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

August 7, 2026 updated by: Guangdong Hengrui Pharmaceutical Co., Ltd
The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
401

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China School of Medicine West China Hospital of Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  11. Take efficient contraceptive measures
  12. Voluntarily sign the informed consent form to participate in this study

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
  11. Significant abnormalities in screening period or baseline laboratory tests
  12. Screening period or baseline ECG QTc prolongation
  13. Prohibited drugs using during the pre randomization period
  14. Participated in other clinical trials within 30 days prior to screening and used research drugs containing active ingredients, or was still within 5 half lives of the research drug at the time of screening
  15. Smoking or quitting smoking for less than 6 months during screening, or previous smoking history ≥ 10 pack years
  16. History of drug use, alcoholism, or substance abuse within the past year prior to screening
  17. Allergic or intolerant to IL-5 monoclonal antibodies or other biological agents
  18. Pregnant or lactating subjects
  19. Other reasons why the researcher deemed it unsuitable for conducting this experiment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Matching Placebo will be administered by the SC injection.
Experimental: Subjects receiving SHR-1703 dose 1
Drug: HR-1703
HR-1703 will be administered by SC injection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Annualised asthma exacerbation rate，about 48weeks
Time Frame: about 48weeks
about 48weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mean number of days with oral corticosteroids taken for exacerbation，about 48weeks
Time Frame: about 48weeks
about 48weeks
Frequency of exacerbations requiring hospitalisation，about 48weeks
Time Frame: about 48weeks
about 48weeks
Time to first exacerbation requiring hospitalisation，about 48weeks
Time Frame: about 48weeks
about 48weeks
Mean change from baseline in clinic pre- and post-BD FEV1，about 64 weeks
Time Frame: about 64 weeks
about 64 weeks
Mean change from baseline in clinic pre- and post-BD FEV1%，about 64weeks
Time Frame: about 64weeks
about 64weeks
Mean change from baseline in clinic pre- and post-BD FVC，about 64 weeks
Time Frame: about 64 weeks
about 64 weeks
Mean change from baseline in clinic pre- and post-BD PEF，about 64 weeks
Time Frame: about 64 weeks
about 64 weeks
Mean change from baseline in FeNO，about 64weeks
Time Frame: about 64weeks
about 64weeks
Mean change from baseline in asthma control questionnaire (ACQ-6) score，about 64 weeks
Time Frame: about 64 weeks
about 64 weeks
Mean change from baseline in ASTHMA QUALITY OF LIFE QUESTIONNAIRES (AQLQ) score，about 64weeks
Time Frame: about 64weeks
about 64weeks
Mean change from baseline in Asthma symptom score at week 12/24/36/48/60，about 64weeks
Time Frame: at week 12/24/36/48/60，about 64weeks
at week 12/24/36/48/60，about 64weeks
Mean change from baseline in daily rescue medication use at week 12/24/36/48/60，about 64weeks
Time Frame: at week 12/24/36/48/60，about 64weeks
at week 12/24/36/48/60，about 64weeks
Mean change from baseline in awakening at night due to asthma symptoms requiring rescue medication use at week 12/24/36/48/60，about 64weeks
Time Frame: at week 12/24/36/48/60，about 64weeks
at week 12/24/36/48/60，about 64weeks
Mean change from baseline in morning and evening PEF at week 12/24/36/48/60，about 64weeks
Time Frame: at week 12/24/36/48/60，about 64weeks
at week 12/24/36/48/60，about 64weeks
Mean change from baseline in IgE，about 64weeks
Time Frame: about 64weeks
about 64weeks
Adverse events，about 64weeks
Time Frame: about 64weeks
about 64weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHR-1703-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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