Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
Public ClinicalTrials.gov record NCT04976192. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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.
Study identification
- NCT ID
- NCT04976192
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Teva Pharmaceuticals USA
- Industry
- Enrollment
- 608 participants
Conditions and interventions
Conditions
Interventions
- TEV-45779 Combination Product
- XOLAIR® Injection Combination Product
Combination Product
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 29, 2021
- Primary completion
- Apr 4, 2024
- Completion
- Apr 4, 2024
- Last update posted
- Oct 6, 2025
2021 – 2024
United States locations
- U.S. sites
- 9
- U.S. states
- 4
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 10008 | Bakersfield | California | 93301 | — |
| Site 10001 | Clearwater | Florida | 33765 | — |
| 10012 | Coral Gables | Florida | 33134 | — |
| 10006 | Kissimmee | Florida | 34744 | — |
| 10014 | Maitland | Florida | 32751 | — |
| 10005 | Miami | Florida | 33014 | — |
| 10009 | Tampa | Florida | 33613 | — |
| 10007 | Troy | Michigan | 48084 | — |
| 10004 | Salt Lake City | Utah | 84117 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04976192, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 6, 2025 · Synced Jul 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04976192 live on ClinicalTrials.gov.