A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria

Phase 4 Completed 206 enrolled Genentech, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48 weeks for treatment of H1 antihistamine refractory chronic idiopathic urticaria (CIU). After completing an initial 24-week open-label treatment period with omalizumab 300 milligrams (mg) every 4 weeks (Q4W), participants responding to omalizumab will be randomized at a 3:2 ratio (omalizumab:placebo) to either continue omalizumab or be transitioned to placebo for a further 24 weeks.

Timeline

Start: 2015-05-18
Primary completion: 2017-03-09
Completion: 2017-03-09

Outcome

Met primary endpoint

registry NUMBER Omalizumab (Randomized Participants): 21.0 (12.7 to 31.5) percentage of participants NUMBER Placebo (Randomized Participants): 60.4 (46.0 to 73.5) percentage of participants NCT02392624 ↗

registry analysis (superiority test); Omalizumab (Randomized Participants) vs Placebo (Randomized Participants); p <0.0001; Clinical Worsening Rate Difference -39.4 NCT02392624 ↗

Publications

Casale TB, Murphy TR, Holden M, Rajput Y, Yoo B, Bernstein JA. Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: Results from a randomized study (XTEND-CIU). J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2487-2490.e1. doi: 10.1016/j.jaip.2019.04.020. Epub 2019 Apr 26. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omalizumab	Monoclonal antibody	300 mg	Subcutaneous