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

NCT06446310 | Recruiting Phase 3

• 1 other identifier: QLG2198-301
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 3

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.

Conditions

Uremic Pruritus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Proportion of subjects achieving ≥3-point improvement from baseline with respect to the weekly mean of the WI-NRS

  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

  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

  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

  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

  End of double-blind period, week 12

Study Arms (3)

12-weeks double-blind period-QLG2198

EXPERIMENTAL

Interventions: Drug: QLG2198 Injection

Drug: QLG2198

12-weeks double-blind period- placebo

PLACEBO COMPARATOR

Interventions: Drug: Placebo Injection

Drug: Placebo

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

EXPERIMENTAL

Interventions: Drug: QLG2198 Injection

Drug: QLG2198

Interventions

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

Placebo 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

12-weeks double-blind period- placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical (Hainan) Co., Ltd.: lead

Study Sites (3)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Jieyang People's Hospital

Jieyang, Guangdong, China

RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

RECRUITING

Study Officials

• Zuo Li

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Wang Rong

  Shandong Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wu Yidi, M.M

CONTACT

16653176910; yidi.wu@qilu-pharma.com

Jiang xiaoning, P.M

CONTACT

13791914950; xiaoning.jiang@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: June 18, 2024
• Primary Completion: February 21, 2025
• Study Completion: August 3, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)