A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Long-term Efficacy, Safety, and Tolerability up to 4 Years in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,147
- 试验地点
- 1
- 主要终点
- Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68
研究概览
简要总结
This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.
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
- 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
- •Completed the full study treatment period of 52 weeks in preceding phase III studies, and have been receiving secukinumab treatment during the maintenance phase of the preceding phase III studies, and show at least a partial response (PASI 50 or better) at Week 52 of the preceding phase III studies.
- •Written informed consent form.
排除标准
- •A protocol deviation in either of the preceding phase III studies which according to the investigator prevented the meaningful analysis of the extension study for the individual subject.
- •Ongoing use of prohibited psoriasis or non-psoriasis treatments.
- •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).
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
研究组 & 干预措施
PASI 75 Responders
PASI 75 responders participated in "randomized withdrawal". Subjects who were PASI 75 responders at Week 52 visit of the core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies were randomized to continue same s.c. doses of secukinumab in PFS or receive placebo every 4 weeks up to Week 152 or until relapse. Participants on first full relapse received loading dose followed by routine dosing with secukinumab s.c. 150 mg or 300 mg regimen.
干预措施: Secukinumab (AIN457) (Drug)
PASI 75 Responders
PASI 75 responders participated in "randomized withdrawal". Subjects who were PASI 75 responders at Week 52 visit of the core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies were randomized to continue same s.c. doses of secukinumab in PFS or receive placebo every 4 weeks up to Week 152 or until relapse. Participants on first full relapse received loading dose followed by routine dosing with secukinumab s.c. 150 mg or 300 mg regimen.
干预措施: Placebo (Drug)
Partial responders
Partial responders were not randomized. Subjects who were partial responders at Week 52 visit in core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies did not participate in the randomized withdrawal. These subjects continued same treatment s.c. dose in PFS (secukinumab s.c. 150 mg or 300 mg) as they were receiving at the time of completing the maintenance period (Week 52) in the core studies.
干预措施: Secukinumab (AIN457) (Drug)
结局指标
主要结局
Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68
时间窗: At week 68 (16 weeks after week 52)
The primary variable was the cumulative rate of patients who lost PASI 75 response up to Week 68 (time=0 being defined as Week 52). Loss of PASI 75 response was analyzed by means of a survival analysis defining "loss of PASI 75 response" as "failure". The term cumulative rate corresponded to 1 minus the survival function within this survival analysis, and the cumulative rate and the survival functions were dependent on time t. PASI 75 response: patients achieving ≥ 75% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 75 responders.
次要结局
- Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period(Week 68)
- Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period(Week 52, Week 104, Week 156, week 208, week 260)
- Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period(Week 52, Week 104, Week 156, week 208, week 260)
- Percent of Participants With Rebound After Last Injection(up to week 68)
- Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period(Week 52, Week 104, Week 156, week 208, week 260)
- Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period(Week 52, 104, and 156)
- Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period(Week 52, Week 104, Week 156, week 208, week 260)
- Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period(Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156)
- Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period(Week 52, 104, and 156)
- Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period(up to week 156)
- Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period(Week 52 (baseline), 104, and 156)
- Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse(up to week 260)
- Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse(up to week 260)
- Percent of Participants With Relapse After Last Injection(up to week 16)
- Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data)(Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156)
- Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period(Week 52 - 156)
- EQ-5D Health State Assessment (Observed Value) - Entire Study Period(week 64, 76, 88, 104, 116, 128, 140, and 156)
- Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period(Week 52-156)
- Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period(approximately 4 years)
- Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period(Approximately 4 years)
- EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period(Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156)