfill all of the following criteria:
- •Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
- •Men or women of at least 18 years of age at the time of Screening.
- •Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization.
- •Moderate to severe psoriasis as defined at Randomization by:
- •PASI score of 12 or greater, and
- •IGA mod 2011 score of 3 or greater (based on a 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 Randomization.
- •Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited.
- •Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited.
- •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.
- •History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
- •History of hypersensitivity to any of study drug constituent
研究组 & 干预措施
Placebo
Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe
干预措施: Placebo (Drug)
Secukinumab 2 mL form
Secukinumab 300 mg, provided in a 2 mL pre-filled syringe
干预措施: Secukinumab 2 mL form (Drug)
Secukinumab 1 mL form
Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)
干预措施: Secukinumab 1 mL form (Drug)
结局指标
主要结局
Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment
时间窗: 12 weeks
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. Number of participants who achieved IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline
Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment
时间窗: 12 weeks
Number of participants who achieved ≥ 75% reduction in PASI compared to baseline 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).
次要结局
- Participants With PASI 90 After 12 Weeks of Treatment(12 weeks)
- Number of Participants With PASI 100 Response After 12 Weeks of Treatment(12 weeks)
- Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response(up to week 52)