NCT02166151UnknownPhase 3
Efficacy and Safety of Omalizumab in Chronic Idiopathic Urticaria
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Rabin Medical Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Percentage of Participants with ≥ 50% Decrease in Urticaria Activity Score (UAS)
Study Overview
Brief Summary
The study is designed to assess the efficacy and safety of monthly injections of Omalizumab 150 mg for 3 consecutive months, in patients with chronic idiopathic urticaria, unresponsive to convetional therapy by antihistamins or oral corticosteroids.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosis of chronic idiopathic urticaria for 3 months
- •failure on treatment with at least 2 antihistamins and systemic corticosteroids or cyclosporin
Exclusion Criteria
- •physical or cholinergic urticaria
- •past treatment in Omalizumab i nprevious year
- •parasitic infection
- •malignancy in last 5 years
- •known sensitivity to Omalizumab
Arms & Interventions
Omalizumab
Experimental
Omalizimab 150 mg S.C. once a month for consecutive 3 months
Intervention: Omalizimab (Drug)
Outcomes
Primary Outcomes
Percentage of Participants with ≥ 50% Decrease in Urticaria Activity Score (UAS)
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Michael David
Prof. Michael David
Rabin Medical Center
Study Sites (1)
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