A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase 3, Clinical Study of QLG2198 in Haemodialysis Adult Subjects With Moderate-to-Severe Pruritus
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 194
- 试验地点
- 3
- 主要终点
- Change from baseline in the weekly mean of the Worst Itch Numeric Rating Scale (WI-NRS) score
研究概览
简要总结
This a multicentre study that consists of a 12-week double-blind period, and a 14-week open-label extension period and a 1-week follow-up period.
详细描述
Total study duration for a single subject is 31 to 32 weeks with a 4-week screening period, a 12-week double-blind period, a 14-week open-label extension period, and a 1-week follow-up period.
QLG2198 will be administered in the double-blind and open-label period 3 times a week at the end of each dialysis session. The total dose of the investigational product will be determined based on the subject's prescription dry body weight.
The primary objective of the study is:
To evaluate the efficacy and safety of QLG2198 0.5 μg/kg compared to placebo in reducing the intensity of itch in HD subjects with moderate-to-severe pruritus.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with chronic kidney disease (CKD) on HD 3 times weekly for ≥12 weeks prior to screening who can continue HD without changing its frequency or method
- •If female, is not pregnant, or nursing.
- •agrees not to donate sperm or egg after the first dose of investigational product administration until 7 days after the last dose of investigational product, and agrees to use contraceptive method from heterosexual intercourse during the study until 7 days after the last dose of investigational product.
- •Subjects with a prescription dry body weight between 40 and 100 kg
排除标准
- •Planned to receive a kidney transplant during the study.
- •Has localised itch restricted to the palms of the hands.
- •Has pruritus only during the dialysis session
- •Subjects with severe hepatic impairment (Child-Pugh Class C) or concurrent hepatic cirrhosis.
- •Subject is receiving ongoing ultraviolet treatment .
- •Subjects with concurrent malignancy except excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ that has been excised or resected completely.
- •Known or suspected history of alcohol or drug abuse/dependence within 12 months prior to screening.
- •New or change of treatment received for itch within 2 weeks prior to screening.
研究组 & 干预措施
12-weeks double-blind period-QLG2198
Interventions:
Drug: QLG2198 Injection
干预措施: QLG2198 (Drug)
12-weeks double-blind period- placebo
Interventions:
Drug: Placebo Injection
干预措施: Placebo (Drug)
14-weeks open-label period following the double-blind period- QLG2198
Interventions:
Drug: QLG2198 Injection
干预措施: QLG2198 (Drug)
结局指标
主要结局
Change from baseline in the weekly mean of the Worst Itch Numeric Rating Scale (WI-NRS) score
时间窗: Week 4 of double-blind period
The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores.patients will be asked to indicate the intensity of the worst itching they experienced over the past 24 hours by marking one of 11 numbers, from 0 to 10, that best describes it, where "0" is labeled with the anchor phrase "no itching" and "10" is labeled "worst itching imaginable."
次要结局
- Proportion of subjects achieving ≥3-point improvement from baseline with respect to the weekly mean of the WI-NRS(Week 4 、Week 8、 Week 12 of double-blind period)
- Proportion of subjects achieving ≥4-point improvement from baseline with respect to the weekly mean of the WI-NRS(Week 4 、Week 8、 Week 12 of double-blind period)
- Patient Global Impression of Change(End of double-blind period, week 12)
- Change from baseline in itch-related Quality of Life (QoL) assessed by the 5-D itch scale total score(Week 4 、Week 8、Week 12 of double-blind period,Week 4 、Week 8、Week 12 、Week 15 of open-label extension period)
- Change from baseline in itch-related QoL assessed by the Skindex-10 scale total score(Week 4 、Week 8、 Week 12 of double-blind period,Week 4 、Week 8、Week 12 、Week 15 of open-label extension period)