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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12-weeks double-blind period-QLG2198 | Experimental | Interventions: Drug: QLG2198 Injection |
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| 12-weeks double-blind period- placebo | Placebo Comparator | Interventions: Drug: Placebo Injection |
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| 14-weeks open-label period following the double-blind period- QLG2198 | Experimental | Interventions: Drug: QLG2198 Injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLG2198 | Drug | Participants receive QLG2198 three times a week (0,5 micrograms/kg dry body weight). QLG21988 is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the weekly mean of the Worst Itch Numeric Rating Scale (WI-NRS) score | 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." | Week 4 of double-blind period |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving ≥3-point improvement from baseline with respect to the weekly mean of the WI-NRS | The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wu Yidi, M.M | Contact | 16653176910 | yidi.wu@qilu-pharma.com | |
| Jiang xiaoning, P.M | Contact | 13791914950 | xiaoning.jiang@qilu-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Zuo Li | Peking University People's Hospital | Principal Investigator |
| Wang Rong | Shandong Provincial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Placebo | Drug | Participants receive Placebo three times a week (0,5 micrograms/kg dry body weight). Placebo is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis |
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The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores. |
| Week 4 、Week 8、 Week 12 of double-blind period |
| Change from baseline in itch-related Quality of Life (QoL) assessed by the 5-D itch scale total score | 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. | 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 | 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). | Week 4 、Week 8、 Week 12 of double-blind period,Week 4 、Week 8、Week 12 、Week 15 of open-label extension period |
| Patient Global Impression of Change | 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" | End of double-blind period, week 12 |
| Jieyang People's Hospital | Recruiting | Jieyang | Guangdong | China |
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| Shandong Provincial Hospital | Recruiting | Jinan | Shandong | China |
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