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
• 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.