Pharmacokinetic Evaluations of Ixekizumab Following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector in Patients With Moderate-to-Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device
研究概览
简要总结
The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.
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
- None
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
- •Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization
- •At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
- •Static Physician Global Assessment (sPGA) score of at least 3 AND Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at randomization
- •Candidate for phototherapy and/or systemic therapy
- •Men must agree to use a reliable method of birth control during the study
- •Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
排除标准
- •Pustular, erythrodermic, and/or guttate forms of psoriasis
- •History of drug-induced psoriasis
- •Clinically significant flare of psoriasis during the 12 weeks prior to randomization
- •Concurrent or recent use of any biologic agent
- •Received systemic psoriasis therapy [such as psoralen and ultraviolet A (PUVA) light therapy] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
- •Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
- •Have participated in any study with interleukin-17 (IL-17) antagonists, including Ixekizumab
- •Serious disorder or illness other than plaque psoriasis
- •Serious infection within the last 3 months
- •Breastfeeding or nursing (lactating) women
研究组 & 干预措施
80 mg Ixekizumab Auto-Injector
Ixekizumab administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection every 2 weeks (Q2W) at week 2, 4, 6, 8 and 10. Starting from Week 12, 80 mg Ixekizumab Prefilled Syringe was administered by one 80 mg SC injection every 4 weeks (Q4W).
干预措施: Ixekizumab Auto-Injector (Drug)
80 mg Ixekizumab Prefilled Syringe
Ixekizumab administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10. Starting from Week 12, 80 mg Ixekizumab Prefilled Syringe was administered by one 80 mg SC injection Q4W.
干预措施: Ixekizumab Prefilled Syringe (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device
时间窗: Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
Cmax by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0.
PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device
时间窗: Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
AUC 0-tlast by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.
次要结局
- PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen)(Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))
- PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen)(Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))
- PK: Cmax by Body Weight(Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))
- PK: AUC 0-tlast by Body Weight(Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))
- Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI)(Week 12)
- Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment (sPGA)(Week 12)
- Percentage of Participants With a Static Physician Global Assessment (sPGA) (0)(Week 12)
- Percentage of Device Operation Failures(Baseline through Week 12)
- Percentage of Participants With Anti-Ixekizumab Antibodies(Baseline to Week 12)
- SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)(Baseline, Week 4 and Week 8)