Phase 3 Study of QLG2198 in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
- Registration Number
- NCT06446310
- Lead Sponsor
- Qilu Pharmaceutical (Hainan) Co., Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 194
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 12-weeks double-blind period-QLG2198 QLG2198 Interventions: Drug: QLG2198 Injection 12-weeks double-blind period- placebo Placebo Interventions: Drug: Placebo Injection 14-weeks open-label period following the double-blind period- QLG2198 QLG2198 Interventions: Drug: QLG2198 Injection
- Primary Outcome Measures
Name Time Method Change from baseline in the weekly mean of the Worst Itch Numeric Rating Scale (WI-NRS) score 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."
- Secondary Outcome Measures
Name Time Method 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 The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores.
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 The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores.
Patient Global Impression of Change End of double-blind period, week 12 The Patient Global Impression of Change is a questionnaire that assesses the change in itch compared to the itch at the start of the study.The scale has only 1 item, and the patient is asked to mark the category that best describes the change in itch ranging from "Very Much Improved" to"Very Much Worse"
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 The 5-D itch scale is a questionnaire where patients assess the 5 dimensions of itch (degree, duration, direction, disability, and distribution).The total score is the sum of the numeric value of each answered question.
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 The Skindex-10 scale is a questionnaire that measures QoL in relationship to the itch intensity.Patients are asked to mark 1 of 7 boxes numbered from 0(labeled with the anchor phrase "never bothered") to 6 (labeled as "always bothered") for each of the 10 questions describing how often they have been bothered by their itch and its impact over the past week. The total score is the sum of the numeric value of each answered question. The total score is subdivided into 3 domain scores, which are sums of the scores of the following questions: disease domain (questions 1 to 3),mood/emotional distress domain (questions 4 to 6), and social functioning domain (questions 7 to 10).
Trial Locations
- Locations (3)
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Jieyang People's Hospital
🇨🇳Jieyang, Guangdong, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China