AsthmaPhase 2NCT07589439
Dose-Ranging Study of LQ036 Single-Domain Antibody Nebulization Solution in Poorly Controlled Asthma
A Phase 2 study testing LQ036 in people with Asthma, run by Shanghai Novamab Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- LQ036
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2025to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 2 years prior to screening is acceptable.
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- At screening, blood eosinophil (EOS) count ≥150 cells/μL or 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.
- 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.
Who cannot join
- 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.
- Received intravenous immunoglobulin (IVIG) or allergen-specific immunotherapy (SIT) within 3 months prior to screening.
- Received systemic corticosteroids (excluding topical, ophthalmic, or intranasal corticosteroids), antibiotics, antifungals, antivirals, antiparasitic drugs, non-selective beta-blockers, or herbal medicines with anti-asthmatic effects within 1 month prior to screening or during the run-in period.
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- Received live or attenuated vaccine within 3 months prior to screening, or plan to receive live or attenuated vaccine during the study period.
- Underwent bronchial thermoplasty within 12 months prior to screening.
- Underwent major surgery within 8 weeks prior to screening, or plans to undergo surgery requiring general anesthesia or hospitalization for >1 day during the study period.
- In the investigator's judgment, presence of respiratory diseases other than asthma, including but not limited to chronic obstructive pulmonary disease (COPD), asthma-COPD overlap syndrome (ACOS), or any other significant lung disease (e.g., active pneumonia, idiopathic pulmonary fibrosis, pneumothorax, atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, bronchiectasis, etc.), that may place the participant at undue risk or affect the evaluation of study results.
- Based on imaging and investigator judgment, presence of active tuberculosis or non-tuberculous mycobacterial infection, untreated latent tuberculosis, or history of incompletely treated tuberculosis.
- Active autoimmune disease or autoimmune disease requiring immunosuppressive therapy, such as rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.
- Blood EOS >1500 cells/μL at screening, or other systemic diseases that may cause elevated peripheral blood EOS count (e.g., hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, eosinophilic esophagitis, etc.), which in the investigator's judgment may affect the evaluation of the drug.
- Known or suspected immunodeficiency, including history of invasive opportunistic infection (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) even if resolved; or presence of unusually frequent, recurrent, or prolonged infections suggestive of an immunocompromised state.
- Known parasitic infection, or suspected or high-risk parasitic infection in the investigator's judgment.
- Active infection (e.g., upper respiratory tract infection) within 1 month prior to screening or during the run-in period, or acute infection requiring systemic anti-infective therapy.
- History of lymphoproliferative disease or malignancy (participants with basal cell carcinoma, localized squamous cell carcinoma of the skin, or cervical carcinoma in situ are eligible if they have completed curative treatment and have had no evidence of recurrence for at least 12 months prior to signing informed consent), or other medical history that in the investigator's judgment may affect the evaluation of the drug.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Jieming Qu, Principal Investigator, +86-21-64370045 ext. 680801, Jmqu0906@163.com
Wei Tang, Principal Investigator, +86-21-64370045 ext. 680801, Tw10986@rjh.com.cn
About this study
Official title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of LQ036 Single-Domain Antibody Nebulization Solution in Patients With Poorly Controlled Asthma
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?
Read more
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?
Read the detailed description
The study includes four periods: a screening period of up to 2 weeks to check eligibility, followed by a 2 week run in period during which all participants take a placebo once daily by nebulizer and record symptoms and rescue medication use. Participants are then randomly assigned to one of three groups for the 24 week treatment period: LQ036 12 mg, LQ036 24 mg, or placebo once daily. For the first 12 weeks, the LQ036 groups are compared with the placebo group; after 12 weeks, those originally on placebo are reassigned to either LQ036 12 mg or 24 mg for the remaining 12 weeks. Throughout the study period, all participants continue their usual asthma controller medicines. A 4 week safety follow up visit occurs after the 24 week treatment to monitor for side effects.
- Conditions
- Asthma
- Being tested
- Placebo, LQ036
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Placebo 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.
LQ036Biological
LQ036 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.
| Study group | Role | What they receive |
|---|---|---|
| LQ036 12 mg | Experimental | LQ036 12 mg solution for nebulization, once daily for 24 weeks. Receives: Biological: LQ036 |
| LQ036 24 mg | Experimental | LQ036 24 mg solution for nebulization, once daily for 24 weeks. Receives: Biological: LQ036 |
| Placebo then Re-randomized to LQ036 | Placebo comparator | Placebo solution for nebulization once daily for 12 weeks, followed by re-randomization (1:1) to either LQ036 12 mg or LQ036 24 mg solution for nebulization once daily for an additional 12 weeks. Receives: Biological: Placebo; Biological: LQ036 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Measured: Baseline, Week 12
Secondary outcomes (20)
Percent Change From Baseline in Pre-bronchodilator FEV1 at Week 12
Measured: Baseline, Week 12
Absolute and Percent Change From Baseline in Pre-bronchodilator FEV1 at Weeks 1, 2, 4, 8, 16, 20, 24
Measured: Baseline, 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
Measured: Baseline, 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
Measured: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Absolute and Percent Change From Baseline in Post-bronchodilator FEV1 at Weeks 12 and 24
Measured: Baseline, Weeks 12, 24
Annualized Rate of Composite Exacerbation (CompEx) Events During the Treatment Period
Measured: Baseline up to Week 24
Time to First Composite Exacerbation (CompEx) Event
Measured: Baseline up to Week 24
Annualized Rate of Loss of Asthma Control (LOAC) Events During the Treatment Period
Measured: Baseline up to Week 24
Time to First Loss of Asthma Control (LOAC) Event
Measured: Baseline up to Week 24
Annualized Rate of Severe Exacerbation (SevEx) Events During the Treatment Period (in participants with history of severe exacerbation in past 12 months)
Measured: Baseline up to Week 24
Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During the Treatment Period (in participants with history of severe exacerbation in past 12 months)
Measured: Baseline up to Week 24
Time to First Severe Exacerbation (SevEx) Event (in participants with history of severe exacerbation in past 12 months)
Measured: Baseline up to Week 28
Time to First Severe Exacerbation Event Resulting in Hospitalization or Emergency Room Visit (in participants with history of severe exacerbation in past 12 months)
Measured: Baseline up to Week 28
Absolute Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Weeks 1, 2, 4, 8, 12, 16, 20, 24
The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranging from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
Measured: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Absolute Change From Baseline in Nighttime Asthma Symptom Scores at Weeks 1, 2, 4, 8, 12, 16, 20, 24
Nighttime asthma symptom score was determined using an AM (ante meridiem) symptom scoring system, which evaluated the participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as follows:
0 = No symptoms;
- = Symptoms caused one nocturnal awakening (or early awakening);
- = Symptoms caused two or more nocturnal awakenings (including early awakening);
- = Symptoms caused the participant to be awake for most of the night;
- = Symptoms were severe and the participant could not fall asleep at night. Higher scores indicate more severe asthma symptoms. A negative change from baseline represents improvement.
Measured: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Absolute Change From Baseline in Daytime Asthma Symptom Scores at Weeks 1, 2, 4, 8, 12, 16, 20, 24
Daytime asthma symptom score was determined using a PM (post meridiem) symptom scoring system, which evaluated the participant's overall asthma symptoms experienced during the day. It ranged from 0 to 5 as follows:
0 = No symptoms;
- = Only one short episode of symptoms;
- = Two or more short episodes of symptoms;
- = Symptoms present most of the time, but did not interfere with daily activities;
- = Symptoms present most of the time and interfered with daily activities;
- = Symptoms were severe, unable to work or perform daily activities as usual. Higher scores indicate more severe asthma symptoms. A negative change from baseline represents improvement.
Measured: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Absolute Change From Baseline in Average Daily Reliever Medication Use (puffs/day) at Weeks 1, 2, 4, 8, 12, 16, 20, 24
Measured: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Number of Reliever Medication-Free Days During the Treatment Period
Measured: Baseline up to Week 24
Absolute Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Global Score at Weeks 12 and 24
The Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ[S]) is a 32 item disease specific instrument measuring the functional impairments that are most important to adults with asthma. Each item is scored on a 7 point Likert scale where 1 = maximal impairment and 7 = no impairment. The global score is the mean of all 32 responses, ranging from 1 (severely impaired quality of life) to 7 (not impaired at all). Higher scores indicate better quality of life. A positive change from baseline indicates improvement.
Measured: Baseline, Weeks 12, 24
Absolute and Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Each Time Point
Measured: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start30 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment for 12 weeks (1:1:1), followed by re-randomization of placebo participants to LQ036 12 mg or 24 mg for weeks 13-24.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Novamab Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589439
- Sponsor's protocol ID
- LQSW-LQ036-CN-IIb
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of LQ036 Single-Domain Antibody Nebulization Solution in Patients With Poorly Controlled Asthma
- ClinicalTrials.gov ID
- NCT07589439
- Acronym / sponsor ID
- LQSW-LQ036-CN-IIb
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Shanghai Novamab Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
The study includes four periods: a screening period of up to 2 weeks to check eligibility, followed by a 2 week run in period during which all participants take a placebo once daily by nebulizer and record symptoms and rescue medication use. Participants are then randomly assigned to one of three groups for the 24 week treatment period: LQ036 12 mg, LQ036 24 mg, or placebo once daily. For the first 12 weeks, the LQ036 groups are compared with the placebo group; after 12 weeks, those originally on placebo are reassigned to either LQ036 12 mg or 24 mg for the remaining 12 weeks. Throughout the study period, all participants continue their usual asthma controller medicines. A 4 week safety follow up visit occurs after the 24 week treatment to monitor for side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel assignment for 12 weeks (1:1:1), followed by re-randomization of placebo participants to LQ036 12 mg or 24 mg for weeks 13-24.
| Arm | Type | Receives |
|---|---|---|
| LQ036 12 mg | Experimental | Biological: LQ036LQ036 12 mg solution for nebulization, once daily for 24 weeks. |
| LQ036 24 mg | Experimental | Biological: LQ036LQ036 24 mg solution for nebulization, once daily for 24 weeks. |
| Placebo then Re-randomized to LQ036 | Placebo comparator | Biological: Placebo, Biological: LQ036Placebo solution for nebulization once daily for 12 weeks, followed by re-randomization (1:1) to either LQ036 12 mg or LQ036 24 mg solution for nebulization once daily for an additional 12 weeks. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
- Received intravenous immunoglobulin (IVIG) or allergen-specific immunotherapy (SIT) within 3 months prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo 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. | Biological | Placebo then Re-randomized to LQ036 |
| LQ036LQ036 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. | Biological | LQ036 12 mg, LQ036 24 mg, Placebo then Re-randomized to LQ036 |
Primary outcome
Absolute Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Time frame: Baseline, Week 12
20 secondary outcomes
Percent Change From Baseline in Pre-bronchodilator FEV1 at Week 12
Time frame: Baseline, Week 12
Absolute and Percent Change From Baseline in Pre-bronchodilator FEV1 at Weeks 1, 2, 4, 8, 16, 20, 24
Time frame: Baseline, 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
Time frame: Baseline, 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
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Absolute and Percent Change From Baseline in Post-bronchodilator FEV1 at Weeks 12 and 24
Time frame: Baseline, Weeks 12, 24
Annualized Rate of Composite Exacerbation (CompEx) Events During the Treatment Period
Time frame: Baseline up to Week 24
Time to First Composite Exacerbation (CompEx) Event
Time frame: Baseline up to Week 24
Annualized Rate of Loss of Asthma Control (LOAC) Events During the Treatment Period
Time frame: Baseline up to Week 24
Time to First Loss of Asthma Control (LOAC) Event
Time frame: Baseline up to Week 24
Annualized Rate of Severe Exacerbation (SevEx) Events During the Treatment Period (in participants with history of severe exacerbation in past 12 months)
Time frame: Baseline up to Week 24
Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During the Treatment Period (in participants with history of severe exacerbation in past 12 months)
Time frame: Baseline up to Week 24
Time to First Severe Exacerbation (SevEx) Event (in participants with history of severe exacerbation in past 12 months)
Time frame: Baseline up to Week 28
Time to First Severe Exacerbation Event Resulting in Hospitalization or Emergency Room Visit (in participants with history of severe exacerbation in past 12 months)
Time frame: Baseline up to Week 28
Absolute Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Weeks 1, 2, 4, 8, 12, 16, 20, 24
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Absolute Change From Baseline in Nighttime Asthma Symptom Scores at Weeks 1, 2, 4, 8, 12, 16, 20, 24
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Absolute Change From Baseline in Daytime Asthma Symptom Scores at Weeks 1, 2, 4, 8, 12, 16, 20, 24
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Absolute Change From Baseline in Average Daily Reliever Medication Use (puffs/day) at Weeks 1, 2, 4, 8, 12, 16, 20, 24
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Number of Reliever Medication-Free Days During the Treatment Period
Time frame: Baseline up to Week 24
Absolute Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Global Score at Weeks 12 and 24
Time frame: Baseline, Weeks 12, 24
Absolute and Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Each Time Point
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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RecruitingPhase 3
A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
Asthma
Not yet recruitingPhase 4
Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LQ036 in people with Asthma, run by Shanghai Novamab Biopharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng Huang (86+02120985259, mhuang@novamab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.