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

Launched by QILU PHARMACEUTICAL (HAINAN) CO., LTD. · May 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called QLG2198 for adults with chronic kidney disease who experience moderate to severe itching, known as uremic pruritus. The study is taking place at multiple locations and will last for a total of 26 weeks, including a 12-week initial phase where neither the participants nor the researchers know who is receiving the treatment or a placebo (a substance with no therapeutic effect). After this, there will be an additional 14 weeks where all participants will know they are receiving the treatment, followed by a 1-week follow-up.

To be eligible for the trial, participants need to be adults aged between 18 and 80 who have been on hemodialysis (a treatment for kidney failure) three times a week for at least 12 weeks. Women must not be pregnant or breastfeeding and should agree to use birth control during the study. Participants should have a stable body weight and not plan on getting a kidney transplant during the study. Throughout the trial, participants will have regular check-ins to see how they are responding to the treatment and to monitor their overall health. This study aims to find out if QLG2198 can help reduce itching in patients undergoing hemodialysis.

Gender

ALL

Eligibility criteria

• 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.

Trial Officials