Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients

Phase 3

Completed

Conditions: Chronic Spontaneous Uriticaria

Interventions: Other: Placebo
Biological: Omalizumab

Registration Number: NCT02329223

Lead Sponsor: Novartis Pharmaceuticals

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 218

Inclusion Criteria

Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamine at the time of randomization
Chronic spontaneous urticaria diagnosis for 6 months

Key

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
Omalizumab 300 mg	Omalizumab	Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
Omalizumab 150 mg	Omalizumab	Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Weekly Itch Severity Score at Week 12	Baseline to 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12	Baseline to 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.
Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12	Baseline to 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.
Change From Baseline in the Weekly Number of Hives Score at Week 12	Baseline to 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.
Percentage of Participants With Production of Anti-omalizumab Antibody	Week 24	Serum samples were collected for anti-omalizumab antibody testing.
Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12	Week 12	Weekly itch severity score MID response is defined as a reduction from baseline in weekly itch severity score of ≥ 5 points.
Percentage of Complete Responders (UAS7 = 0) at Week 12	Week 12	Complete responders are defined as participants who achieved UAS7 = 0.
Percentage of Participants With a UAS7 Score ≤ 6 at Week 12	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.
Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12	Baseline to 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.