At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 91 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.
A Randomized, Double-blind, Placebo-controlled, 28-week Treatment With a 8 Week Follow-up to Investigate the Impact of Omalizumab on Quality of Life Measures and the Incidence and Severity of Angioedema Despite H1-antihistamine Therapy.
In Brief
A Phase 3 clinical trial evaluating Omalizumab and Placebo for Chronic Spontaneous Urticaria and Angioedema. Completed, enrolled 91 participants across 25 sites.
Detailed Summary
This study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Spontaneous Urticaria, Angioedema
CountriesGermany
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartJan 2013
Primary CompletionMay 2014
TodayJul 2026
First PostedNov 7, 2012
Enrollment StartJan 23, 2013
Primary CompletionMay 9, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.7 years ago
Interventions
Omalizumabbiological
Humanized monoclonal antibody against human IgE
Placebodrug
Placebo to omalizumab