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NCT02166151 Clinical Trial

Efficacy and Safety of Omalizumab in Chronic Idiopathic Urticaria

Chronic Idiopathic Urticaria Clinical Trial

Official title:
Efficacy and Safety of Omalizumab in Chronic Idiopathic Urticaria

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02166151
Other study ID # 0550-31 -RMC
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received May 28, 2014
Last updated June 17, 2014
Start date July 2014
Est. completion date June 2016

Study information
Verified date June 2014
Source Rabin Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Omalizimab
Omalizimab 150 mg S.C. once a month for consecutive 3 months

Locations
Country Name City State
Israel Rabin Medical Center Petah Tikva

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants with = 50% Decrease in Urticaria Activity Score (UAS) 3 months No
See also
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Completed NCT01264939 - A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists Phase 3
Completed NCT01287117 - A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment Phase 3
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Completed NCT00264303 - CUTE (Chronic Urticaria Treatment Evaluation) Phase 4
Recruiting NCT05774639 - Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria Phase 3
Completed NCT01599637 - Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment Phase 2