NCT01624233已完成3 期
A Multicenter, Open-Label, Long-Term Study to Evaluate the Efficacy and Safety of LY2439821 in Japanese Patients With Moderate-to-Severe Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI)
研究概览
简要总结
This study will assess the safety and efficacy of ixekizumab in participants with moderate to severe psoriasis in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Candidates for phototherapy and/or systemic therapy
- •Present with chronic psoriasis based on a confirmed psoriasis diagnosis for at least 6 months prior to enrollment
- •At least 10% Body Surface Area (BSA) of Psoriasis at screening and at enrollment for participants with plaque psoriasis
- •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 enrollment for participants with plaque psoriasis
排除标准
- •History of drug-induced psoriasis
- •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 enrollment for participants with plaque psoriasis
- •Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
- •Have participated in any study with interleukin-17(IL-17) antagonists, including ixekizumab
- •Serious disorder or illness other than psoriasis
- •Serious infection within the last 3 months
- •Breastfeeding or nursing (lactating) women
- •Clinically significant flare of psoriasis during the 12 weeks prior to enrollment for participants with plaque psoriasis
研究组 & 干预措施
80 mg ixekizumab
Experimental
Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, followed by one 80 mg SC injection per Dosing Regimen 1 up to Week 12. Then administered by one 80 mg SC injection per Dosing Regimen 2 from Week 12 up to Week 52, and for up to 192 weeks following disease relapse occurring during a drug-free period beyond 52 weeks.
干预措施: 80 mg ixekizumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI)
时间窗: Week (Wk) 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=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 Achieving ≥75% Improvement in PASI(Wks 24 and 52)
- Change From Baseline in Percent of BSA Involvement(Baseline, Wk 100; Baseline, Retreatment Wk 192)
- Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab(Pre-dose at Wks 12 (Day 84) and Wks24 (Day 168))
- Number of Participants With Anti-Ixekizumab Antibodies(Baseline through Wk 52)
- Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA)(Wks 12, 24 and 52)
- Change From Baseline in Percent of Body Surface Area (BSA) Involvement(Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score(Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52)
- Change From Baseline in Nail Psoriasis Severity Index (NAPSI)(Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52)
- Change From Baseline in PSSI(Baseline, Wk 100; Baseline, Retreatment Wk 192)
- Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20](Wks 12, 24 and 52)
- Change From Baseline in Itch NRS Score(Baseline, Wk 100; Baseline, Retreatment Wk 192)
- Percent of Participants Achieving PASI 90% and 100% Improvement(Wks 12, 24 and 52)
- Change From Baseline in Participants Assessment of Joint Pain Visual Analog Scale (VAS) (Efficacy of Ixekizumab in Participants With PsA Pain VAS)(Baseline, Wk 12; Baseline, Wk 52)
- Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement(Wk 100 and Retreatment Wk 192)
- Change From Baseline in DLQI Score(Baseline, Wk 100; Baseline, Retreatment Wk 192)
- Change From Baseline in Participants Assessment of Joint Pain VAS(Baseline, Wk 100; Baseline, Retreatment Wk 192)
- Number of Participants Achieving ACR20(Wk 100 and Wk Retreatment Wk 192)
- Change From Baseline in Psoriasis Scalp Severity Index (PSSI)(Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52)
- Change From Baseline in Itch Numeric Rating Scale (NRS) Score(Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52)
- Percentage of Participants With sPGA (0 or 1) and sPGA (0)(Wk 100 and Retreatment Wk 192)
- Change From Baseline in QIDS-SR16 Score(Baseline, Wk 100; Baseline, Retreatment Wk 192)
- Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)](Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52)
- Change From Baseline in NAPSI(Baseline, Wk 100; Baseline, Retreatment Wk 192)
研究者
研究点 (1)
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