A Phase IIb Trial of LQ036 in Poorly Controlled Asthma

Inclusion Criteria

• •Outpatients, aged 12 to 75 years inclusive, male or female, with body mass index (BMI) between 18 and 30 kg/m² inclusive. For participants aged 12 to 17 years, body weight must be ≥30 kg.
• •Diagnosed with bronchial asthma according to the 2025 Global Initiative for Asthma (GINA) guidelines prior to screening, with a documented history of asthma for ≥12 months.
• •For at least 3 months prior to screening, the participant has used inhaled corticosteroids (ICS) combined with at least one controller medication, and has maintained a stable treatment regimen and dosage for at least 1 month prior to screening. Low, medium, and high maintenance doses of ICS are defined according to the 2025 GINA guidelines (if multiple nebulized or combined administration methods are used, doses are to be combined).
• •At screening, pre-bronchodilator FEV₁ is ≥40% and \<80% of the predicted normal value. For participants on low-dose ICS, pre-bronchodilator FEV₁ is ≥40% and \<85% of the predicted normal value.
• •At screening, Asthma Control Questionnaire-5 (ACQ-5) score ≥1.5.
• •At screening, a positive bronchodilator reversibility test (increase in FEV₁ of ≥12% and an absolute increase of ≥200 mL, 15-30 minutes after inhalation of 400 μg salbutamol). If the reversibility test does not reach the positive threshold, one additional test is permitted within 7 days (excluding the day of the initial test). Alternatively, documented evidence of a positive bronchodilator reversibility test within 12 months prior to screening is acceptable.
• •At screening, blood eosinophil (EOS) count ≥150 cells/μL and fractional exhaled nitric oxide (FeNO) ≥25 ppb.
• •Experienced ≥1 severe exacerbation within the 12 months prior to screening (not required for participants on low-dose ICS).
• •Participants fully understand the purpose, nature, methods, and possible adverse reactions of the study, voluntarily agree to participate, and sign the informed consent form before any study procedures begin.
• •At randomization, pre-bronchodilator FEV₁ has increased by ≤20% from the screening value, and remains ≥40% and \<80% of the predicted normal value (for participants on low-dose ICS, pre-bronchodilator FEV₁ is ≥40% and \<85% of the predicted normal value).
• •At randomization, ACQ-5 score ≥1.5.
• •At randomization, blood EOS count ≥150 cells/μL and FeNO ≥25 ppb.
• •During the run-in period, participant compliance with run-in medication and background medication is ≥80% and ≤120%, compliance with daily diary completion is ≥80%, and there are complete data for at least 4 days within the 7 days prior to randomization.
• •Presence of any other severe and/or uncontrolled disease or treatment that, in the investigator's judgment, may affect the evaluation of the drug, including but not limited to: severe neurological disease, severe mental disorder, uncontrolled diabetes mellitus, uncontrolled hypertension, major cardiovascular disease, corrected QT interval prolongation (male \>450 ms, female \>470 ms, Fridericia's formula), or persistent arrhythmia.
• •Current smoker or cessation of smoking for \<6 months; or former smoker with a smoking history of ≥10 pack-years (pack-years = \[cigarettes per day / 20\] × years of smoking).
• •Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody at screening (participants with positive HBsAg but HBV-DNA below the lower limit of detection, or positive HCV antibody but HCV-RNA below the lower limit of detection, are eligible).
• •Participants with severe liver or kidney dysfunction, such as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 × upper limit of normal (ULN), or serum creatinine \>1.5 × ULN.
• •Pregnant or breastfeeding women; women planning to become pregnant during the study or within 3 months after the end of the study; fertile women or men who, in the investigator's judgment, cannot use medically accepted reliable contraception from signing informed consent until 3 months after the last dose of study drug; positive pregnancy test result at screening or before randomization for fertile women.
• •Participation in another clinical study of a drug or device within 3 months prior to signing informed consent, with use of investigational drug/device; or still within the follow-up period of another clinical study or within 5 half-lives of the investigational drug (whichever is longer) at the time of signing informed consent.
• •History of blood donation or significant blood loss, blood transfusion, or use of blood products within 3 months prior to screening.
• •Known or suspected non-compliance, drug abuse, substance abuse, or alcohol abuse (daily pure alcohol intake \>40 g for males, \>20 g for females).
• •Any condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical trial.