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

Qilu Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Uremic Pruritus

Treatments: Drug: Placebo; Drug: QLG2198

Study type: Interventional

Funder types: Industry

Identifiers

NCT06446310

QLG2198-301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 194 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

194 participants in 3 patient groups, including a placebo group

12-weeks double-blind period-QLG2198

Experimental group

Description:

Interventions: Drug: QLG2198 Injection

Treatment:

Drug: QLG2198

12-weeks double-blind period- placebo

Placebo Comparator group

Description:

Interventions: Drug: Placebo Injection

Treatment:

Drug: Placebo

14-weeks open-label period following the double-blind period- QLG2198

Experimental group

Description:

Interventions: Drug: QLG2198 Injection

Treatment:

Drug: QLG2198