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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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

Dose-Ranging Study of LQ036 Single-Domain Antibody Nebulization Solution in Poorly Controlled Asthma (NCT07589439) is a Phase 2 interventional studying Asthma, sponsored by Shanghai Novamab Biopharmaceuticals Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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?

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Asthma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 216 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Asthma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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. Exclusion Criteria: * 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. * 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.

Treatments Being Tested

BIOLOGICAL

Placebo

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.

BIOLOGICAL

LQ036

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07589439), the sponsor (Shanghai Novamab Biopharmaceuticals Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07589439 clinical trial studying?

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 1… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07589439?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07589439?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07589439. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07589439. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.