Phase 3 Study of QLG2198 in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus

A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase 3, Clinical Study of QLG2198 in Haemodialysis Adult Subjects With Moderate-to-Severe Pruritus

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.

Study Overview

• Status: Recruiting
• Conditions: Uremic Pruritus
• Intervention / Treatment: Drug: QLG2198; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 194
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Wu Yidi, M.M; Phone Number: 16653176910; Email: yidi.wu@qilu-pharma.com
• Study Contact Backup: Name: Jiang xiaoning, P.M; Phone Number: 13791914950; Email: xiaoning.jiang@qilu-pharma.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking University People's Hospital
      • Contact: Zuo LI; Email: zuolimd@hotmail.com
  • Guangdong
    • Jieyang, Guangdong, China
      • Recruiting
      • Jieyang People's Hospital
      • Contact: Liu Qinghua
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Shandong Provincial Hospital
      • Contact: Wang Rong; Email: wrjlsd@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 12-weeks double-blind period-QLG2198; Interventions: Drug: QLG2198 Injection	Drug: QLG2198; 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.
Placebo Comparator: 12-weeks double-blind period- placebo; Interventions: Drug: Placebo Injection	Drug: Placebo; 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
Experimental: 14-weeks open-label period following the double-blind period- QLG2198; Interventions: Drug: QLG2198 Injection	Drug: QLG2198; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.
• Investigators: Principal Investigator: Zuo Li, Peking University People's Hospital; Principal Investigator: Wang Rong, Shandong Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2024
• Primary Completion (Estimated): February 21, 2025
• Study Completion (Estimated): August 3, 2025

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: QLG2198-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No