KPL-716-C202: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Pilot Study to Investigate the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Diseases Characterized by Chronic Pruritus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 14
- 主要终点
- Change From Baseline in Weekly Average WI-NRS at Week 8
研究概览
简要总结
Participants with diseases characterized by chronic pruritus experiencing moderate to severe pruritus will be enrolled in this pilot Phase 2 study.
The diseases characterized by chronic pruritus investigated in this pilot study currently include chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 to 75 years
- •Have clinical diagnosis of chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs) for at least 6 months
- •Moderate to severe pruritus
- •Female participants of childbearing potential must have a negative pregnancy test, be nonlactating, and have agreed to use a highly effective method of contraception, as specified in the protocol, from the Screening Visit until 10 weeks after final study drug administration
- •Able to comprehend and willing to sign an Informed Consent Form and able to abide by the study restrictions and comply with all study procedures for the duration of the study
排除标准
- •Use of prohibited medications within the indicated timeframe from Day 1 to the End of Study
- •Is currently using medication known to cause pruritus
- •Has any inflammatory, pruritic, and/or fibrotic skin condition other than the diagnosis that defines inclusion
- •Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit
- •Has an active infection, including skin infection
- •Any medical or psychiatric condition which, in the opinion of the Investigator or the Sponsor, may place the participant at increased risk as a result of study participation, interfere with study participation or study assessments, affect compliance with study requirements, or complicate interpretation of study results
研究组 & 干预措施
KPL-716
Weekly for 8 weeks
干预措施: KPL-716 (Drug)
Placebo
Weekly for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Weekly Average WI-NRS at Week 8
时间窗: Baseline, Week 8
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Percent Change From Baseline in Weekly Average WI-NRS at Week 8
时间窗: Baseline, Week 8
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
次要结局
- Change From Baseline in Sleep Loss VAS Over Time(Baseline, Weeks 1-8, 10, 12, 14, 16, 18)
- Percent Change From Baseline in Weekly Average WI-NRS Over Time(Baseline, Weeks 1-18)
- Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time(Baseline, Weeks 1-8, 10, 12, 14, 16, 18)
- Percent Change From Baseline in Sleep Loss VAS Over Time(Baseline, Weeks 1-8, 10, 12, 14, 16, 18)
- Change From Baseline in Weekly Average WI-NRS Over Time(Baseline, Weeks 1-18)
- Percent Change From Baseline in Pruritus VAS Over Time(Baseline, Weeks 1-8, 10, 12, 14, 16, 18)
- Change From Baseline in 5-D Pruritus Total Score Over Time(Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18)
- Percent Change From Baseline in 5-D Pruritus Total Score Over Time(Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18)
- Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time(Baseline, Weeks 1-18)
- Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only(Baseline, Weeks 1-18)
- Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only(Baseline, Weeks 1-18)
- Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time(Baseline, Weeks 1-18)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time(Baseline, Weeks 4, 8, 12, 16, 18)
- Percent Change From Baseline in DLQI Total Score Over Time(Baseline, Weeks 4, 8, 12, 16, 18)
- Change From Baseline in ItchyQoL Total Score Over Time(Baseline, Weeks 4, 8, 12, 16, 18)
- Percent Change From Baseline in ItchyQoL Total Score Over Time(Baseline, Weeks 4, 8, 12, 16, 18)
- Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time(Baseline, Weeks 1-18)
- Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time(Baseline, Weeks 1-18)
- Change From Baseline in Weekly Average of Sleep Quality NRS Over Time(Baseline, Weeks 1-18)