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

COMPLETEDPHASE2

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study to Evaluate the Pharmacodynamic, Efficacy and Safety of Multiple Subcutaneous Injections of SHR-1703 in Asthma Patients With Eosinophil Phenotype

NCT05522439•Jiangsu HengRui Medicine 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

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18 to 75years (inclusive).
•2. Weight ≥40 kg.
•3. History of asthma≥ 1 year.
•4. Documented treatment with Medium or high daily dose inhaled corticosteroid with additional controller medication within the 3 months prior to randomization.
•5. Previously confirmed history of one or more asthma exacerbations within 1 year prior to randomization.
•6. Blood eosinophils of ≥150 cells/µL at screening and baseline.
•7. Pre-Bronchodilator FEV1% pred≥40% and\<80% at screening and baseline.
•8. Asthma Control Questionnaire-6 score≥1.5.
•9. Use highly effective contraceptive measures.
•10. Willing to sign the informed consent form to participate in this study.

Exclusion Criteria

•1. Subjects with Clinically significant pulmonary diseases；
•2. Subjects with other diseases that could lead to elevated eosinophils；
•3. Subjects with Immunodeficiency；
•4. Poorly controlled hypertension;
•5. Subjects with severe cerebrovascular disease;
•6. Subjects with infection history requiring clinical intervention；
•7. Subjects with parasitic infection；
•8. Diagnosed Malignant tumor within 5 years prior to randomization;
•9. Used non-selective β-blockers within 1 week prior to randomization;
•10. Used either 5-lipoxygenase inhibitor or Phosphodiesterase-4 inhibitor within 1 week prior to randomization;
+14 more criteria

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

December 22, 2022

Primary Completion Date

September 12, 2024

Completion Date

September 12, 2024

Last Updated

May 28, 2025

Enrollment

ACTUAL participants

Conditions

Asthma With Eosinophilic Phenotype

Interventions

SHR-1703

DRUG

SHR-1703 Placebo

DRUG

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

NCT06653322

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: May 28, 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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