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

NCT07589439 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2026-05-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Shanghai Novamab Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07589439 on ClinicalTrials.gov