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

NCT ID: NCT06446310

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-18
• Study Completion Date: 2025-08-03

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.

Conditions

Uremic Pruritus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

12-weeks double-blind period-QLG2198

Interventions:

Drug: QLG2198 Injection

Group Type: EXPERIMENTAL

QLG2198

Intervention Type: 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.

12-weeks double-blind period- placebo

Interventions:

Drug: Placebo Injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

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

Interventions:

Drug: QLG2198 Injection

Group Type: EXPERIMENTAL

QLG2198

Intervention Type: 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.

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical (Hainan) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zuo Li

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Wang Rong

Role: PRINCIPAL_INVESTIGATOR

Shandong Provincial Hospital

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Jieyang People's Hospital

Jieyang, Guangdong, China

Site Status: RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wu Yidi, M.M

Role: CONTACT

yidi.wu@qilu-pharma.com

16653176910

Jiang xiaoning, P.M

Role: CONTACT

xiaoning.jiang@qilu-pharma.com

13791914950

Facility Contacts

Zuo LI

Role: primary

zuolimd@hotmail.com

Liu Qinghua

Role: primary

Wang Rong

Role: primary

wrjlsd@163.com

Other Identifiers

QLG2198-301

Identifier Type: -

Identifier Source: org_study_id