Clinical trial NCT05593250: A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
Official title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study to Evaluate the Efficacy and Safety of SHR-1905 in Subjects With Severe Uncontrolled Asthma.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-10-25
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR-1905 compared with placebo
Primary purpose: TREATMENT

Brief summary: This study is a phase 2 study of SHR-1905 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of SHR-1905 in subjects with severe uncontrolled asthma.


Eligibility criteria: Inclusion Criteria:

1. Male or female aged between 18 and 75 years (inclusive)
2. Weight ≥ 40 kg
3. Meet the diagnostic criteria for asthma and have a medical history of at least 1 year
4. Treatment with a total daily dose of either medium or high dose inhaled glucocorticoids (ICS) for at least 6 months before screening, with a stable use for 3 months before randomization
5. At least one additional maintenance asthma controller with stable use for at least 3 months before randomization
6. At least 2 exacerbations within 12 months before screening
7. No birth plan and must agree to take effective contraceptive methods
8. Sign informed consent form voluntarily for the trial

Exclusion Criteria:

1. Any clinically important pulmonary disease
2. Any disease other than asthma that may affect lung function
3. Any disease other than asthma related to elevation of eosinophils
4. Any immunodeficiency disease
5. Any clinically important serious cardiovascular diseases unstable or uncontrolled
6. Uncontrolled Hypertension
7. Uncontrolled Diabetes Mellitus
8. Any clinically important infections within 4 weeks before randomization
9. Any major surgery within 3 months before randomized, or any surgical plan during the study, or any treatment that may affect the evaluation of the subjects considered by the investigator
10. Any parasitic infections within 6 months before randomization
11. Malignancy diagnosed within 5 years before randomization
12. Abnormal laboratory tests during screening and baseline
13. Positive infectious disease test
14. Prolonged QTc interval or other clinical significant abnormal findings in ECG at screening that may cause safety risk to the subject
15. Current smoker or smoking cessation for less than 6 months at screening, or smoking history ≥10 pack- years
16. Drug or alcohol abuse
17. Allergy history to any biologicsl or other agent that investigator think the subject should not participate in the study
18. Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study
19. Participated in other clinical trials and used investigational drugs containing active ingredients within 4 weeks or 5 half-lives before screening
20. Any other circumstance inappropriate for participating in the clinical trial considered by the investigator

Primary outcomes:
measure: Efficacy：Annual asthma exacerbation rate (AAER)
timeFrame: From randomisation to 48 weeks
Secondary outcomes:
measure: Changes of fractional exhaled nitric oxide (FeNO) compared with baseline
timeFrame: Baseline to72 weeks
measure: Changes from baseline in Asthma Control questionnaire (ACQ-6) scores
timeFrame: Baseline to 72 weeks
measure: Changes from baseline in Asthmatic Quality of Life Questionnaire (AQLQ) scores
timeFrame: Baseline to 72 weeks
measure: AAER associated with hospitalization at 48 weeks
timeFrame: From randomisation to 48 weeks
measure: Changes from baseline in Asthma Symptom Diary scores
timeFrame: Baseline to 72 weeks
measure: The proportion of subjects with acute exacerbations of asthma
timeFrame: Baseline to 72 weeks
measure: Changes from baseline in weekly reliever use
timeFrame: Baseline to 72 weeks
measure: Changes from baseline in weekly mean morning and evening peak expiratory flow (PEF)
timeFrame: Baseline to 72 weeks
measure: Changes from baseline in weekly mean number of night time awakenings
timeFrame: Baseline to 72 weeks
measure: Time to the first acute asthma exacerbation
timeFrame: Baseline to 72 weeks
measure: The proportion of subjects with composite endpoint for asthma (CompEx)
timeFrame: Baseline to72 weeks
measure: Pharmacokinetics (PK): Serum concentration of SHR-1905
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: