Early Onset of Clinical Improvement With Ixekizumab 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
- 12
- 试验地点
- 1
- 主要终点
- Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score
研究概览
简要总结
To detect onset of activity of ixekizumab in participants with moderate-to-severe plaque psoriasis and to document the same using sequential photographic images.
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
- None
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 moderate-to-severe plaque psoriasis based on a confirmed (by a dermatologist) diagnosis of chronic plaque psoriasis for at least 6 months prior to baseline
- •Active psoriatic skin lesions of plaque psoriasis (Ps)
- •Are a candidate for phototherapy and/or systemic therapy
- •Men must agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
- •Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
排除标准
- •Are unable to commit to the photography schedule for the duration of the study
- •Have participated in any study with interleukin 17 (IL-17) or (IL-23) antagonists, including ixekizumab
- •Serious disorder or illness other than psoriasis
- •Serious infection within the last 3 months
- •Breastfeeding or nursing (lactating) women
研究组 & 干预措施
Ixekizumab Dosing Q2W
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q2W) every 2 weeks through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
干预措施: Ixekizumab (Drug)
Ixekizumab Dosing Q4W
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q4W) every 4 weeks through week 44.
干预措施: Ixekizumab (Drug)
结局指标
主要结局
Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score
时间窗: Baseline through Week 12
The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 Numeric Rating Score (NRS) the severity of their psoriasis "today" from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.
次要结局
- Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score(Baseline, Week 12)
- Mean Change From Baseline on the Dermatology Life Quality Index (DLQI)(Baseline, Week 12)
- Time to at Least a 2 Point Improvement on the PatGA Score(Baseline though Week 12)
- Mean Change From Baseline in Percent Body Surface Area (%BSA)(Baseline, Week 12)
- Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI)(Baseline, Week 12)