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NCT Number: NCT06653322

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

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

Recruiting

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

West China School of Medicine West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location status: Recruiting

Location contact

Weimin Li

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 12 years of age
  • A minimum weight of 40kg
  • A medical history of at least 1 year that meets the diagnosis of asthma;
  • Current treatment with medium- or high- doses of ICS for at least 6 months and using steadily at least 3 months
  • Current treatment with an additional controller medication, besides ICS, for at least 3 months and using steadily at least 1 month
  • Absolute count of blood eosinophils suggests eosinophilic asthma
  • During the screening period and baseline, pre- BD FEV1% < 80%
  • During the screening period and baseline, ACQ-6 score indicates asthma poor control
  • History of severe asthma exacerbation within the past 12 months prior to screening
  • Good compliance with eDiary completion
  • Take efficient contraceptive measures
  • Voluntarily sign the informed consent form to participate in this study

Exclusion criteria

  • With other condition that could lead to elevated eosinophils
  • With Clinically significant pulmonary diseases
  • With existing immunodeficiency disease
  • With other clinically significant diseases that may affect lung function
  • With uncontrolled severe cardiovascular and cerebrovascular diseases
  • With uncontrolled hypertension and/or diabetes
  • With exacerbation, allergic rhinitis or sinusitis attacks, or clinical significant infection requiring intervention during 4 weeks prior to randomization
  • Recent major surgeries or surgical plans during the study period, or treatment measures that investigators believe may affect subject evaluation
  • Existing parasitic infections
  • Diagnosed as malignant tumor within the first 5 years of randomization
  • Significant abnormalities in screening period or baseline laboratory tests
  • Screening period or baseline ECG QTc prolongation
  • Prohibited drugs using during the pre randomization period
  • 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
  • Smoking or quitting smoking for less than 6 months during screening, or previous smoking history ≥ 10 pack years
  • History of drug use, alcoholism, or substance abuse within the past year prior to screening
  • Allergic or intolerant to IL-5 monoclonal antibodies or other biological agents
  • Pregnant or lactating subjects
  • Other reasons why the researcher deemed it unsuitable for conducting this experiment

Treatment and study plan

HR-1703

Drug

HR-1703 will be administered by SC injection.

Placebo

Drug

Matching Placebo will be administered by the SC injection.

Primary outcomes

  1. Annualised asthma exacerbation rate,about 48weeks

    Time frame: about 48weeks

Secondary outcomes

  1. Mean number of days with oral corticosteroids taken for exacerbation,about 48weeks

    Time frame: about 48weeks

  2. Frequency of exacerbations requiring hospitalisation,about 48weeks

    Time frame: about 48weeks

  3. Time to first exacerbation requiring hospitalisation,about 48weeks

    Time frame: about 48weeks

  4. Mean change from baseline in clinic pre- and post-BD FEV1,about 64 weeks

    Time frame: about 64 weeks

  5. Mean change from baseline in clinic pre- and post-BD FEV1%,about 64weeks

    Time frame: about 64weeks

  6. Mean change from baseline in clinic pre- and post-BD FVC,about 64 weeks

    Time frame: about 64 weeks

  7. Mean change from baseline in clinic pre- and post-BD PEF,about 64 weeks

    Time frame: about 64 weeks

  8. Mean change from baseline in FeNO,about 64weeks

    Time frame: about 64weeks

  9. Mean change from baseline in asthma control questionnaire (ACQ-6) score,about 64 weeks

    Time frame: about 64 weeks

  10. Mean change from baseline in ASTHMA QUALITY OF LIFE QUESTIONNAIRES (AQLQ) score,about 64weeks

    Time frame: about 64weeks

  11. 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

  12. 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

  13. 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

  14. 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

  15. Mean change from baseline in IgE,about 64weeks

    Time frame: about 64weeks

  16. Adverse events,about 64weeks

    Time frame: about 64weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaopeng Wang

CONTACT

[email protected]

+086-18260387118

Sponsors and collaborators

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Industry

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 22, 2024
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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