RecruitingPhase 3NCT07098403

A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase Ⅲ Study to Evaluate the Efficacy and Safety of SHR-1905 in Subjects With Severe Uncontrolled Asthma


Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Enrollment

408 participants

Start Date

Sep 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a phase III study of SHR-1905 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of SHR-1905 in subjects with severe uncontrolled asthma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new biologic drug called SHR-1905 for adults with severe asthma that is not controlled despite already taking medium-to-high doses of inhaled steroids plus at least one other controller medication. Researchers want to see if SHR-1905 reduces asthma attacks and improves breathing. **You may be eligible if...** - You are 18 or older - You have had a confirmed asthma diagnosis for at least 12 months - You have been on medium-to-high dose inhaled steroids for at least 6 months plus another asthma controller medication - You have had at least 2 asthma attacks requiring treatment in the past year - Your breathing test (FEV1) is below 80% of what's expected - Your asthma control questionnaire score is 1.5 or higher **You may NOT be eligible if...** - You have another significant lung disease (besides asthma) - You have had cancer - You smoke or have a significant smoking history (10+ pack-years) - You have hepatitis B, C, or HIV - You are pregnant or breastfeeding - You have had a severe allergic reaction to a biologic drug 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

DRUGSHR-1905 Injection

SHR-1905 injection.

DRUGSHR-1905 Placebo Injection

SHR-1905 placebo Injection.


Locations(1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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NCT07098403


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