CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 18 enrolled
Drug / intervention
Omalizumabdrug
Likely dose
Omalizumab 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03111628
NCT03111628Phase 4Completed
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Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria

Johns Hopkins University·interventional·Posted Apr 13, 2017·Updated Jun 14, 2021

In Brief

A Phase 4 clinical trial evaluating Omalizumab for Urticaria Chronic. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrticaria Chronic
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedApr 13, 2017
Enrollment StartOct 6, 2017
Primary CompletionMay 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.2 years ago

Interventions

Omalizumabdrug

omalizumab 300 mg every 4 weeks by subcutaneous injection