A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 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
- 1,296
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)
研究概览
简要总结
This study will assess the safety and efficacy of LY2439821 compared to placebo in participants with moderate to severe, chronic 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 (IL)-17 antagonists, including LY2439821
- •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 milligrams (mg) Ixekizumab Dosing Regimen 1 (Q2W)
Administered as two 80-mg subcutaneous (SC) injections at Week 0, then one 80-mg SC injection per Dosing Regimen 1 [every 2 weeks (Q2W)] up to and including Week 10. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 [every 4 weeks (Q4W)] or Dosing Regimen 3 [every 12 weeks Q12W)].
干预措施: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3 (Drug)
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
Administered as two 80-mg SC injections at Week 0, then one 80-mg SC injection per Dosing Regimen 2 (Q4W) up to and including Week 10. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 (Q4W) or Dosing Regimen 3 (Q12W).
干预措施: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3 (Drug)
80 mg Ixekizumab Dosing Regimen 3 (Q12W)
Dosing Regimen 3 (Q12W) is not used until Week 12. At Week 12, participants who were re-randomized to this arm were administered one 80-mg SC injection Q12W.
干预措施: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3 (Drug)
Placebo
Administered as 2 SC injections at Week 0, then 1 SC injection per Dosing Regimen 1 (Q2W) up to and including Week 10. At Week 12, arm is re-randomized to placebo or Dosing Regimen 2 (Q4W).
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)
时间窗: Week 12
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI)
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 separately and the scores 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). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.
次要结局
- Percentage of Participants Achieving an sPGA of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)(Week 12)
- Percentage of Participants Maintaining sPGA 0 or 1 After Re-Randomization at Start of Maintenance Dosing Period(Week 60)
- Percentage of Participants With Itch Numeric Rating Scale (Itch NRS) Score ≥4 Point Reduction From Baseline(Baseline, Week 12)
- Percent of Body Surface Area (BSA) Involvement of Ps(Week 12)
- Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16)(Baseline, Week 12)
- Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Score(Baseline, Week 12)
- Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)(Weeks 12: Day 84 and Week 24: Day 168)
- Percentage of Participants With Anti-ixekizumab Antibodies(Baseline through Week 12)
- Percentage of Participants Achieving PASI 90% (PASI90) or 100% (PASI100) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: PASI)(Week 12)
- Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes (PRO)(Baseline, Week 12)
- Change From Baseline in Nail Psoriasis Severity Index (NAPSI)(Baseline, Week 12)
- Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA)(Baseline, Week 12)
- Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75), or 100% (PPASI100) Improvement(Week 12)
- Change From Baseline in Psoriasis Scalp Severity Index (PSSI)(Baseline, Week 12)
- Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS)(Baseline, Week 12)