At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 136 enrolled
Drug / intervention
OMALIZUMABdrug
Likely dose
OMALIZUMAB 300 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.
A Phase IV, Multicenter, Single-arm and Open-label Study With Omalizumab (Xolair®) in Chronic Spontaneous Urticaria (CSU) Patients Who Remain Symptomatic Despite Antihistamine (H1) Treatment
In Brief
A Phase 4 clinical trial evaluating OMALIZUMAB for CHRONIC SPONTANEOUS URTICARIA. Completed, enrolled 136 participants across 29 sites.
Detailed Summary
Evaluate the proportion of patients with an urticaria control test \[UCT\] score of greater than or equal to 12 at Week 12.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCHRONIC SPONTANEOUS URTICARIA
CountriesFrance
Collaborators--
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartApr 2015
First PostedSep 2015
Primary CompletionJan 2016
TodayJul 2026
First PostedSep 15, 2015
Enrollment StartApr 22, 2015
Primary CompletionJan 11, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.8 years ago
Interventions
OMALIZUMABdrug
sub cutaneous injections of 300 mg every 4 weeks until Week 8.