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

NCT06441812 | Recruiting Phase 2

• 1 other identifier: SHR-1703-202
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Eosinophilic Asthma Patients

Outcome Measures

Primary Outcomes (1)

• Adverse Events in main peroid，about 1 year

  about 1 year

Secondary Outcomes (8)

• Absolute count of eosinophils , about 1 year

  about 1 year

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

  about 1 year.

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

  about 1 year.

• Questionnaire about asthma，about 1 year .

  about 1 year .

• Frequency and time of asthma exacerbation , about 2 years

  about 2 years

Study Arms (1)

SHR-1703 Injection

EXPERIMENTAL

Drug: SHR-1703 Injection

Interventions

SHR-1703 Injection DRUG

SHR-1703 Injection

SHR-1703 Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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);

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Central Study Contacts

Tianqi Zheng

CONTACT

+0518-81220121; tianqi.zheng.tz6@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: July 19, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

CN (1)