RecruitingPhase 3NCT06653322

A Multi-centered,Randomized,Double-blind,Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma


Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Enrollment

400 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called SHR-1703 for people with eosinophilic asthma — a type of asthma driven by high levels of a white blood cell called eosinophils — that is not well controlled despite being on multiple inhaler medicines. **You may be eligible if...** - You are 12 or older and weigh at least 40 kg (about 88 lbs) - You have had asthma for at least 1 year - You are on medium or high-dose inhaled corticosteroids (ICS) plus at least one other controller medication - Your blood eosinophil count is elevated (consistent with eosinophilic asthma) - Your asthma is poorly controlled and you had at least one severe flare-up in the past year - Your lung function testing (FEV1) shows reduced airflow **You may NOT be eligible if...** - Your asthma is well-controlled on current medications - Your eosinophil count is not elevated - You are pregnant or breastfeeding - You have certain other serious lung or immune 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

DRUGHR-1703

HR-1703 will be administered by SC injection.

DRUGPlacebo

Matching Placebo will be administered by the SC injection.


Locations(1)

West China School of Medicine West China Hospital of Sichuan University

Chengdu, Sichuan, China

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NCT06653322