A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort A dose 1 |
Drug: SHR-1905
subcutaneous
|
| Experimental: Cohort B dose 2 |
Drug: SHR-1905
subcutaneous
|
| Experimental: Cohort C dose 3 |
Drug: SHR-1905
subcutaneous
|
| Placebo Comparator: Placebo
|
Drug: placebo
subcutaneous ,placebo
|
Outcome Measures
Primary Outcome Measures
- Efficacy：Annual asthma exacerbation rate (AAER) [From randomisation to 48 weeks]
Secondary Outcome Measures
- Changes from baseline in forced expiratory volume in one second (FEV1) [From randomisation to 72 weeks]
- Changes from baseline in forced vital capacity (FVC) [From randomisation to 72 weeks]
- Changes from baseline in peak expiratory flow (PEF) pre/post-bronchodilator (pre/ post-BD) [From randomisation to 72 weeks]
- Changes of fractional exhaled nitric oxide (FeNO) compared with baseline at each evaluation time [Baseline to72 weeks]
- Changes of blood eosinophils (EOS) compared with baseline at each evaluation time [Baseline to72 weeks]
- Changes of serum immunoglobulin E (IgE) compared with baseline at each evaluation time [Baseline to72 weeks]
- Changes from baseline in Asthma Control questionnaire (ACQ-6) scores [Baseline to 72 weeks]
- Changes from baseline in Asthmatic Quality of Life Questionnaire (AQLQ) scores [Baseline to 72 weeks]
- AAER associated with hospitalization at 48 weeks [From randomisation to 48 weeks]
- Changes from baseline in weekly mean daily Asthma Symptom Diary scores [Baseline to 72 weeks]
- The proportion of subjects with acute exacerbations of asthma [Baseline to 72 weeks]
- Changes from baseline in weekly reliever use [Baseline to 72 weeks]
- Changes from baseline in weekly mean morning and evening peak expiratory flow (PEF) [Baseline to 72 weeks]
- Changes from baseline in weekly mean number of night time awakenings [Baseline to 72 weeks]
- Time to the first acute asthma exacerbation [Baseline to 72 weeks]
- Changes of the Sino-Nasal Outcome Test-22-item (SNOT-22) score in patients with nasal polyps at each evaluation time [Baseline to 72 weeks]
- The proportion of subjects with composite endpoint for asthma (CompEx) [Baseline to72 weeks]
- Safety: Adverse events [Baseline to 72 weeks]
- Safety: Serious adverse events [Baseline to 72 weeks]
- Pharmacokinetics (PK): Serum concentration of SHR-1905 [72 weeks]
- Immunogenicity: The incidence of anti-drug antibody (ADA) [72 weeks]
- Immunogenicity: The timing of anti-drug antibody (ADA) [72 weeks]
- Immunogenicity: The duration of anti-drug antibody (ADA) [72 weeks]
- Immunogenicity: The titer of anti-drug antibody (ADA) [72 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female aged between 18 and 75 years (inclusive)
-
Weight ≥ 40 kg
-
Meet the diagnostic criteria for asthma and have a medical history of at least 1 year
-
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
-
At least one additional maintenance asthma controller with stable use for at least 3 months before randomization
-
No birth plan and must agree to take effective contraceptive methods
-
Sign informed consent form voluntarily for the trial
Exclusion Criteria:
-
Any clinically important pulmonary disease
-
Any disease other than asthma that may affect lung function
-
Any disease other than asthma related to elevation of eosinophils
-
Any immunodeficiency disease
-
Any clinically important serious cardiovascular diseases unstable or uncontrolled
-
Uncontrolled Hypertension
-
Uncontrolled Diabetes Mellitus
-
Any clinically important infections within 4 weeks before randomization
-
Any major surgery within 3 months before randomized, or any surgical plan during the study, or any treatment that the investigator think affect the evaluation of the subjects
-
Any parasitic infections within 6 months before randomization
-
Malignancy diagnosed within 5 years before randomization
-
Abnormal laboratory tests during screening and baseline
-
Positive infectious disease test
-
Prolonged QTc interval or other clinical significant abnormal findings in ECG at screening that may causesafety risk to the subject
-
Current smoker or smoking cessation for less than 6 months at screening, and/or positive nicotine test during screening，or smoking history ≥10 pack- years
-
Positive alcohol breath test and positive urine drug test at screening
-
Allergy history to any biological or other agent that investigator think the subject should not participate in the study
-
Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study
-
Participated in other clinical trials and used investigational drugs containing active ingredients within 4 weeks or 5 half-lives before screening
-
Any other circumstance judged by the investigatorinappropriate for participating in the clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China | 510163 |
Sponsors and Collaborators
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR-1905-201