RecruitingPhase 3NCT06653322
A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma
Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Enrollment
400 participants
Start Date
Nov 21, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype
Eligibility
Min Age: 12 Years
Inclusion Criteria12
- 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 Criteria19
- 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
Interventions
DRUGHR-1703
HR-1703 will be administered by SC injection.
DRUGPlacebo
Matching Placebo will be administered by the SC injection.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06653322