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

May 27, 2025 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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.
Completed

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.
85

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 2

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 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;
  11. Blood donation or massive blood loss, or transfusion of blood products or immunoglobulins within 4 weeks prior to randomization;
  12. Live attenuated vaccine inoculated within 4 weeks before randomization;
  13. Allergen Immunotherapy within 8 weeks prior to randomization；
  14. Used systemic immunosuppressants or immunomodulators, or biologics or Th2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug;
  15. Bronchial thermoplasty within 1 year prior to randomization；
  16. Subjects have planned Surgery or other medical procedures that may affect evaluation during the study period;
  17. Subjects with significant laboratory abnormality at screening；
  18. Subjects have prolonged QTc interval or other electrocardiogram abnormality with significant safety risk at screening;
  19. Current smokers or ex-smokers who have given up smoking for <6 months ，or positive smoke test, and/or have a smoking pack history of > 10 pack years;
  20. History of drug or substance abuse or alcohol abuse within 1 year prior to screening;
  21. Subjects participated another clinical studies and received active drug within 30 days or 5 half-lives prior to screening;
  22. Subjects is pregnant, lactating,or planning to become pregnant;
  23. Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents;
  24. Other conditions unsuitable for participation in the study per investigator judgement.

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: SHR-1703 Placebo
Matching Placebo will be administered by the SC route.
Experimental: Subjects receiving SHR-1703 dose 1
Drug: SHR-1703
SHR-1703 will be administered by SC injection.
Drug: SHR-1703 Placebo
Matching Placebo will be administered by the SC route.
Experimental: Subjects receiving SHR-1703 dose 2
Drug: SHR-1703
SHR-1703 will be administered by SC injection.
Experimental: Subjects receiving SHR-1703 dose 3
Drug: SHR-1703
SHR-1703 will be administered by SC injection.
Drug: SHR-1703 Placebo
Matching Placebo will be administered by the SC route.

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
Changes from baseline in Blood Eosinophils
Time Frame: Up to Week 52
Up to Week 52

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
Changes from baseline in Pre- and post-Bronchodilator FEV1
Time Frame: Up to Week 52
Up to Week 52
Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred
Time Frame: Up to Week 52
Up to Week 52
Changes from baseline in Pre- and post-Bronchodilator FVC
Time Frame: Up to Week 52
Up to Week 52
Changes from baseline in Pre- and post-Bronchodilator PEF
Time Frame: Up to Week 52
Up to Week 52
Changes from baseline in n fractional exhaled nitric oxide (FeNO)
Time Frame: Up to Week 52
Up to Week 52
Changes from baseline in Asthma Control Questionnaire-6(ACQ-6)
Time Frame: Up to Week 52
Up to Week 52
Changes from baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ)
Time Frame: Up to Week 52
Up to Week 52
Frequency of use of asthma relievers
Time Frame: Up to Week 24
Up to Week 24
Frequency of exacerbations of asthma
Time Frame: Up to Week 24
Up to Week 24
Frequency of severe exacerbations of asthma
Time Frame: Up to Week 24
Up to Week 24
Time to first exacerbation of asthma
Time Frame: Up to Week 24
Up to Week 24
Time to first severe exacerbation of asthma
Time Frame: Up to Week 24
Up to Week 24

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.
Jiangsu HengRui Medicine 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.
December 22, 2022

Primary Completion (Actual)

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 12, 2024

Study Completion (Actual)

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.
September 12, 2024

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).
August 29, 2022

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.
August 29, 2022

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.
August 31, 2022

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.
May 28, 2025

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.
May 27, 2025

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.
May 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-1703-201

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

product manufactured in and exported from the U.S.

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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