Actively Recruiting
A Study to Evaluate the Long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2025-12-18
200
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluation the long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients
CONDITIONS
Official Title
A Study to Evaluate the Long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age, male or female
- Minimum weight of 40 kg
- Clinical diagnosis of asthma per 2020 guidelines with at least 1 year history
- Stable use of medium or high dose inhaled corticosteroids plus at least one additional asthma controller medication for at least 1 month before first SHR-1703 dose
- At least one confirmed asthma exacerbation within one year prior to SHR-1703 first administration while on medium or high dose inhaled corticosteroids
- Absolute eosinophil count of at least 0.15 x10^9/L at visit 0 and visit 1
- Pre-bronchodilator FEV1 less than 85% and at least 30% predicted at visit 0 and visit 1
- Female participants of childbearing potential agree to use effective contraception from consent to 14 months after last SHR-1703 dose; male participants agree to contraception from first dose to last visit
- Ability to provide written informed consent
You will not qualify if you...
- Presence of significant lung conditions such as infection, bronchiectasis, pulmonary fibrosis, or history of lung cancer
- Known immunodeficiency
- Significant uncontrolled cardiovascular or cerebrovascular disease including myocardial infarction, unstable angina, heart failure, stroke, or subarachnoid hemorrhage
- Exacerbation of allergic rhinitis or sinusitis, or significant infection requiring intervention within 4 weeks before visit 0
- Known parasitic infection within 6 months before visit 0
- History of malignancy within 5 years before visit 0 (except localized basal cell carcinoma or cervical carcinoma in situ)
- Blood donation or significant blood loss (≥400 ml) within 4 weeks before visit 0, or receipt of blood products or immunoglobulins
- Use of systemic immunosuppressants, immunomodulators, biologics, or Th2 cytokine inhibitors within 5 half-lives before first administration (excluding certain glucocorticoids)
- Participation in another investigational study with investigational product within 30 days before visit 0
- Planned surgery or treatments that could affect study evaluations
- Abnormal laboratory values at visits 0 and 1 including low white blood cells, hemoglobin, platelets; elevated liver enzymes or bilirubin; prolonged prothrombin time; elevated creatinine; positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- QTc interval over 450 ms or other clinically significant ECG abnormalities
- History of drug addiction or substance abuse within 1 year prior to visit 0
- Pregnancy or breastfeeding, or plans to become pregnant during study
- Known allergy or intolerance to anti-IL-5 monoclonal antibodies or other biologics
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
T
Tianqi Zheng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here