At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 226 enrolled
Drug / intervention
Ligelizumabbiological
Likely dose
Ligelizumab 240 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.
An Open Label, Multicenter, Extension Study to Evaluate the Long-term Safety of QGE031 240 mg s.c. Given Every 4 Weeks for 52 Weeks in Chronic Spontaneous Urticaria Patients Who Completed Study CQGE031C2201
In Brief
A Phase 2 clinical trial evaluating Ligelizumab for Chronic Spontaneous Urticaria. Completed, enrolled 226 participants across 67 sites in 10 countries.
Detailed Summary
A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201
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 PostedJan 2016
Enrollment StartMay 2016
Primary CompletionMay 2019
TodayJul 2026
First PostedJan 7, 2016
Enrollment StartMay 24, 2016
Primary CompletionMay 2, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.5 years ago
Interventions
Ligelizumabbiological
QGE031 240 mg s.c. q4w