search
Back to results

A Study of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis

Primary Purpose

Non-cystic Fibrosis Bronchiectasis (NCFBE)

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HSK31858
placebo
Sponsored by
Haisco Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-cystic Fibrosis Bronchiectasis (NCFBE) focused on measuring HSK31858, NCFBE, phase II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Age ≥18 years and BMI≥18.0 kg/m^2 at the time of signing the ICF. 2. Chest HRCT showed bronchiectasis affecting one or more lobes and was confirmed by a clinician as NCFBE(clinically characterized by chronic cough, expectoration and/or intermittent hemoptysis, with or without shortness of breath and respiratory failure). HRCT was considered effective if the patient had received HRCT in the same hospital within 12 months and screening HRCT is not necessary. 3. Having daily expectoration(with sufficient sputum production at screening, if the subject is unable to produce sputum voluntarily, sample collection can be performed by induced expectoration). 4. Have at least 2 pulmonary exacerbations in the past 12 months before Screening. 5. If long-term treatment with bronchodilators (long-acting β-agonists and/or long-acting muscarinic antagonists) is required, the dose and regimen should remain stable for at least 3 months before the screening visit and throughout the study period. 6. The estimated survival time ≥ 12 months. 7. Women must be post-menopausal, surgically sterile, or using highly effective contraception methods from Day 1 to at least 30 days after the last dose. 8. Males with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose. 9. Give their signed study informed consent to participate. Exclusion Criteria: 1. Have pulmonary hypertension or have a primary diagnosis of COPD or asthma as judged by the Investigator. 2. A history of malignancy (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary carcinoma of the thyroid gland. The patients who had survived lung cancer surgery for at least 5 years without antitumor therapy can enroll in the study ) within 5 years prior to screening or a history of antitumor therapy. 3. Have bronchiectasis due to CF (HRCT showed that the above lung diseases became predominant) as judged by the Investigator. 4. Currently being treated Non-tuberculous Mycobacterial (NTM) pulmonary infections, allergic bronchopulmonary aspergillosis, or tuberculosis (TB), or active and currently symptomatic infections caused by COVID-19. 5. Patients who had experienced any degree of acute exacerbation of bronchiectasis or were developing an acute exacerbation of bronchiectasis before 4 weeks of screening. 6. Patients who had hemoptysis and required medical intervention within 4 weeks prior to screening(except for coughing up minorbloody streaks). 7. Have an abnormal renal function test result (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73m^2) at Screening. 8. Subjects with a history of liver disease or current treatment for liver disease during the screening period, including but not limited to acute or chronic hepatitis, cirrhosis or liver failure, or aspartate aminotransferase (AST) > 2.0×ULN or alanine aminotransferase (ALT) > 2.0×ULN or total bilirubin (TBIL) > 1.5×ULN. 9. Active hepatitis B virus infection (hepatitis B surface antigen positive with HBV-DNA load above the lower limit of detection), active hepatitis C virus infection (HCV antibody positive with HCV-RNA load above the lower limit of detection), or known HIV infection or syphilis infection. 10. Any other unstable clinical condition, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic, psychiatric, or major physiological dysfunction, that the investigator considers to be (a) likely to affect patient safety throughout the study; (b) Influence the results of the study and its interpretation; (c) impeding the patient's ability to complete the entire study. 11. Had participated in a clinical trial of any other drug or medical device in the 3 months prior to the screening (a drug or medical device treated with a clinical trial) or the subject had not been more than 5 half-lives from the last clinical trial of the drug at the time of screening. 12. Medications that may cause hyperkeratosis (e.g., tumor necrosis factor-α antagonists) within 4 weeks prior to screening. 13. Patients who have used a strong inducer or suppressor of CYP3A within 14 days or 5 half-lives of the first investigational drug (whichever is longer). 14. Patients who had smoked an average of 10 cigarettes or more per day in the previous 1 year were screened. 15. Pregnancy and lactation. 16. The subjects were unable to complete the questionnaires due to their limited educational level, or the subjects and their families failed to fill in the subjects' log cards. 17. Had received live attenuated vaccine within 30 days before randomization. 18. The investigators judged that there were other conditions that were not suitable for participation in the study.

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

HSK31858 20mg

HSK31858 40mg

placebo

Arm Description

multiple oral doses: 20mg/d for 24w

multiple oral doses: 20mg/d for 24w

multiple oral doses for 24w

Outcomes

Primary Outcome Measures

Frequency of pulmonary exacerbations
Number of events per person-time over 24-weeks

Secondary Outcome Measures

Time to first pulmonary exacerbation
Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics
Change from Baseline(Screening) in forced expiratory volume in 1 second (FEV1)
Change from Baseline(Screening) in FEV1 at 24-weeks
Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score
Change from Baseline(Screening) in 24h Sputum Weight and Purulence Score at 24-weeks
Change from Baseline(Screening) in Frequency of Hemoptysis
Change from Baseline(Screening) in Hemoptysis
Change from Baseline in the Respiratory Symptoms Domain Score of the Quality of Life (QOL) Bronchiectasis questionnaire
Change from Baseline Quality of Life (QOL) Bronchiectasis questionnairescore at 24-weeks

Full Information

First Posted
October 27, 2022
Last Updated
December 6, 2022
Sponsor
Haisco Pharmaceutical Group Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05601778
Brief Title
A Study of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis
Official Title
Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of HSK31858 in Participants With Non-cystic Fibrosis Bronchiectasis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haisco Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase II, randomised, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of HSK31858 in non-cystic fibrosis bronchiectasis (NCFBE) participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-cystic Fibrosis Bronchiectasis (NCFBE)
Keywords
HSK31858, NCFBE, phase II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HSK31858 20mg
Arm Type
Experimental
Arm Description
multiple oral doses: 20mg/d for 24w
Arm Title
HSK31858 40mg
Arm Type
Experimental
Arm Description
multiple oral doses: 20mg/d for 24w
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
multiple oral doses for 24w
Intervention Type
Drug
Intervention Name(s)
HSK31858
Intervention Description
HSK31858 is a novel inhibitor of DPP1 developed by Hisco Pharmaceutical and can reduce pulmonary exacerbations over a 24-week treatment period in patients with non-cystic fibrosis bronchiectasis
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
the placebo comparator of study
Primary Outcome Measure Information:
Title
Frequency of pulmonary exacerbations
Description
Number of events per person-time over 24-weeks
Time Frame
24-week treatment period
Secondary Outcome Measure Information:
Title
Time to first pulmonary exacerbation
Description
Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics
Time Frame
24-week treatment period
Title
Change from Baseline(Screening) in forced expiratory volume in 1 second (FEV1)
Description
Change from Baseline(Screening) in FEV1 at 24-weeks
Time Frame
24-week treatment period
Title
Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score
Description
Change from Baseline(Screening) in 24h Sputum Weight and Purulence Score at 24-weeks
Time Frame
24-week treatment period
Title
Change from Baseline(Screening) in Frequency of Hemoptysis
Description
Change from Baseline(Screening) in Hemoptysis
Time Frame
24-week treatment period
Title
Change from Baseline in the Respiratory Symptoms Domain Score of the Quality of Life (QOL) Bronchiectasis questionnaire
Description
Change from Baseline Quality of Life (QOL) Bronchiectasis questionnairescore at 24-weeks
Time Frame
24-week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years and BMI≥18.0 kg/m^2 at the time of signing the ICF. 2. Chest HRCT showed bronchiectasis affecting one or more lobes and was confirmed by a clinician as NCFBE(clinically characterized by chronic cough, expectoration and/or intermittent hemoptysis, with or without shortness of breath and respiratory failure). HRCT was considered effective if the patient had received HRCT in the same hospital within 12 months and screening HRCT is not necessary. 3. Having daily expectoration(with sufficient sputum production at screening, if the subject is unable to produce sputum voluntarily, sample collection can be performed by induced expectoration). 4. Have at least 2 pulmonary exacerbations in the past 12 months before Screening. 5. If long-term treatment with bronchodilators (long-acting β-agonists and/or long-acting muscarinic antagonists) is required, the dose and regimen should remain stable for at least 3 months before the screening visit and throughout the study period. 6. The estimated survival time ≥ 12 months. 7. Women must be post-menopausal, surgically sterile, or using highly effective contraception methods from Day 1 to at least 30 days after the last dose. 8. Males with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose. 9. Give their signed study informed consent to participate. Exclusion Criteria: 1. Have pulmonary hypertension or have a primary diagnosis of COPD or asthma as judged by the Investigator. 2. A history of malignancy (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary carcinoma of the thyroid gland. The patients who had survived lung cancer surgery for at least 5 years without antitumor therapy can enroll in the study ) within 5 years prior to screening or a history of antitumor therapy. 3. Have bronchiectasis due to CF (HRCT showed that the above lung diseases became predominant) as judged by the Investigator. 4. Currently being treated Non-tuberculous Mycobacterial (NTM) pulmonary infections, allergic bronchopulmonary aspergillosis, or tuberculosis (TB), or active and currently symptomatic infections caused by COVID-19. 5. Patients who had experienced any degree of acute exacerbation of bronchiectasis or were developing an acute exacerbation of bronchiectasis before 4 weeks of screening. 6. Patients who had hemoptysis and required medical intervention within 4 weeks prior to screening(except for coughing up minorbloody streaks). 7. Have an abnormal renal function test result (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73m^2) at Screening. 8. Subjects with a history of liver disease or current treatment for liver disease during the screening period, including but not limited to acute or chronic hepatitis, cirrhosis or liver failure, or aspartate aminotransferase (AST) > 2.0×ULN or alanine aminotransferase (ALT) > 2.0×ULN or total bilirubin (TBIL) > 1.5×ULN. 9. Active hepatitis B virus infection (hepatitis B surface antigen positive with HBV-DNA load above the lower limit of detection), active hepatitis C virus infection (HCV antibody positive with HCV-RNA load above the lower limit of detection), or known HIV infection or syphilis infection. 10. Any other unstable clinical condition, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic, psychiatric, or major physiological dysfunction, that the investigator considers to be (a) likely to affect patient safety throughout the study; (b) Influence the results of the study and its interpretation; (c) impeding the patient's ability to complete the entire study. 11. Had participated in a clinical trial of any other drug or medical device in the 3 months prior to the screening (a drug or medical device treated with a clinical trial) or the subject had not been more than 5 half-lives from the last clinical trial of the drug at the time of screening. 12. Medications that may cause hyperkeratosis (e.g., tumor necrosis factor-α antagonists) within 4 weeks prior to screening. 13. Patients who have used a strong inducer or suppressor of CYP3A within 14 days or 5 half-lives of the first investigational drug (whichever is longer). 14. Patients who had smoked an average of 10 cigarettes or more per day in the previous 1 year were screened. 15. Pregnancy and lactation. 16. The subjects were unable to complete the questionnaires due to their limited educational level, or the subjects and their families failed to fill in the subjects' log cards. 17. Had received live attenuated vaccine within 30 days before randomization. 18. The investigators judged that there were other conditions that were not suitable for participation in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Liu
Phone
18782948571
Email
liuyanlc@haisco.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanping Mao
Phone
13818841887
Email
maoyanping@haisco.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nanshan Zhong
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weijie Guan
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weijie Guan
Email
battery203@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11986413
Citation
Barker AF. Bronchiectasis. N Engl J Med. 2002 May 2;346(18):1383-93. doi: 10.1056/NEJMra012519. No abstract available.
Results Reference
background
PubMed Identifier
29357265
Citation
Chalmers JD, Aliberti S, Filonenko A, Shteinberg M, Goeminne PC, Hill AT, Fardon TC, Obradovic D, Gerlinger C, Sotgiu G, Operschall E, Rutherford RM, Dimakou K, Polverino E, De Soyza A, McDonnell MJ. Characterization of the "Frequent Exacerbator Phenotype" in Bronchiectasis. Am J Respir Crit Care Med. 2018 Jun 1;197(11):1410-1420. doi: 10.1164/rccm.201711-2202OC.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/11986413/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/29357265/
Description
Related Info

Learn more about this trial

A Study of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis

We'll reach out to this number within 24 hrs