Clinical trial NCT06446310: Phase 3 Study of QLG2198 in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
Official title: A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase 3, Clinical Study of QLG2198 in Haemodialysis Adult Subjects With Moderate-to-Severe Pruritus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Uremic Pruritus
Lead sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-06
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in the weekly mean of the Worst Itch Numeric Rating Scale (WI-NRS) score
timeFrame: Week 4 of double-blind period
Secondary outcomes:
measure: Proportion of subjects achieving ≥3-point improvement from baseline with respect to the weekly mean of the WI-NRS
timeFrame: Week 4 、Week 8、 Week 12 of double-blind period
measure: Proportion of subjects achieving ≥4-point improvement from baseline with respect to the weekly mean of the WI-NRS
timeFrame: Week 4 、Week 8、 Week 12 of double-blind period
measure: Change from baseline in itch-related Quality of Life (QoL) assessed by the 5-D itch scale total score
timeFrame: Week 4 、Week 8、Week 12 of double-blind period,Week 4 、Week 8、Week 12 、Week 15 of open-label extension period
measure: Change from baseline in itch-related QoL assessed by the Skindex-10 scale total score
timeFrame: Week 4 、Week 8、 Week 12 of double-blind period,Week 4 、Week 8、Week 12 、Week 15 of open-label extension period
measure: Patient Global Impression of Change
timeFrame: End of double-blind period, week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Jieyang
country: China
facility: Jieyang People's Hospital
state: Guangdong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
affiliation: Peking University People's Hospital
name: Zuo Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Provincial Hospital
name: Wang Rong
role: PRINCIPAL_INVESTIGATOR
References: