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

RECRUITINGPHASE3

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

NCT06653322•Guangdong Hengrui Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. At least 12 years of age
•2. A minimum weight of 40kg
•3. A medical history of at least 1 year that meets the diagnosis of asthma;
•4. Current treatment with medium- or high- doses of ICS for at least 6 months and using steadily at least 3 months
•5. Current treatment with an additional controller medication, besides ICS, for at least 3 months and using steadily at least 1 month
•6. Absolute count of blood eosinophils suggests eosinophilic asthma
•7. During the screening period and baseline, pre- BD FEV1% \< 80%
•8. During the screening period and baseline, ACQ-6 score indicates asthma poor control
•9. History of severe asthma exacerbation within the past 12 months prior to screening
•10. Good compliance with eDiary completion
+2 more criteria

Exclusion Criteria

•1. With other condition that could lead to elevated eosinophils
•2. With Clinically significant pulmonary diseases
•3. With existing immunodeficiency disease
•4. With other clinically significant diseases that may affect lung function
•5. With uncontrolled severe cardiovascular and cerebrovascular diseases
•6. With uncontrolled hypertension and/or diabetes
•7. With exacerbation, allergic rhinitis or sinusitis attacks, or clinical significant infection requiring intervention during 4 weeks prior to randomization
•8. Recent major surgeries or surgical plans during the study period, or treatment measures that investigators believe may affect subject evaluation
•9. Existing parasitic infections
•10. Diagnosed as malignant tumor within the first 5 years of randomization
+9 more criteria

Locations (1)

West China School of Medicine West China Hospital of Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

November 21, 2024

Primary Completion Date

September 1, 2027

Completion Date

December 1, 2027

Last Updated

December 10, 2025

Enrollment

400

ESTIMATED participants

Conditions

Asthma With Eosinophilic Phenotype

Interventions

HR-1703

DRUG

Placebo

DRUG

Contacts

Xiaopeng Wang

CONTACT

+086-18260387118 xiaopeng.wang@hengrui.com

A Study to Evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients With Eosinophil Phenotype

NCT05522439

Asthma With Eosinophilic Phenotype

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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