RecruitingPhase 2

Dose-Ranging Study of LQ036 Single-Domain Antibody Nebulization Solution in Poorly Controlled Asthma

China216 participantsStarted 2025-09-30

Plain-language summary

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?

Who can participate

Age range

12 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 tes…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1LQ036 is a single-domain antibody given by nebulization — how does that delivery method compare to the inhalers or biologics I might already be using, and would switching to a nebulized treatment fit into my daily routine?
2Since this is a Phase 2 dose-ranging trial, the researchers are still figuring out the right dose — what does that mean for what's currently known about the safety and effectiveness of LQ036 in people with asthma like mine?
3The trial is measuring how much my lung function (FEV1) improves over 12 weeks — is that a long enough window to tell whether this treatment is actually helping someone with my level of poorly controlled asthma?
4Before considering this trial, are there standard approved treatments for poorly controlled asthma — like existing biologics or step-up therapies — that I haven't tried yet and that might be a better first step for me?
5What would happen to my current asthma medications if I joined this trial — would I need to stop or reduce anything I rely on to keep my symptoms under control?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Absolute Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12

Timeframe: Baseline, Week 12

Trial details

NCT IDNCT07589439

SponsorShanghai Novamab Biopharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Meng Huang

86+02120985259 mhuang@novamab.com

View on ClinicalTrials.gov More Asthma trials