Clincosm LogoSign in Get a demo

Efficacy and Safety of Omalizumab in Chronic Idiopathic Urticaria

Sponsor
Rabin Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02166151
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
23
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Omalizumab in Chronic Idiopathic Urticaria
Study Start Date :
Jul 1, 2014
Anticipated Primary Completion Date :
Jun 1, 2016
Anticipated Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Omalizumab

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with ≥ 50% Decrease in Urticaria Activity Score (UAS) [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rabin Medical Center Petah Tikva Israel 49100

    Sponsors and Collaborators

    • Rabin Medical Center

    Investigators

    • Principal Investigator: Michael David, Prof, Rabin Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael David, Prof. Michael David, Rabin Medical Center
    ClinicalTrials.gov Identifier:
    NCT02166151
    Other Study ID Numbers:
    • 0550-31 -RMC
    First Posted:
    Jun 18, 2014
    Last Update Posted:
    Jun 18, 2014
    Last Verified:
    Jun 1, 2014
    Additional relevant MeSH terms:
    Urticaria
    Chronic Urticaria

    Study Results

    No Results Posted as of Jun 18, 2014