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Study to determine the efficacy of benralizumab when compared to placebo in patients with chronic hives that do not respond to antihistamine treatment
Subjects with chronic hives that do not respond to antihistamine treatment and have hives of unknown cause will be eligible. Subjects who meet the inclusion/exclusion criteria after the run-in phase will receive 3 doses of study medication. The study also involved blood draws and a punch biopsy of a hive
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo for benralizumab sc given during run-in phase |
|
| benralizumab | Experimental | benralizumab sc once a month for 3 months for subjects who meet inclusion/exclusion criteria after run-in phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| benralizumab | Biological | open-label treatment |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| change in urticarial activity score averaged over 7 days- no units | subject completed form | through study completion, up to 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in blood anti-FCER1 level (kU/l) | specific lab test | through study completion, up to 7 months |
| change in blood anti-TPO level (IU/L) | specific blood test |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | adverse events | through study completion, up to 7 months |
| change in blood pressure | blood pressure- mm Hg | through study completion, up to 7 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45231 | United States |
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| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C571386 | benralizumab |
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single-blind
| Biological |
sterile water to mimic benralizumab |
|
| through study completion, up to 7 months |
| change in Blood ECP level (ug/L) | specific blood test | through study completion, up to 7 months |
| change in blood eotaxin level (pg/ml) | specific blood test | through study completion, up to 7 months |
| change in RNA testing | gene expression profile using RNA-sequencing in skin biopsy samples (lesional vs non-lesional skin) (log 2 fold-change) | through study completion, up to 7 months |
| change in skin biopsy inflammatory cell counts | inflammatory cell count in skin biopsy (number of cells/sq mm) | through study completion, up to 7 months |
| change in cytokine quantification in skin biopsy (units/mL) | skin biopsy | through study completion, up to 7 months |
| change in pulse rate | pulse rate- bpm | through study completion, up to 7 months |
| change in blood urea nitrogen | blood urea nitrogen lab test - mg/dl | through study completion, up to 7 months |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |