A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of HSK21542 Injection in Liver Disease Subjects With Pruritus

NCT04999787 | Completed Phase 2

• 1 other identifier: HSK21542-204
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multi-center, randomized, double-blind, placebo-controlled study. About 90 liver disease subjects with moderate or above pruritus are planned to be enrolled. They will be randomized to two dose groups (0.3 μg/kg and 0.6 μg/kg) and a placebo control group at a 1:1:1 ratio, with about 30 subjects in each group.

Conditions

Pruritus

Outcome Measures

Primary Outcomes (6)

• Changes in daily Worst Itching Intensity Numerical Rating Scale (WI-NRS) scores from baseline during the administration period

  In the NRS score, 0-10 represents different degrees of itching, the larger the number, the more severe the itching

  Day 1 to Day 28

• The proportion of subjects whose daily WI-NRS scores improve by ≥ 3 points and ≥ 4 points compared with baseline during the administration period

  Day 1 to Day28

• Area under curve (AUC) of daily WI-NRS scores during the administration period

  Day 1 to Day28

• Changes in WI-NRS per unit time (per day) from baseline during the administration period

  Day 1 to Day 28

• Changes in quality of life (evaluated by Skindex-16 scale) from baseline during the administration period

  Day 1 to Day 28

• Changes in daily WI-NRS scores from baseline during the follow-up period

  Day 29 to Day 31

Study Arms (2)

HSK21542

EXPERIMENTAL

HSK21542-0.3 μg/kg，HSK21542-0.6 μg/kg

Drug: HSK21542

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HSK21542 DRUG

HSK21542-0.3 μg/kg，HSK21542-0.6 μg/kg

HSK21542

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 and ≤ 75 years old, male or female;
• Body mass index (BMI): ≥ 18 kg/m2 and ≤ 35 kg/m2;
• Suffering from liver diseases with itching, including but not limited to viral hepatitis, autoimmune liver disease, drug-induced liver disease, alcoholic liver disease, and other liver diseases;
• The mean baseline WI-NRS score before randomization suggests moderate to severe itching (≥ 4 points) and the last two WI-NRS scores ≥ 4 points.
• Subjects who are willing to sign an informed consent form in written form fully understand the objectives and purposes of the study, and are willing to comply with the study protocol before any of the study-related procedures to start.

You may not qualify if:

• Decompensated hepatic cirrhosis in the following cases:
• History of liver transplant, expecting a liver transplant surgery, or the current model for end-stage liver disease (MELD) score ≥ 18;
• Grade 3 ascites;
• History of gastrointestinal hemorrhage (excluding haemorrhoidal haemorrhage) within one month before randomization;
• Hepatic encephalopathy;
• Having dermatitis atopic, chronic urticaria, psoriasis or other skin diseases that the investigator determines will disturb the assessment of itching or having itching caused by other diseases.
• History of allergy to opioids, such as urticaria;
• Cannot ensure the stable use of drugs for the treatment of baseline liver diseases from 4 weeks before the lead-in phase to the end of the follow-up period, such as ursodeoxycholic acid (UCDA), antiviral drugs (excluding interferon), fibrates, etc.;
• Cannot ensure the stable use of drugs that may affect the efficacy or safety evaluations from the first 14 days of the lead-in phase to the end of the follow-up period, such as antipsychotics, sedative hypnotics, anxiolytics, antidepressants (excluding selective serotonin reuptake inhibitors), immunosuppressants/immunomodulators (such as systemic glucocorticoid therapy \[excluding topical application\], ciclosporin A, azathioprine, methotrexate, etc.);
• Using drugs with unclear half-life that may affect the efficacy evaluation within 14 days before the lead-in period, or drugs that affect the efficacy evaluation before randomization, and the last time of use is shorter than 5 half-lives from the lead-in phase (refer to the specific drug labeling), including but not limited to bile acid binding resin (colestyramine, etc.), pregnane X receptor (PXR) agonist (rifampicin, etc.), selective serotonin reuptake inhibitor (SSRIs) (sertraline, etc.), antihistamines, gabapentin, pregabalin, interferon, obeticholic acid or other opioids;
• Using the following topical drugs within 3 days before the lead-in phase: antihistamines and glucocorticoids;
• Having received traditional Chinese medicine treatment, physical phototherapy or artificial liver treatment that may affect the efficacy evaluation within 14 days before randomization;
• Complicated with other serious underlying diseases that the investigator judges may increase the risk of the trial, affect the compliance of the subjects with the protocol or affect the subjects with completion of the trial, including but not limited to malignant tumors (excluding tumors that had been cured \[no evidence of disease recurrence within 5 years\]), serious cardiovascular and cerebrovascular diseases, mental and neurological disorders, etc.;
• Complicated with uncontrolled severe infections (including severe abdominal infection, upper respiratory tract infection, lower respiratory tract infection, urinary system infection, etc.);
• Itching secondary to obstruction of bile duct (excluding primary sclerosing cholangitis (PSC));

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

The first hospital of Jilin University

Changchun, China

Location

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 11, 2021
• Study Start: September 16, 2021
• Primary Completion: August 3, 2022
• Study Completion: August 3, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

CN (1)