At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 634 enrolled
Drug / intervention
CT-P39 +1 morebiological
Likely dose
CT-P39 1 mLfrom 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 Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment
In Brief
A Phase 3 clinical trial evaluating CT-P39 and EU-approved Xolair for Chronic Spontaneous Urticaria. Completed, enrolled 634 participants across 1 site.
Detailed Summary
A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic despite H1 antihistamine Treatment
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Spontaneous Urticaria
CountriesPoland
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedJun 2020
Enrollment StartDec 2020
Primary CompletionOct 2022
Study CompletionApr 2023
TodayJul 2026
First PostedJun 11, 2020
Enrollment StartDec 9, 2020
Primary CompletionOct 21, 2022
Study CompletionApr 27, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.1 years ago
Interventions
CT-P39biological
Prefilled syringe (PFS) of 1 mL solution
EU-approved Xolairbiological
Prefilled syringe (PFS) of 1 mL solution