At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 382 enrolled
Drug / intervention
QGE031 +2 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 Multi-center, Randomized, Double-blind, Placebo, and Active-controlled Phase 2b Dose-finding Study of QGE031 as add-on Therapy to Investigate the Efficacy and Safety in Patients With Chronic Spontaneous Urticaria (CSU)
In Brief
A Phase 2 clinical trial evaluating QGE031, Omalizumab, and 1 other intervention for Chronic Spontaneous Urticaria. Completed, enrolled 382 participants across 82 sites in 10 countries.
Detailed Summary
This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Spontaneous Urticaria
CountriesAustralia, Canada, Germany, Greece, Japan, Russia, Spain, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartJul 2015
Primary CompletionNov 2016
Study CompletionJun 2017
TodayJul 2026
First PostedJun 22, 2015
Enrollment StartJul 15, 2015
Primary CompletionNov 2, 2016
Study CompletionJun 12, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.0 years ago
Interventions
QGE031biological
Omalizumabbiological
Placeboother