CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 218 enrolled
Drug / intervention
Omalizumab +1 morebiological
Likely dose
Not stated in 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/NCT02329223
NCT02329223Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite H1 Antihistamine Therapy

Novartis Pharmaceuticals·interventional·Posted Dec 31, 2014·Updated Sep 21, 2016

In Brief

A Phase 3 clinical trial evaluating Omalizumab and Placebo for Chronic Spontaneous Uriticaria. Completed, enrolled 218 participants across 39 sites in 2 countries.

Detailed Summary

This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Spontaneous Uriticaria
CountriesJapan, South Korea
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 31, 2014
Enrollment StartDec 1, 2014
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 11.5 years ago

Interventions

Omalizumabbiological

Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.

Placeboother

Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.