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RecruitingNCT06441812Updated Dec 18, 2025

A Study to Evaluate the Long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients

A Phase 2 interventional study of SHR-1703 Injection in Eosinophilic Asthma Patients, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.

Sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 2 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluation the long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients

02

Conditions studied

  • Eosinophilic Asthma Patients
03

In context

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd is the lead sponsor of 58 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. At least 18 years of age, Male or Femal.
  2. A minimum weight of 40kg.
  3. Subjects with the clinical features of asthma that meets the diagnostic criteria of the "Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 Edition)" and has a medical history of at least 1 year.
  4. Documentation of current asthma controller medication [medium or high dose ICS and at least one of additional controller such as long-acting muscarinic antagonist (LAMA), long-acting beta2-agonist (LABA) and leukotriene receptor antagonist (LTRA)] for at least 1 stable month before first administration of SHR-1703.
  5. At least one confirmed history of exacerbation within one year of initial administration of SHR-1703, occurring during the use of medium and high daily dose ICS.
  6. Absolute count of eosinophils must be ≥0.15×109/L at visit 0 and visit 1.
  7. A pre-bronchodilator FEV1 \<85% and ≥30% predicted at visit 0 and visit 1.
  8. Female subjects with fertility agree to have no plan pregnancy and voluntarily adopt high-efficiency contraception measures from signing the informed consent form to 14 months after the last dose of SHR-1703, and male subjects with fertility as partners agree to have no plan pregnancy and voluntarily adopt high-efficiency contraception measures between the first dose of SHR-1703 and the last visit in the study.
  9. Subjects must be able to give written informed consent prior to participation in the study.

Exclusion criteria

Exclusion Criteria:

  1. Presence of a clinically important lung condition. This includes but is not limited to current infection, bronchiectasis, pulmonary fibrosis or a history of lung cancer.
  2. A known immunodeficiency.
  3. Presence of a clinically significant and uncontrolled serious cardiovascular and cerebrovascular disease, including but not limited to myocardial infarction, unstable angina, heart failure, stroke, and subarachnoid haemorrhage.
  4. Within the first 4 weeks before visit 0, presence of exacerbation of allergic rhinitis or sinusitis, or a history of infections with clinical significance and/or requiring clinical intervention, including but not limited to respiratory infections.
  5. A known parasitic infection within the first 6 months before visit 0.
  6. A malignancy history within the first 5 years before visit 0 (Subjects that had localized basal carcinoma of the skin or cervical carcinoma in situ which was resected for cure will not be excluded).
  7. Blood donation or significant blood loss (≥ 400ml) within the first 4 weeks before visit 0, or infusion of blood products or immunoglobulins.
  8. Use systemic immunosuppressants (excluding systemic glucocorticoids used for asthma treatment and for non asthma treatment for less than 3 days) or immunomodulators, or biologics or Th2 cytokine inhibitors, including but not limited to methotrexate, cyclosporine, interferon-α, anti IL-5 monoclonal antibodies (including SHR-1703), anti IL-4R monoclonal antibodies, anti TSLP monoclonal antibodies, anti IgE monoclonal antibodies, metformin, etc., and within 5 half-lives of the drug before the first administration (refer to the longer drug instructions; for those with unknown half-lives, 12 weeks before the first administration shall prevail);
  9. Subjects who have previously participated in any study and received Investigational Product within the first 30 days before visit 0.
  10. There was a surgical plan or other treatment measures that the researcher believed may affect the subject's evaluation during the study period.
  11. Laboratory examination shows obvious abnormalities at visit 0 and visit 1:

    1. White blood cell count (WBC) \<3.0×109/L;
    2. Hemoglobin≤90g/L;
    3. Platelet\<100×109/L;
    4. Alanine aminotransferase (ALT)>2×ULN (upper limit of normal);
    5. Aspartate aminotransferase (AST) >2×ULN;
    6. Total bilirubin (TBIL)>1.5×ULN;
    7. Prothrombin time (PT) >ULN+3s;
    8. Creatinin>1.5×ULN;
    9. Active hepatitis B (positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) in peripheral blood), or positive for hepatitis C virus antibody, or positive for human immunodeficiency virus (HIV) antibody, or positive for treponema pallidum antibody;
  12. ECG QTc>450ms or other clinically significant abnormal results that may pose significant safety risks to the subjects at visit 0 or visit 1;
  13. A history of drug addicts or substance abuse within 1 years prior to Visit 0;
  14. Subjects who are pregnant (positive HCG test at visit 0 or visit 1) or breastfeeding should not be enrolled if they plan to become pregnant during the time of study participation;
  15. Subjects with a known allergy or intolerance to anti IL-5 monoclonal antibody or other biologic;
  16. Other reasons determined by the researcher as unsuitable for participation in the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    SHR-1703 Injection

    Drug: SHR-1703 Injection

Interventions

  • DrugSHR-1703 Injection

    SHR-1703 Injection

06

What researchers measure

Primary outcomes

  1. Adverse Events in main peroid,about 1 year

    Time frame: about 1 year

Secondary outcomes

  1. Absolute count of eosinophils , about 1 year

    Time frame: about 1 year

  2. Change of FEV1 、FEV1%pred、FVC、PEF,about 1 year.

    Time frame: about 1 year.

  3. Change of Fractional Exhaled Nitric Oxide (FeNO) ,about 1 year.

    Time frame: about 1 year.

  4. Questionnaire about asthma,about 1 year .

    Time frame: about 1 year .

  5. Frequency and time of asthma exacerbation , about 2 years

    Time frame: about 2 years

  6. Reduction in asthma controller , about 1 year

    Time frame: about 1 year

  7. Asthma remission, about 2 years

    Time frame: about 2 years

  8. Daily OCS use and reduction, about 1 year.

    Time frame: about 1 year.

07

Study locations

1 of 1 sites recruiting
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610041, China
    • Weimin Li · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06441812
Lead sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Jun 4, 2024
Start date
Jul 19, 2024
Primary completion
Sep 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Dec 18, 2025

Study contacts

Tianqi Zheng
Contact
tianqi.zheng.tz6@hengrui.com
+0518-81220121

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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