Clinical trial NCT06653322: A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma
Official title: A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Asthma With Eosinophilic Phenotype
Lead sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-10-22
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Annualised asthma exacerbation rate，about 48weeks
timeFrame: about 48weeks
Secondary outcomes:
measure: Mean number of days with oral corticosteroids taken for exacerbation，about 48weeks
timeFrame: about 48weeks
measure: Frequency of exacerbations requiring hospitalisation，about 48weeks
timeFrame: about 48weeks
measure: Time to first exacerbation requiring hospitalisation，about 48weeks
timeFrame: about 48weeks
measure: Mean change from baseline in clinic pre- and post-BD FEV1，about 64 weeks
timeFrame: about 64 weeks
measure: Mean change from baseline in clinic pre- and post-BD FEV1%，about 64weeks
timeFrame: about 64weeks
measure: Mean change from baseline in clinic pre- and post-BD FVC，about 64 weeks
timeFrame: about 64 weeks
measure: Mean change from baseline in clinic pre- and post-BD PEF，about 64 weeks
timeFrame: about 64 weeks
measure: Mean change from baseline in FeNO，about 64weeks
timeFrame: about 64weeks
measure: Mean change from baseline in asthma control questionnaire (ACQ-6) score，about 64 weeks
timeFrame: about 64 weeks
measure: Mean change from baseline in ASTHMA QUALITY OF LIFE QUESTIONNAIRES (AQLQ) score，about 64weeks
timeFrame: about 64weeks
measure: Mean change from baseline in Asthma symptom score at week 12/24/36/48/60，about 64weeks
timeFrame: at week 12/24/36/48/60，about 64weeks
measure: Mean change from baseline in daily rescue medication use at week 12/24/36/48/60，about 64weeks
timeFrame: at week 12/24/36/48/60，about 64weeks
measure: Mean change from baseline in awakening at night due to asthma symptoms requiring rescue medication use at week 12/24/36/48/60，about 64weeks
timeFrame: at week 12/24/36/48/60，about 64weeks
measure: Mean change from baseline in morning and evening PEF at week 12/24/36/48/60，about 64weeks
timeFrame: at week 12/24/36/48/60，about 64weeks
measure: Mean change from baseline in IgE，about 64weeks
timeFrame: about 64weeks
measure: Adverse events，about 64weeks
timeFrame: about 64weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China School of Medicine West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: