Actively Recruiting
A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2025-12-10
400
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype
CONDITIONS
Official Title
A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 12 years of age
- Minimum weight of 40 kg
- Medical history of asthma for at least 1 year
- Current treatment with medium- or high-dose inhaled corticosteroids for at least 6 months and steady use for at least 3 months
- Current use of an additional asthma controller medication other than inhaled corticosteroids for at least 3 months and steady use for at least 1 month
- Blood eosinophil count indicating eosinophilic asthma
- Pre-bronchodilator FEV1 less than 80% during screening and baseline
- ACQ-6 score showing poor asthma control during screening and baseline
- History of severe asthma exacerbation within the past 12 months before screening
- Good compliance with electronic diary completion
- Use of effective contraceptive measures
- Voluntary signing of informed consent form
You will not qualify if you...
- Presence of other conditions causing elevated eosinophils
- Clinically significant pulmonary diseases
- Immunodeficiency diseases
- Other clinically significant diseases affecting lung function
- Uncontrolled severe cardiovascular or cerebrovascular diseases
- Uncontrolled hypertension and/or diabetes
- Exacerbation, allergic rhinitis or sinusitis attacks, or significant infection requiring treatment within 4 weeks before randomization
- Recent major surgeries or surgical plans during the study or treatments that may affect evaluation
- Existing parasitic infections
- Diagnosis of malignant tumor within 5 years before randomization
- Significant abnormalities in screening or baseline laboratory tests
- QTc prolongation on ECG during screening or baseline
- Use of prohibited drugs before randomization
- Participation in other clinical trials within 30 days before screening or within 5 half-lives of investigational drugs
- Smoking or quitting smoking less than 6 months before screening, or a smoking history of 10 or more pack-years
- History of drug use, alcoholism, or substance abuse within the past year before screening
- Allergy or intolerance to IL-5 monoclonal antibodies or other biological agents
- Pregnancy or lactation
- Other reasons deemed by researchers as unsuitable for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
West China School of Medicine West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
X
Xiaopeng Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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