A 52-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab 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
- 302
- 试验地点
- 2
- 主要终点
- Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab 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
- •Chronic plaque psoriasis for at least 6 months before baseline
- •Failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate, or phototherapy)
- •Psoriasis Area Severity Index (PASI) score at least 10 at screening and at baseline
- •Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 15 weeks after stopping treatment
排除标准
- •Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis
- •History of drug-induced psoriasis
- •Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks before baseline and during the study
- •Have received systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks of baseline, or have had topical psoriasis treatment within the 2 weeks of baseline
- •Concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days; infliximab, adalimumab, or alefacept <60 days; golimumab <90 days; rituximab <12 months; or any other biologic agent <5 half-lives prior to baseline
- •Have prior use of ustekinumab, or have any condition or contraindication to ustekinumab 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- •Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, have participated in any study investigating other interleukin (IL)-17 or IL-12/23 antagonists, or have received treatment with other IL-17 or IL-12/23 antagonists
- •Have had a live vaccination within 12 weeks of baseline, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study
- •Have had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months of baseline or intend to have vaccination with BCG during the course of the study or within 12 months of completing treatment in this study
- •Have a known allergy or hypersensitivity to latex
- •Have had any major surgery within 8 weeks of baseline or will require such during the study
- •Have active or history of malignant disease within 5 years prior to baseline
- •Significant uncontrolled disorder
- •Ongoing infection or serious infection within 12 weeks of baseline; serious bone or joint infection within 24 weeks of baseline
- •Are women who are lactating or breast-feeding
研究组 & 干预措施
Ustekinumab
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
干预措施: Ustekinumab (Drug)
Ustekinumab
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
干预措施: Placebo (Drug)
Ixekizumab
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52.Placebo for ustekinumab injections will be used for blinding.
干预措施: Ixekizumab (Drug)
Ixekizumab
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52.Placebo for ustekinumab injections will be used for blinding.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
时间窗: Week 12
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
次要结局
- Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) With at Least a 2-Point Improvement From Baseline(Week 12)
- Percentage of Participants With a sPGA (0) Remission(Week 12)
- Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score(Baseline, Week 12)
- Percentage of Participants With Dermatology Life Quality Index (DLQI) (0,1)(Week 12)
- Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score;(Baseline, Week 12)
- Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score(Baseline, Week 12)
- Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale.(Baseline, Week 12)
- Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" Psoriasis (PSO) -Index(Baseline, Week 12)
- Percentage of Participants With a ≥75% Improvement in PASI (PASI 75) From Baseline(Week 12)
- Percentage of Participants With a 100% Improvement of PASI (PASI 100) From Baseline(Week 12)
- Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score(Baseline, Week 12)
- Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis(Baseline, Week 12)
- Change From Baseline in Itch Numeric Rating Scale (NRS)(Baseline, Week 12)
- Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) United Kingdom(UK) Population-based Index Score(Baseline, Week 12)
- Change From Baseline on the Skin Pain Visual Analog Scale (VAS) (0,100)(Baseline, Week 12)
- Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Depression Subscale(Baseline, Week 12)
- Change From Baseline on Patient Global Assessment of Disease Severity (PatGA)(Baseline, Week 12)
- Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Absenteeism(Baseline, Week 12)
- Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score(Baseline, Week 12)
- Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) VAS(Baseline, Week 12)
- Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Work Impairment Score.(Baseline, Week 12)
- Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Presenteeism(Baseline, Week 12)
- Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Impairment in Activities Performed Outside of Work(Baseline, Week 12)