Status:
COMPLETED
A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
Lead Sponsor:
Genentech, Inc.
Conditions:
Chronic Idiopathic Urticaria
Eligibility:
All Genders
12-75 years
Phase:
PHASE2
Brief Summary
The study is a Phase II, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dos...
Eligibility Criteria
Inclusion
- CIU diagnosis \> 3 months (by history)
- No underlying etiology clearly defined for urticaria (main manifestation cannot be physical urticaria)
Exclusion
- Pregnant, breastfeeding, or women not taking contraception
- Patients \< 40kg
- Treatment with any investigational agent within 30 days of screening
- Recent history of drug or alcohol abuse
- Atopic dermatitis or other skin disease associated with pruritus
- Clinically relevant major systemic disease (making interpretation of the study results difficult)
- Previously treated with omalizumab (\< 12 months since last injection)
- Patients may not take during treatment period or have been taking within the past 3 months any of the following medications/treatments: regular (daily/every other day) hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, IVIG, or plasmapheresis
- Patients may not have been taking doxepin within the past 6 weeks regular (daily/every other day).
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00866788
Start Date
March 1 2009
End Date
January 1 2010
Last Update
July 11 2017
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