What is the goal of this study? The goal of this clinical trial is to find out whether the study drug LQ036 (a nebulized solution taken by inhaling through a nebulizer) works to improve lung function and asthma control in people whose asthma is not well controlled. The study will also learn about the safety of LQ036, how the body processes it, and whether the body develops an immune response to it.
What are the main questions?
The most important question is:
• Does LQ036 improve lung function (measured by FEV₁ - the amount of air you can blow out in one second) more than a placebo at Week 12?
Other important questions include:
* Does LQ036 improve lung function at other time points (weeks 1, 2, 4, 8, 16, 20, 24)? * Does LQ036 reduce asthma attacks (sudden worsening of asthma that needs extra treatment)? * Does LQ036 help people use less rescue medication (inhaler for quick relief) and have more days without asthma symptoms? * Does LQ036 improve scores on asthma control and quality of life questionnaires? * What medical problems do participants have when taking LQ036?
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.
Life-threatening asthma, defined as an asthma episode requiring intubation within 1 year prior to screening or during the run-in period, and/or a history of hypercapnia, respiratory arrest, hypoxic seizures, asthma-related syncopal episodes, etc.
Experienced a severe asthma exacerbation within 1 month prior to screening.
History of allergy to biologics, or known hypersensitivity to any component of the investigational product.
Use of biologics (including but not limited to anti-IgE, anti-IL-5, anti-IL-5 receptor, anti-IL-4/13 receptor, anti-TSLP monoclonal antibodies, etc.) and/or systemic immunosuppressants (including but not limited to methotrexate, cyclosporine, mycophenolate mofetil, tacrolimus, penicillamine, sulfasalazine, hydroxychloroquine, azathioprine, cyclophosphamide) for inflammatory diseases within 8 weeks or 5 half-lives (whichever is longer) prior to screening.
Parallel
Placebo
Biological/VaccinePlacebo is a look-alike solution for nebulization that contains no active drug. Participants will self-administer the placebo once daily by inhaling the nebulized solution.
LQ036
Biological/VaccineLQ036 is a single-domain antibody formulated as a solution for nebulization. Participants will self-administer the assigned dose once daily by inhaling the nebulized solution.
Absolute Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Percent Change From Baseline in Pre-bronchodilator FEV1 at Week 12
Absolute and Percent Change From Baseline in Pre-bronchodilator FEV1 at Weeks 1, 2, 4, 8, 16, 20, 24
Absolute and Percent Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) at Weeks 1, 2, 4, 8, 12, 16, 20, 24
Absolute and Percent Change From Baseline in Pre-bronchodilator FEV1% Predicted, Forced Vital Capacity (FVC), and Forced Expiratory Flow (FEF25%-75%) at Weeks 1, 2, 4, 8, 12, 16, 20, 24
Safety Measures: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug, regardless of causal relationship. TEAEs are defined as AEs that start or worsen on or after the first dose of study drug.
Safety Measures: Incidence and Severity of Serious Adverse Events (SAEs)
A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Safety Measures: Number of Participants With Abnormal Vital Signs of Potential Clinical Importance
Vital signs assessments include systolic blood pressure (mmHg), diastolic blood pressure (mmHg), respiratory rate (bmp), heart rate (bpm) and body temperature (℃). Clinically significant abnormalities are determined by the investigator based on pre-defined criteria or medical judgment.
Safety Measures: Number of Participants With Clinically Significant Findings on Physical Examination
Physical examination includes assessment of general appearance; skin; head, eyes, ears, nose and throat (HEENT); chest; abdomen; spine; extremities; nervous system; and lymph nodes. Clinically significant findings are determined by the investigator based on pre-defined criteria or medical judgment.
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