CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 206 enrolled
Drug / intervention
Omalizumab +1 moredrug
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/NCT02392624
NCT02392624Phase 4Completed
CompareCT.gov

XTEND-CIU (Xolair Treatment Efficacy of Longer Duration in Chronic Idiopathic Urticaria): A Phase IV, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Omalizumab Through 48 Weeks in Patients With Chronic Idiopathic Urticaria

Genentech, Inc.·interventional·Posted Mar 19, 2015·Updated Mar 29, 2018

In Brief

A Phase 4 clinical trial evaluating Omalizumab and Placebo for Urticaria. Completed, enrolled 206 participants across 40 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrticaria
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 19, 2015
Enrollment StartMay 18, 2015
Primary CompletionMar 9, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.3 years ago

Interventions

Omalizumabdrug

Omalizumab 300 mg administered SC Q4W.

Placebodrug

Placebo matched to omalizumab administered SC Q4W.