A 2-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate-to-Severe Pruritus in Adult Subjects With Notalgia Paresthetica
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 214
- 试验地点
- 2
- 主要终点
- Proportion of subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score
研究概览
简要总结
This is a 2-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin for moderate-to-severe pruritus in adult subjects with NP.
详细描述
Part A of this study will evaluate the benefit-risk of 3 doses of difelikefalin compared to placebo. The dose with the best benefit-risk profile will be further evaluated in Part B. Part A of this study comprises a 28-day Screening Period, a 7-day Run-in Period, an 8-week Double-blind Treatment Period, a 2-week Treatment Discontinuation Period, and a Safety Follow-up Visit (14 days after the last dose of study treatment).
Part B of this study will evaluate the efficacy, safety, and tolerability of oral difelikefalin. The dose of oral difelikefalin to be assessed in Part B will depend on the results of Part A. Part B of this study comprises a 28-day Screening Period, a 7-day Run-in Period, an 8-week Double-blind Treatment Period, up to a 52-week OLE Period, and a Safety Follow-up Visit.
Subjects who participated in Part A of the study may not participate in Part B.
All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for inclusion into the study, a patient must meet the following criteria:
- •Subject has clinically confirmed diagnosis of active Notalgia Paresthetica;
- •Subject has a history of chronic pruritus due to Notalgia Paresthetica;
- •Subject has moderate to severe pruritus;
- •Female subject is not pregnant or nursing during any period of the study.
排除标准
- •A patient will be excluded from the study if any of the following criteria are met:
- •Subject has pruritus attributed to a cause other than Notalgia Paresthetica;
- •Subject has any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
研究组 & 干预措施
Difelikefalin 2.0 mg tablets
Oral difelikefalin 2.0 mg tablet administered twice daily
干预措施: difelikefalin 2.0 mg tablets (Drug)
Difelikefalin 1.0 mg tablets
Oral difelikefalin 1.0 mg tablet administered twice daily
干预措施: difelikefalin 1.0 mg tablets (Drug)
Difelikefalin 0.25 mg tablets
Oral difelikefalin 0.25 mg tablet administered twice daily
干预措施: difelikefalin 0.25 mg tablets (Drug)
Placebo tablets
Oral placebo tablet administered twice daily
干预措施: Placebo tablets (Drug)
结局指标
主要结局
Proportion of subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score
时间窗: Baseline, Week 8
次要结局
- Proportion of subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 4 in Part B(Baseline, Week 4)
- Proportion of subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 2 in Part B(Baseline, Week 2)
- Change from Baseline in the Numeric Rating Scale of Burning Sensation and Skin Tingling at Week 8 in Part B(Baseline, Week 8)
- Proportion of Subjects with H-IGA of Clear or Almost Clear at Week 8 in Part B(Week 8)
- Proportion of ≥4-point Improvement in Daily I-NRS at Day 2 in Part B(Day 2)
- Proportion of subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 1 in Part B(Baseline, Week 1)