A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma

Hengrui Medicine

Status and phase: Enrolling; Phase 3

Conditions: Asthma With Eosinophilic Phenotype

Treatments: Drug: HR-1703; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06653322

SHR-1703-302

Details and patient eligibility

About

The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype

Enrollment: 400 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. At least 12 years of age
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

1. With other condition that could lead to elevated eosinophils
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Subjects receiving SHR-1703 dose 1

Experimental group

Treatment:

Drug: HR-1703

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo