A Multicenter, Double-blind and Open Label, 4 Year Extension Study of Subcutaneous Secukinumab in Prefilled Syringes, Assessing Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Treated With Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 675
- 试验地点
- 1
- 主要终点
- Long-term Safety and Tolerability of Secukinumab
研究概览
简要总结
CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •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 consent according to local laws and regulations.
- •Subjects who complete Week 52 of study CAIN457A2304 or complete Week 40 of study CAIN457A2307
- •Subjects expected to benefit from participation in the extension study, as assessed by the subject and investigator
排除标准
- •A protocol deviation in the core studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject
- •Ongoing use of prohibited psoriasis or non-psoriasis treatments. Time period from last use of prohibited treatments in the core study to first dose of study drug in this extension study.
- •Subjects expected to be exposed to an undue safety risk if participating in the trial
- •Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial
- •Plans for administration of live vaccines during the study period
- •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 (>10 mIU/mL).
研究组 & 干预措施
AIN457 150 mg - Fixed Interval (FI)
1 s.c. Secukinumab 150 mg Pre-filled seringue (PFS) injection + 1 s.c. Placebo (PBO) Secukinumab PFS injection every 4 weeks
干预措施: AIN457 150 mg (Drug)
AIN457 150 mg - Fixed Interval (FI)
1 s.c. Secukinumab 150 mg Pre-filled seringue (PFS) injection + 1 s.c. Placebo (PBO) Secukinumab PFS injection every 4 weeks
干预措施: Placebo (Drug)
AIN457 150 mg - Start of relapse (SoR)
Start of relapse: 1 s.c. Secukinumab 150 mg PFS injection + 1 s.c. PBO Secukinumab PFS injection every 4 weeks
Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks
干预措施: AIN457 150 mg (Drug)
AIN457 150 mg - Start of relapse (SoR)
Start of relapse: 1 s.c. Secukinumab 150 mg PFS injection + 1 s.c. PBO Secukinumab PFS injection every 4 weeks
Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks
干预措施: Placebo (Drug)
AIN457 300 mg - Fixed Interval (FI)
2 s.c. Secukinumab 150 mg PFS injections every 4 weeks
干预措施: AIN457 300 mg (Drug)
AIN457 300 mg - Start of Relapse (SoR)
Start of relapse: 2 s.c. Secukinumab 150 mg PFS injection every 4 weeks
Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks
干预措施: AIN457 300 mg (Drug)
AIN457 300 mg - Start of Relapse (SoR)
Start of relapse: 2 s.c. Secukinumab 150 mg PFS injection every 4 weeks
Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks
干预措施: Placebo (Drug)
AIN457 300 mg - Open Label (OL)
Open Label - Secukinumab 300mg every 4 weeks
干预措施: AIN457 300 mg (Drug)
结局指标
主要结局
Long-term Safety and Tolerability of Secukinumab
时间窗: Week 268
Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)
次要结局
- Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260(Week 52, Week 104, Week 156, Week 208, Week 260)
- Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260(Week 52, Week 104, Week 156, Week 208, Week 260)
- Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260(Baseline, Week 52, Week 104, Week 156, Week 208, Week 260)
- Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260(Week 52, Week 104, Week 156, Week 208, Week 260)
- Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260(Baseline, Week 52, Week 104, Week 156, Week 208, Week 260)
- Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260(Week 52, Week 104, Week 156, Week 208, Week 260)
- EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D©) Score and Percent Change From Baseline at Weeks 52, 104 and 156(Baseline, Week 52, Week 104, Week 156)
- Number of Participants With Treatment Emergent Anti-drug Antibodies (ADA)(Week 268)
- Percentage of Patients With Experiencing a Relapse(Week 260)
- Percentage of Patients With Experiencing a Rebound(Up to Week 264 (8 weeks post last dose))