This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
218
Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
Change From Baseline in the Weekly Itch Severity Score at Week 12
The weekly itch severity score is a component of the Urticaria Activity Score 7 (UAS7) composite score. The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. 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 from baseline indicates improvement.
Time frame: Baseline to Week 12
Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12
The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria 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 urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement.
Time frame: Baseline to Week 12
Change From Baseline in the Weekly Number of Hives Score at Week 12
The weekly hives score is the sum of the daily hives scores over 7 days 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.
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Novartis Investigative Site
Toyoake, Aichi-ken, Japan
Novartis Investigative Site
Hiroshima, Hiroshima, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan
Novartis Investigative Site
Nishinomiya, Hyōgo, Japan
Novartis Investigative Site
Hitachi, Ibaraki, Japan
Novartis Investigative Site
Takamatsu, Kagawa-ken, Japan
Novartis Investigative Site
Kawasaki, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
...and 29 more locations
Time frame: Baseline to Week 12
Percentage of Participants With a UAS7 Score ≤ 6 at Week 12
The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria 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 urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms.
Time frame: Week 12
Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12
The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (\> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score from baseline indicates a reduction in hive size.
Time frame: Baseline to Week 12
Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12
Weekly itch severity score MID response is defined as a reduction from baseline in weekly itch severity score of ≥ 5 points.
Time frame: Week 12
Percentage of Complete Responders (UAS7 = 0) at Week 12
Complete responders are defined as participants who achieved UAS7 = 0.
Time frame: Week 12
Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12
The DLQI is a 10-item dermatology-specific health-related quality of life measure. Participants rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score from baseline indicates improvement.
Time frame: Baseline to Week 12
Percentage of Participants With Production of Anti-omalizumab Antibody
Serum samples were collected for anti-omalizumab antibody testing.
Time frame: Week 24