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

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

A Study to Evaluate the Long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients (NCT06441812) is a Phase 2 interventional studying Eosinophilic Asthma Patients, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Eosinophilic Asthma Patients and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 200 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Eosinophilic Asthma Patients subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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 willing to sign a consent form prior to participation in the study. Who Should NOT Join This Trial: 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 weakened immune system. 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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: 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.

Treatments Being Tested

DRUG

SHR-1703 Injection

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

West China Hospital of Sichuan University

Chengdu, Sichuan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06441812), the sponsor (Guangdong Hengrui Pharmaceutical Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06441812 clinical trial studying?

The purpose of this study is to evaluation the long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06441812?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06441812?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06441812. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06441812. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.