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

NCT07589439 | Recruiting Phase 2 DMC

• 1 other identifier: LQSW-LQ036-CN-IIb
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

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

  Baseline, Week 12

Secondary Outcomes (20)

• Percent Change From Baseline in Pre-bronchodilator FEV1 at Week 12

  Baseline, Week 12

• Absolute and Percent Change From Baseline in Pre-bronchodilator FEV1 at Weeks 1, 2, 4, 8, 16, 20, 24

  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

  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

  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

  Baseline, Weeks 12, 24

Other Outcomes (20)

• Safety Measures: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  From 2-week placebo run-in period up to Week 28

• Safety Measures: Incidence and Severity of Serious Adverse Events (SAEs)

  From Screening up to Week 28

• Safety Measures: Number of Participants With Abnormal Vital Signs of Potential Clinical Importance

  From Screening up to Week 28

Study Arms (3)

LQ036 12 mg

EXPERIMENTAL

LQ036 12 mg solution for nebulization, once daily for 24 weeks.

Biological: LQ036

LQ036 24 mg

EXPERIMENTAL

LQ036 24 mg solution for nebulization, once daily for 24 weeks.

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.

Biological: Placebo; Biological: LQ036

Interventions

Placebo BIOLOGICAL

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.

Placebo then Re-randomized to LQ036

LQ036 BIOLOGICAL

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.

LQ036 12 mg; LQ036 24 mg; Placebo then Re-randomized to LQ036

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Novamab Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Meng Huang

CONTACT

86+02120985259; mhuang@novamab.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 15, 2026
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

CN (1)