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This phase IIa trial is meant to evaluate the pharmacokinetics, pharmacodynamics and safety of JYB1904 in patients with allergic asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JYB1904: Dose-1 | Experimental |
| |
| JYB1904: Dose-2 | Experimental |
| |
| JYB1904: Dose-3 | Experimental |
| |
| Omalizumab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JYB1904 | Drug | Participants will receive JYB1904 every 8 weeks for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentrations of JYB1904 | Serum concentrations of JYB1904, assessed by pre-specified methods | Baseline through 337 days post-dose |
| Serum concentrations of IgE | Serum concentrations of IgE, assessed by pre-specified methods | Baseline through 337 days post-dose |
| Adverse Events(AEs) | Incidence and features of AEs assessed by CTCAE v5.0, and related safety parameters analysis | Baseline through 337 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Times of protocol-defined asthma exacerbations during the 24-week treatment period | Times of protocol-defined asthma exacerbations during the 24-week treatment period | Baseline through 168 days post-dose |
| Change in spirometry measures of forced expiratory volume in one second (FEV1) in 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Zhang | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 201203 | China |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Omalizumab | Drug | Participants will receive Omalizumab every 2/4 weeks for 24 weeks. |
|
forced expiratory volume in one second (FEV1) |
| Baseline through 24 weeks post-dose |
| Serum concentrations of anti-drug antibody (ADA) | Serum ADA assessed by pre-specified methods, and related immunogenic features analysis | Baseline through 337 days post-dose |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |