Back to resultsEfficacy and Safety of Omalizumab in Chronic Idiopathic Urticaria
Primary Purpose
Chronic Idiopathic Urticaria
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Omalizimab
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Idiopathic Urticaria
Eligibility Criteria
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
Sites / Locations
- Rabin Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Omalizumab
Arm Description
Omalizimab 150 mg S.C. once a month for consecutive 3 months
Outcomes
Primary Outcome Measures
Percentage of Participants with ≥ 50% Decrease in Urticaria Activity Score (UAS)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02166151
Brief Title
Efficacy and Safety of Omalizumab in Chronic Idiopathic Urticaria
Official Title
Efficacy and Safety of Omalizumab in Chronic Idiopathic Urticaria
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Omalizumab
Arm Type
Experimental
Arm Description
Omalizimab 150 mg S.C. once a month for consecutive 3 months
Intervention Type
Drug
Intervention Name(s)
Omalizimab
Other Intervention Name(s)
Xolair
Intervention Description
Omalizimab 150 mg S.C. once a month for consecutive 3 months
Primary Outcome Measure Information:
Title
Percentage of Participants with ≥ 50% Decrease in Urticaria Activity Score (UAS)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael David, Prof
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael David, Prof
Phone
972-3-9377435
Email
mdavid@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Michael David, Prof
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Omalizumab in Chronic Idiopathic Urticaria
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