A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD

Official title

A Randomized, Double-blind, Single-dummy, Positive Drug and Placebo-controlled, Parallel Group, Multicenter, Phase 2a Study to Evaluate the Efficacy and Safety of Hemay005 in Adult Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease

Overview

A Multicenter, Randomized, Double-blind, Single-dummy, positive drug and placebo-controlled, Parallel Group, Phase 2a Study to Evaluate the Efficacy and Safety of Hemay005 in Adults with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).

Detailed description

This is a phase 2a, multicenter, randomized, double-blind, single-dummy, positive drug and placebo-controlled, parallel group study to evaluate the safety and efficacy of Hemay005 in adults with moderate to severe chronic obstructive pulmonary disease (COPD). Subjects will receive Hemay005 twice daily, or placebo, or positive drug roflumilast with a maximum treatment duration of 12 weeks. The study also includes an off-treatment safety follow-up period of 4 weeks.

Interventions

• Drug Hemay005 tablets
  Subjects take Hemay005 tablets for 12 weeks.
• Drug Roflumilast Oral Tablet
  Subjects take roflumilast tablet for 12 weeks.
• Drug Placebo tablet
  Subjects take placebo tablet for 12 weeks.

Primary outcome measures

• Sputum biomarkers [Time frame: Change from baseline to week 4]
• Sputum cell count [Time frame: Change from baseline to week 4]
• Blood Biomarkers [Time frame: Change from baseline to week 4]

Secondary outcome measures (3)

• Sputum biomarkers [Time frame: Change from baseline to week 12]
• Sputum cell count [Time frame: Change from baseline to week 12]
• Blood Biomarkers [Time frame: Change from baseline to week 12]

Eligibility criteria

Inclusion criteria

• Age at least 40 years old at the time of signing the informed consent form, both gender;
• Subjects with an established diagnosis of COPD (according to GOLD 2025) at least 12 months before the screening visit, with chronic bronchitis (defined as productive cough for at least 3 months in each of the prior two consecutive years) and/or with chronic productive cough at least 12 months prior to screening;
• Confirmed diagnosis of chronic obstructive pulmonary disease at the screening visit, FEV1 (forced expiratory volume in 1 second)/FVC (forced vital capacity) ratio<70% after albuterol use, and FEV1 after albuterol use>30% predicted of normal value and equal or smalled than 70% predicted value at the screening visit;
• Subjects on regular maintenance therapy: inhaled glucocorticoids (ICS), LAMA, or LABA, or any combination thereof. Received maintenance therapy for at least 6 months prior to screening; Maintenance therapy must not change the dosage of these drugs from 28 days before signing the informed consent form until the end of the trial (16 weeks or safety visit after early withdrawal).
• At least one of the following effective contraceptive methods should be adopted for female patients with fertility and male patients who have not undergone vasectomy during the entire study period from the date of signing the informed consent to 3 months after the last dose. Acceptable contraceptive methods in this study include: a. abstinence; b. hormones (oral intake, patch, ring, injection, implantation) combined with male condoms. This measure must be applied at least 30 days prior to the first administration of investigational drug, otherwise another acceptable method of contraception must be used; c. intra-uterine device (IUD) combined with male condoms; d. barrier method (diaphragm, cervical cap, sponge) combined with male condoms; exceptional circumstances: a) females who have been menopausal for 5 years and more, and b) surgical sterilization (proof should be provided).
• Subjects voluntarily participate in this clinical trial and sign the informed consent form.

Exclusion criteria

• Subjects with a prior history of asthma or concurrent diagnosis of asthma, with or without active disease, are excluded.
• Subjects with a moderate or severe COPD exacerbation i.e. resulting in the use of systemic corticosteroids (oral/IV/IM corticosteroids) and/or antibiotics or need for hospitalisation or a lower respiratory tract infection 6 weeks prior to screening.
• Diseases that in the opinion of the investigator may interfere with clinical assessments, such as bronchiectasis, sarcoidosis, cystic fibrosis, pulmonary hypertension, interstitial lung disease, bronchiolitis, pneumonectomy, lung cancer, congestive heart failure, diffuse bronchiolitis, silicosis, etc.
• COPD with emphysema phenotype according to the investigator's judgment and/or medical history records (emphysema phenotype is defined as alveolar destruction leading to permanent airway obstruction, in addition to cough and sputum, subjects usually have severe symptoms of dyspnea, shortness of breath, etc.); or have alpha1-antitrypsin deficiency.
• Patients with chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) and hepatitis B core antibody (HBcAb) should be assessed for all patients during screening: patients with positive hepatitis B surface antigen (HBsAg) will be excluded; patients with HBsAg (negative), HBsAb (negative or positive) and HBcAb (positive) should be tested for HBV-DNA, and if the HBV-DNA result is positive, patient will be excluded; if the HBV-DNA result is negative, patients can be enrolled in the study.), chronic hepatitis C virus (HCV) infection (patients with positive hepatitis C virus antibody (HCVAb) excluded) or human immunodeficiency virus (HIV) infection (patients with positive human immunodeficiency virus (HIV) antibody excluded) or Syphilis (TP) infection (excluded patients with Treponema pallidum antibody (Anti-TP) positive).
• . The investigator judged that the patient had other conditions that were not suitable for entry into this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 2 centers

• Tianjin Fourth Central Hospital — Tianjin
• China People's Armed Police Force Characteristic Medical Center — Tianjin

Identifiers

NCT: NCT07314242 · HM005COPD2S01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗