A Multicenter, Open-Label, Post Marketing Clinical Trial to Evaluate the Efficacy And Safety Of Ixekizumab in Patients With Generalized Pustular Psoriasis and Erythrodermic Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 7
- 主要终点
- Maintenance Dosing Period: Number of Participants Who Improved Global Improvement Score (GIS) at Least 1 Point From Week 12 Through Week 20 and With ≤2 of GIS
研究概览
简要总结
The reason for this study is to see if the study drug ixekizumab is safe and effective in participants with generalized pustular psoriasis and erythrodermic psoriasis.
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
- •Present with GPP or EP based on an investigator-confirmed diagnosis and meet the associated criteria
- •GPP: Meet the criteria for GPP set by Ministry of Health, Labour and Welfare (MHLW) at screening and baseline regardless of IL-36 mutation status.
- •EP: Diagnosed to have BSA ≥80% involvement (with inflammatory erythema) at screening and baseline.
- •Candidates 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
- •History of drug-induced psoriasis
- •Concurrent or recent use of any biologic agent
- •Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
- •Have previously received ixekizumab
- •Serious disorder or illness other than psoriasis
- •Serious infection within the last 12 weeks
- •Breastfeeding or nursing (lactating) women
研究组 & 干预措施
Ixekizumab
Induction Dosing Period:
Participants received 160 milligrams (mg) ixekizumab subcutaneously (SC) as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10.
Maintenance Dosing Period:
Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study.
Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
干预措施: Ixekizumab (Drug)
结局指标
主要结局
Maintenance Dosing Period: Number of Participants Who Improved Global Improvement Score (GIS) at Least 1 Point From Week 12 Through Week 20 and With ≤2 of GIS
时间窗: Week 12 through Week 20
GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline.
次要结局
- Maintenance Dosing Period: Number of Participants With GIS Grade 1: Resolved(Week 20)
- Maintenance Dosing Period: Number of Participants Who Achieved at Least a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75)(Week 20)
- Maintenance Dosing Period: Number of Participants With GIS Grade 3: Unchanged(Week 20)
- Maintenance Dosing Period: Number of Participants With GIS Grade 4: Worsened(Week 20)
- Maintenance Dosing Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score(Baseline, Week 20)
- Generalized Pustular Psoriasis (GPP) Only: Change From Baseline on Generalized Pustular Psoriasis Severity Index(Baseline, Week 20)
- Maintenance Dosing Period: Number of Participants With GIS Grade 2: Improved(Week 20)
- Maintenance Dosing Period: Change From Baseline in Psoriasis Scalp Severity Index (PSSI) in Participants With Scalp Involvement at Baseline(Baseline, Week 20)
- Maintenance Dosing Period: Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis Body Surface Area (BSA) Involvement of Psoriasis(Baseline, Week 20)
- Maintenance Dosing Period: Number of Participants Who Achieved Static Physician Global Assessment (sPGA) of (0, 1)(Week 20)
- Maintenance Dosing Period: Number of Participants Who Developed Neutralizing Anti-Ixekizumab Antibody (NAb)(Week 20)
- Maintenance Dosing Period: Number of Participants Who Developed Treatment-Emergent Anti-Ixekizumab Antibodies (TE-ADA)(Week 20)