A 24-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Guselkumab in Patients With Moderate-to-Severe Plaque Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,027
- 试验地点
- 120
- 主要终点
- Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100)
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque 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
- 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
- •Have chronic plaque psoriasis based on a diagnosis for at least 6 months before baseline as determined by the investigator.
- •Are a candidate for phototherapy and/or systemic therapy.
- •Have both an Static Physician Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (PASI) score ≥12 at screening and at baseline.
- •Have ≥10% body surface area (BSA) involvement at screening and baseline.
- •If a male, agree to use a reliable method of birth control during the study.
- •If female, agree to use highly effective method of contraception.
排除标准
- •Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis.
- •Have a history of drug-induced psoriasis.
- •Had a clinically significant flare of psoriasis during the 12 weeks before baseline.
- •Use of tanning booths for at least 4 weeks before baseline.
- •Concurrent or recent use of any biologic agent within the following periods prior to baseline: etanercept <28 days; infliximab, adalimumab, certolizumab pegol, or alefacept <60 days; golimumab <90 days; rituximab <12 months; secukinumab <5 months; or any other biologic agent (e.g., ustekinumab) <5 half lives.
- •Have prior use of IL-23p19 antagonists (e.g., guselkumab, tildrakizumab, risankizumab), or have any condition or contraindication as addressed in the local labeling for guselkumab that would preclude the participant from participating in this protocol.
- •Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have received treatment with ixekizumab.
- •Have previously failed to respond to an IL-17 antagonist, per investigator assessment.
- •Have had a live vaccination within 12 weeks of baseline.
- •Have a known allergy or hypersensitivity to any biologic therapy.
- •Have had any major surgery within 8 weeks of baseline.
- •Have had a serious infection, have been hospitalized, or have received intravenous antibiotics for an infection within 12 weeks of baseline.
- •Are women who are pregnant, or who are lactating (breast-feeding).
研究组 & 干预措施
Ixekizumab
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20.
The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
干预措施: Ixekizumab (Drug)
Guselkumab
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16.
The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
干预措施: Guselkumab (Drug)
Guselkumab
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16.
The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100)
时间窗: Week 12
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.
次要结局
- Percentage of Participants Achieving PASI 100(Week 24)
- Percentage of Participants Achieving PASI 75(Week 2)
- Percentage of Participants Achieving PASI 90(Week 8)
- Percentage of Participants Achieving Static Physician Global Assessment (sPGA) (0)(Week 12)
- Percentage of Participants Achieving PASI 50(Week 1)