Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU)
Status:
Completed
Trial end date:
2020-05-01
Target enrollment:
Participant gender:
Summary
This is a Phase IV, single-site study that will examine blood cells or tissue obtained from
CIU ( chronic idiopathic Urticaria) patients receiving open-label treatment with omalizumab
at the current FDA-approved dose of 300 mg/month for 12 weeks in addition to standard therapy
with anti-histamines. Results from the 3 Phase III studies in CIU patients provide evidence
that a meaningful change in symptoms is apparent at 1-2 wks. The Minimal Important Difference
(MID) is achieved by 70% of patients by 2 wks on multiple background drugs for hives. The
goal is to identity the IgE bearing cell type associated with clinical symptom change.
Phase:
Phase 4
Details
Lead Sponsor:
Johns Hopkins University
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)