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The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.
The total duration of study per patient is approximately 66 weeks, including 6 weeks of screening period, 52 weeks of treatment period and 8 weeks of follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 610 group | Experimental | Subjects will receive 610 for 52 weeks. |
|
| placebo group | Placebo Comparator | Subjects will receive placebo for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 610 | Drug | 610 subcutaneously injection. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized rate of severe exacerbation events | Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first severe exacerbation event | Time to first severe exacerbation event during the 52-week placebo-controlled treatment period | Up to 52 weeks |
| Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qinghong Zhou, MD | Contact | +86 18911301578 | zhouqinghong@3sbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Min Zhang | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Xin Zhou | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Drug |
Placebo subcutaneously injection. |
|
Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit during the 52-week placebo-controlled treatment period |
| Up to 52 weeks |
| Change from baseline in ACQ score | Change from baseline to week 52 in ACQ score | Up to 52 weeks |
| Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ) | Change from baseline to week 52 in SGRQ score | Up to 52 weeks |
| Change in pre-bronchodilator forced expiratory volume (FEV1) | Absolute change from baseline to week 52 in pre-bronchodilator FEV1 | Up to 52 weeks |
| Assessment of adverse events (AEs) | Number of participants with adverse events (AEs) | Up to 60 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |