Multicenter, rAndomized, Double-blind, Placebo-conTrolled, 52-week stUdy to demonstRatE the Efficacy, Safety and Tolerability of Secukinumab Injections With 2 mL Auto-injectors (300 mg) in Adult Subjects With Plaque Psoriasis
概览
- 阶段
- 3 期
- 干预措施
- Placebo 2 mL auto-injector
- 疾病 / 适应症
- Plaque Psoriasis
- 发起方
- Novartis Pharmaceuticals
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- PASI 75 Response After 12 Weeks of Treatment
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
The primary purpose of this study is to assess efficacy, safety and tolerability of a 2 mL pre-filled auto-injector (AI) of 300 mg secukinumab in patients with moderate to severe plaque psoriasis
详细描述
This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in approximately 120 subjects with moderate to severe plaque-type psoriasis
研究者
入排标准
入选标准
- •Subjects eligible for inclusion in this study must have fulfilled all of the following criteria:
- •Men or Women of at least 18 years of age at time of Screening
- •Subjects able to understand and communicate with the investigator and comply with the requirements of the study and must have given a written, signed and dated informed consent before any study related activity was performed. Where relevant, a legal representative signed the informed study consent according to local laws and regulations.
- •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
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 had 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 were considered not eligible for this study since UV light exposure was prohibited.
- •Note: administration of live vaccines 6 weeks prior to Randomization or during the study period was 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 had returned to baseline, whichever is longer; or longer if required by local regulations.
- •Pregnant or nursing (lactating) women, where pregnancy was 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 was evidence of local recurrence or metastases (except for Bowen's disease, or basal cell carcinoma or actinic keratoses that had 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 2 mL auto-injector
Placebo to secukinumab s.c., provided in 2 mL auto-injector form
干预措施: Placebo 2 mL auto-injector
Placebo 1 mL prefilled syringe
Placebo to secukinumab s.c., provided in 2 \* 1 ml prefilled syringe form
干预措施: Placebo 1 mL prefilled syringe
Secukinumab 2 mL auto-injector
Secukinumab 300 mg provided in 2 mL auto-injector form
干预措施: Secukinumab 2 mL auto-injector
Secukinumab 1 mL prefilled syringe
Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL
干预措施: Secukinumab 1 mL prefilled syringe
结局指标
主要结局
PASI 75 Response After 12 Weeks of Treatment
时间窗: 12 weeks
Percentage of participants who achieve ≥ 75% reduction in PASI compared to baseline. A PASI (Psoriasis Area and Severity Index) score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).
IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment
时间窗: 12 weeks
Percentage of participants who achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline. This scale ranges from 0 (clear, no signs of psoriasis) to 4 (severe).
次要结局
- PASI 90 Response(12 weeks)
- PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response(52 weeks)
- Successful Self-injection(From randomization until Week 28)
- Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score)(Change from Baseline up to 52 weeks)