A Study to Assess the Efficacy and Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis

NCT06660992 | Recruiting Phase 3

• 1 other identifier: HSK31858-301
• Study Type: interventional
• Target: 669
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Non-cystic Fibrosis Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Frequency of pulmonary exacerbations

  week 52

Secondary Outcomes (4)

• Time to first pulmonary exacerbation

  week 52

• Change from Baseline(Screening) in forced expiratory volume in 1 second (FEV1)

  week 52

• Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score

  week 52

• Change from Baseline in the Respiratory Symptoms Domain Score of the Quality of Life (QOL) Bronchiectasis questionnaire

  week 52

Study Arms (2)

HSK31858 40mg

EXPERIMENTAL

HSK31858 40mg treat for 52-week

Drug: HSK31858, tablet

Placebo

PLACEBO COMPARATOR

the placebo comparator of study

Drug: Placebo

Interventions

HSK31858, tablet DRUG

HSK31858 is a novel inhibitor of DPP1 developed by Hisco Pharmaceutical and can reduce pulmonary exacerbations over a 52-week treatment period in patients with non-cystic fibrosis bronchiectasis

HSK31858 40mg

Placebo DRUG

the placebo comparator of study

Placebo

Eligibility Criteria

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

You may qualify if:

• \. 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.
• \. Have at least 2 pulmonary exacerbations in the past 12 months before Screening.
• \. 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.
• \. The estimated survival time ≥ 12 months. 6. 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.
• \. Males with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.
• \. Give their signed study informed consent to participate.

You may not qualify if:

• \. 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.
• \. Have bronchiectasis due to CF (HRCT showed that the above lung diseases became predominant) as judged by the Investigator.
• \. 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, or have the history of bronchopulmonary aspergillosis.
• \. Patients with severe pulmonary fibrosis such as lung destruction, pneumonectomy surgery history, and pneumoconiosis, as well as previous or existing decompensated stage of pulmonary heart disease.
• \. Patients who had experienced any degree of acute exacerbation of bronchiectasis or were developing an acute exacerbation of bronchiectasis before 4 weeks of screening.
• \. Patients who had hemoptysis and required medical intervention within 4 weeks prior to screening(except for coughing up minorbloody streaks).
• \. Patients previously treated with HSK31858 or other DPP1 inhibitor products. 9. Subjects with uncontrolled hypertension (SBP ≥180 mmHg at rest and/or DBP ≥110 mmHg). 10. Subjects with uncontrolled type 1 or type 2 diabetes (fasting plasma glucose \>7.0 mmol/L).
• \. 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 (except for mild to moderate non-alcoholic fatty liver disease).
• \. 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.
• \. 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.
• \. Laboratory tests during the screening period meet the following conditions:
• AST\>2.0×ULN or ALT\>2.0×ULN or TBIL\>1.5×ULN
• eGFR\<60ml/min/1.73m2
• Hb\<90 g/L
• WBC \<3×109 /L

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Yixing People's Hospital

Yixingcun, Jiangxi, China

RECRUITING

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Guan Wei Jie

CONTACT

86-13826042052; battery203@163.com

Study Design

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

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 28, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): November 28, 2026
• Study Completion (Estimated): January 27, 2027
• Last Updated: October 28, 2024

Record last verified: 2024-09

Locations

CN (2)