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The study was withdrawn due to an internal decision.
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This multi-center, single-arm study is designed to evaluate clinical experience of participants (or caregivers) administering lebrikizumab at home in participants with asthma. Eligible participants will receive four doses of subcutaneous (SC) lebrikizumab every 4 weeks (q4w) up to Week 12. Primary analysis visit occurs at Week 13. After study treatment, all participants will complete a 12 week safety follow up. All participants will get training for the administartion of lebrikizumab using the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lebrikizumab | Experimental | Participants will receive lebrikizumab SC using prefilled syringes (PFS), q4w up to Week 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lebrikizumab | Drug | Lebrikizumab will be administered SC using PFS, q4w up to Week 12. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with adherence to each planned home administration | up to Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who reported device complaints | up to Week 13 | |
| Serum lebrikizumab concentration at Weeks 13 and 24 | Week 13 and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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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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| ID | Term |
|---|---|
| C561806 | lebrikizumab |
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| Prefilled Syringes |
| Device |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |