CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 314 enrolled
Drug / intervention
omalizumab +1 moredrug
Likely dose
omalizumab 150mgfrom 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/NCT02161562
NCT02161562Phase 3Completed
CompareCT.gov

OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in CSU Patients

Novartis Pharmaceuticals·interventional·Posted Jun 11, 2014·Updated Sep 13, 2018

In Brief

A Phase 3 clinical trial evaluating omalizumab for Chronic Spontaneous Urticaria. Completed, enrolled 314 participants across 35 sites in 8 countries.

Detailed Summary

This trial assessed the efficacy of optimized re-treatment therapy with omalizumab (150mg or 300mg) after relapse, in participants with Chronic Spontaneous Urticaria who were clinically well-controlled following their first course of treatment with omalizumab (150mg or 300mg). The study also assessed the benefit of uptitrating to 300mg dose in participants who were not well-controlled following their initial course of treatment with omalizumab 150mg, as well as the benefit of treatment extension of those patients who were not well-controlled following their initial course of treatment with omalizumab 300mg.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Spontaneous Urticaria
CountriesArgentina, Brazil, Canada, Chile, Dominican Republic, Guatemala, Mexico, Panama
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 11, 2014
Enrollment StartAug 1, 2014
Primary CompletionNov 3, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.1 years ago

Interventions

omalizumabdrug

150mg omalizumab via sub-cutaneous injection once every 4 weeks

omalizumabdrug

300mg omalizumab via sub-cutaneous injection once every 4 weeks