At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 608 enrolled
Drug / intervention
TEV-45779 +1 morecombination
Likely dose
TEV-45779 150 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.
Study to Evaluate the Efficacy, Safety, Tolerability, and Immunogenicity of TEV-45779 Compared to XOLAIR (Omalizumab) in Patients With Chronic Idiopathic/Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine (H1) Treatment.
In Brief
A Phase 3 clinical trial evaluating TEV-45779 and XOLAIR® Injection for Chronic Urticaria. Completed, enrolled 608 participants across 9 sites.
Detailed Summary
The purpose of the study is to compare the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of TEV-45779 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic on H1 antihistamine treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Urticaria
CountriesUnited States
CollaboratorsTeva Pharmaceuticals Development, Inc.
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedJul 2021
Enrollment StartAug 2021
Primary CompletionApr 2024
TodayJul 2026
First PostedJul 26, 2021
Enrollment StartAug 30, 2021
Primary CompletionApr 5, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 4.9 years ago
Interventions
TEV-45779combination
TEV-45779 (Omalizumab) solution for injection 150 mg/mL prefilled syringe
XOLAIR® Injectioncombination
XOLAIR (omalizumab) injection is supplied as a single dose PFS. Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution.