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Eosinophilic Asthma PatientsPhase 2NCT06441812

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

A Phase 2 study testing SHR-1703 Injection in people with Eosinophilic Asthma Patients, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Eosinophilic Asthma Patients
What is being tested?
SHR-1703 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
19 Jul 2024to Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age, Male or Femal.
  • A minimum weight of 40kg.
  • 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.
  • 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.
  • 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.
  • Absolute count of eosinophils must be ≥0.15×109/L at visit 0 and visit 1.
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  • A pre-bronchodilator FEV1 <85% and ≥30% predicted at visit 0 and visit 1.
  • 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.
  • Subjects must be able to give written informed consent prior to participation in the study.

Who cannot join

  • 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.
  • A known immunodeficiency.
  • 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.
  • 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.
  • A known parasitic infection within the first 6 months before visit 0.
  • 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).
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  • Blood donation or significant blood loss (≥ 400ml) within the first 4 weeks before visit 0, or infusion of blood products or immunoglobulins.
  • 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);
  • Subjects who have previously participated in any study and received Investigational Product within the first 30 days before visit 0.
  • There was a surgical plan or other treatment measures that the researcher believed may affect the subject's evaluation during the study period.
  • Laboratory examination shows obvious abnormalities at visit 0 and visit 1:
  • White blood cell count (WBC) <3.0×109/L;
  • Hemoglobin≤90g/L；
  • Platelet<100×109/L；
  • Alanine aminotransferase (ALT)>2×ULN (upper limit of normal);
  • Aspartate aminotransferase (AST) >2×ULN；
  • Total bilirubin (TBIL)>1.5×ULN;
  • Prothrombin time (PT) >ULN+3s；
  • Creatinin>1.5×ULN;
  • 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；
  • ECG QTc>450ms or other clinically significant abnormal results that may pose significant safety risks to the subjects at visit 0 or visit 1；
  • A history of drug addicts or substance abuse within 1 years prior to Visit 0；
  • 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；
  • Subjects with a known allergy or intolerance to anti IL-5 monoclonal antibody or other biologic；
  • Other reasons determined by the researcher as unsuitable for participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tianqi Zheng contact

+0518-81220121

tianqi.zheng.tz6@hengrui.com

China1 site, 1 recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Weimin Li

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Single-group Phase II Clinical Study to Evaluate the Long-term Safety, Pharmacodynamics and Efficacy of Multiple Subcutaneous Injections of SHR-1703 in Eosinophilic Asthma Patients

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

Being tested
SHR-1703 Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1703 InjectionDrug

    SHR-1703 Injection

Study groups in NCT06441812
Study groupRoleWhat they receive
SHR-1703 InjectionExperimentalNot described
Receives: Drug: SHR-1703 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events in main peroid，about 1 year

    Measured: about 1 year

Secondary outcomes (8)

  1. Absolute count of eosinophils , about 1 year

    Measured: about 1 year

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

    Measured: about 1 year.

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

    Measured: about 1 year.

  4. Questionnaire about asthma，about 1 year .

    Measured: about 1 year .

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

    Measured: about 2 years

  6. Reduction in asthma controller , about 1 year

    Measured: about 1 year

  7. Asthma remission, about 2 years

    Measured: about 2 years

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

    Measured: about 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2024
  2. Study start19 Jul 2024
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06441812
Sponsor's protocol ID
SHR-1703-202
Status last verified
Dec 2025
First submitted
29 May 2024
Last updated
18 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-1703 Injection in people with Eosinophilic Asthma Patients, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tianqi Zheng (+0518-81220121, tianqi.zheng.tz6@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events in main peroid，about 1 year (time frame: about 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06441812.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025; AzTrials last refreshed its copy on 2 Nov 2026.

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