Efficacy and Safety of Omalizumab in Chronic Idiopathic Urticaria

Phase 3

• Conditions: Chronic Idiopathic Urticaria
• Interventions: Drug: Omalizimab

• Registration Number: NCT02166151
• Lead Sponsor: Rabin Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-28
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-17
• Last Update Submitted: 2014-06-17
• Study First Posted: 2014-06-18
• Last Update Posted: 2014-06-18
• Study Start: 2014-07
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omalizumab	Omalizimab	Omalizimab 150 mg S.C. once a month for consecutive 3 months

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with ≥ 50% Decrease in Urticaria Activity Score (UAS)	3 months

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel