Chronic Spontaneous Urticaria
Conditions
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamine at the time of randomization * Chronic spontaneous urticaria diagnosis for 6 months
Exclusion criteria
Exclusion criteria: * Weight less than 20 kg * Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria * Evidence of parasitic infection * Any other skin diseases than chronic spontaneous urticaria with chronic itching * Previous treatment with omalizumab * Contraindications to diphenhydramine * History of anaphylactic shock * History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study * History of hypersensitivity to omalizumab or to drugs of similar chemical classes * Pregnant or nursing (lactating) women Other protocol defined inclusion/exclusion may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline to Week 12 in the Weekly Itch Severity Score [Time Frame: Baseline to Week 12] The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7) [Time Frame: Baseline to Week 12] The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. A negative change score indicates improvement. Change From Baseline to Week 12 in the Weekly Number of Hives Score [Time Frame: Baseline to Week 12] The weekly hives score is the sum of the daily hives scores over 7days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement. | — |
Outcome results
None listed