A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma
NCT ID: NCT06653322
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2024-11-21
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Subjects receiving SHR-1703 dose 1
HR-1703
HR-1703 will be administered by SC injection.
Placebo
Placebo
Matching Placebo will be administered by the SC injection.
Interventions
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HR-1703
HR-1703 will be administered by SC injection.
Placebo
Matching Placebo will be administered by the SC injection.
Eligibility Criteria
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Inclusion Criteria
2. A minimum weight of 40kg
3. A medical history of at least 1 year that meets the diagnosis of asthma;
4. Current treatment with medium- or high- doses of ICS for at least 6 months and using steadily at least 3 months
5. Current treatment with an additional controller medication, besides ICS, for at least 3 months and using steadily at least 1 month
6. Absolute count of blood eosinophils suggests eosinophilic asthma
7. During the screening period and baseline, pre- BD FEV1% \< 80%
8. During the screening period and baseline, ACQ-6 score indicates asthma poor control
9. History of severe asthma exacerbation within the past 12 months prior to screening
10. Good compliance with eDiary completion
11. Take efficient contraceptive measures
12. Voluntarily sign the informed consent form to participate in this study
Exclusion Criteria
2. With Clinically significant pulmonary diseases
3. With existing immunodeficiency disease
4. With other clinically significant diseases that may affect lung function
5. With uncontrolled severe cardiovascular and cerebrovascular diseases
6. With uncontrolled hypertension and/or diabetes
7. With exacerbation, allergic rhinitis or sinusitis attacks, or clinical significant infection requiring intervention during 4 weeks prior to randomization
8. Recent major surgeries or surgical plans during the study period, or treatment measures that investigators believe may affect subject evaluation
9. Existing parasitic infections
10. Diagnosed as malignant tumor within the first 5 years of randomization
11. Significant abnormalities in screening period or baseline laboratory tests
12. Screening period or baseline ECG QTc prolongation
13. Prohibited drugs using during the pre randomization period
14. 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
15. Smoking or quitting smoking for less than 6 months during screening, or previous smoking history ≥ 10 pack years
16. History of drug use, alcoholism, or substance abuse within the past year prior to screening
17. Allergic or intolerant to IL-5 monoclonal antibodies or other biological agents
18. Pregnant or lactating subjects
19. Other reasons why the researcher deemed it unsuitable for conducting this experiment
12 Years
ALL
No
Sponsors
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Guangdong Hengrui Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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West China School of Medicine West China Hospital of Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Other Identifiers
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SHR-1703-302
Identifier Type: -
Identifier Source: org_study_id