Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU)

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.

Timeline

Start

2017-10-06

Primary completion

2020-05-01

Completion

2020-05-01

Publications

• Background Kaplan AP, Gimenez-Arnau AM, Saini SS. Mechanisms of action that contribute to efficacy of omalizumab in chronic spontaneous urticaria. Allergy. 2017 Apr;72(4):519-533. doi: 10.1111/all.13083. Epub 2017 Jan 4.
• Results Johal KJ, Chichester KL, Oliver ET, Devine KC, Bieneman AP, Schroeder JT, MacGlashan DW Jr, Saini SS. The efficacy of omalizumab treatment in chronic spontaneous urticaria is associated with basophil phenotypes. J Allergy Clin Immunol. 2021 Jun;147(6):2271-2280.e8. doi: 10.1016/j.jaci.2021.02.038. Epub 2021 Mar 10.

Drugs

Indications