Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment

Study Overview
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Brief Summary
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Evaluate the proportion of patients with an urticaria control test [UCT] score of greater than or equal to 12 at Week 12.

Official Title
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A Phase IV, Multicenter, Single-arm and Open-label Study With Omalizumab (Xolair®) in Chronic Spontaneous Urticaria (CSU) Patients Who Remain Symptomatic Despite Antihistamine (H1) Treatment

Conditions
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CHRONIC SPONTANEOUS URTICARIA

Intervention / Treatment
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* Drug: OMALIZUMAB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged between 18 and 75 years. Diagnosis of CSU for ≥ 6 months and an inadequate response to nsH1 antihistamines at the time of the request, as defined by the following: The presence of itch and hives for > 6 consecutive weeks at any time prior to enrollment, despite current use of H1 antihistamine therapy during this time period. Weekly UAS7 score (range 0 to 42) 16 and UCT score (range 0 to 16) < 8 prior to enrollment (Day 1) Current use of an H1 antihistamine for CSU on the day of the initial visit and Day Informed consent Exclusion Criteria: Treatment with an investigational agent within 30 days before enrollment. Routine (daily or every other day during 5 or more consecutive days) doses of the following medications within 30 days prior to Day -7: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide. Intravenous (i.v.) immunoglobulin G or plasmapheresis within 30 days prior to Day -7 Regular (daily/every other day) doxepin (oral) use within 14 days prior to Day -7. Any H2 antihistamine use within 7 days prior to Day -7. Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to Day 7. Concomitant use of cyclosporine or any other immunosuppressive agent. Hypersensitivity to omalizumab or any component of the formulation. History of anaphylactic shock.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMALIZUMAB<br>sub cutaneous injections of 300 mg every 4 weeks until Week 8. | Drug: OMALIZUMAB<br>* sub cutaneous injections of 300 mg every 4 weeks until Week 8.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12 | Number of participants with an Urticaria Control Test score of greater than or equal to 12 at Week 12 The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. | WEEK 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema | 2 patients with angioedema status were missing at baseline and not included | WEEK 12 | 
| CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema | A total score of UAS7 is calculated by adding for 7 days the daily UAS. The UAS7 is the sum of the daily UAS over 7 days before baseline and W12. The UAS7 score ranges from 0 to 42 with higher scores reflecting higher activity of the disease. Scores were categorized into five diseases states : urticaria-free (score =0), well-controlled (scores 1-6), mild (scores 7-15), moderate (scores 16-27) and severe urticaria (scores 28-42). | baseline and week 12 | 
| Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12 | The UCT is a questionnaire collecting retrospective information over the last 4 weeks before baseline and W12. The UCT score ranges from 0 to 16 with higher scores reflecting lower control of the disease. A score of ≥12 indicates well-controlled urticaria. | baseline and week 12 | 
| Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 16, With or Without the Presence of Angioedema | The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. | week 16 | 
| Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 20, With or Without the Presence of Angioedema | The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. | week 20 | 
| Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 24, With or Without the Presence of Angioedema | The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control | week 24 | 
| Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 28, With or Without the Presence of Angioedema | The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. | week 28 | 
| The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire | The Cu-QoL is a questionnaire collecting retrospective information over the last 2 weeks before baseline and W12. The CU-QoL total score is transformed to range from 0 to 100, with higher scores indicating worse Health Related Quality of life. | baseline and week 12 | 
| The Angioedema Quality of Life (AE-QoL) | The angioedema Quality of Life Questionnaire is a valuable tool to assess changes of QoL impairment in angioedema patients. The results of all the answered questions are summed up and transferred to a scale ranging from 0 to 100, with higher scores indicative of a higher QoL impairment | baseline and week 12 | 
| The Dermatology Life Quality Index (DLQI) | The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). | baseline and week 12 | 
| Angioedema Activity Using the Angioedema Activity Score (AAS) | The Angioedema Activity Score (AAS) was completed by patients on a daily basis. The AAS is a validated questionnaire to determine the severity and impact of the angioedema episode. Te daily AAS values are added over 7 days before baseline and W12. Weekly AAS (AAS7) scores range from 0 to 105, with higher scores indicative of a higher disease activity. | baseline and week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CHRONIC SPONTANEOUS URTICARIA, OMALIZUMAB, URTICARIA CONTROL TEST, IGE025