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This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of additional quilizumab therapy in adult patients with Chronic Spontaneous Urticaria resistant to antihistamine treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Quilizumab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Two administrations by subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Absolute change from baseline to Week 20 in the weekly itch score. | 21 weeks | |
| Safety: Incidence & severity of adverse events. | Approximately 30 weeks | |
| Safety: Incidence of anti-therapeutic antibodies. | Approximately 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Absolute change from baseline to Week 4 in the weekly itch score. | 5 weeks | |
| Efficacy: Absolute change from baseline to Week 20 in the UAS7 aggregate score. | 21 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto | Ontario | M4V 1R2 | Canada | |||
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| ID | Term |
|---|---|
| D014581 | Urticaria |
| ID | Term |
|---|---|
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
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| Quilizumab |
| Drug |
Two administrations by subcutaneous injection |
|
| Berlin |
| 10117 |
| Germany |
| Mainz | 55131 | Germany |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |