RecruitingPhase 3NCT06323213

Efficacy and Safety Study of 610 in Patients With Severe Asthma

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 610 in Chinese Adult Subjects With Severe Eosinophilic Asthma


Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Enrollment

480 participants

Start Date

Jun 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an investigational drug called "610" in adults with severe asthma that is not well controlled with current treatments. The goal is to evaluate whether this new medication can reduce asthma symptoms and improve lung function safely. **You may be eligible if:** - You are between 18 and 75 years old - You have been diagnosed with asthma for at least one year - Your asthma is classified as severe and requires inhaled corticosteroids plus at least one other controller medication - Your asthma has been managed with these medications for at least 6 months **You may NOT be eligible if:** - You have another significant lung condition besides asthma - You had a severe asthma attack (exacerbation) within the 4 weeks before the study starts - You have other eosinophilic conditions (conditions where a type of white blood cell called eosinophils is elevated for a different reason) - You have serious cardiovascular disease - You have other significant concurrent medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG610

610 subcutaneously injection.

DRUGPlacebo

Placebo subcutaneously injection.


Locations(1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

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NCT06323213


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