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NCT04976192 · ClinicalTrials.gov registry record · Phase 3
Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
A Phase 3 study of Chronic Urticaria, sponsored by Teva Pharmaceuticals U.
- Completed
- Registry status
- Phase 3
- Development phase
- 608
- Enrollment target
- 9
- Study locations
NCT04976192 is a Phase 3 study of Chronic Urticaria that has completed, run by Teva Pharmaceuticals U. The registered enrollment target is 608 participants. The trial reports 9 study locations across 4 states.
The verdict
NCT04976192, a Phase 3 study of Chronic Urticaria, has completed, sponsored by Teva Pharmaceuticals U.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 608 participants
- Enrollment target
- 9
- Study locations
Study 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.
Conditions Studied
Interventions
- COMBINATION_PRODUCT TEV-45779
- COMBINATION_PRODUCT XOLAIR® Injection
Study Locations (9)
Florida
- Site 10001 - Clearwater
- 10012 - Coral Gables
- 10006 - Kissimmee
- 10014 - Maitland
- 10005 - Miami
- 10009 - Tampa
California
- 10008 - Bakersfield
Michigan
- 10007 - Troy
Utah
- 10004 - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 608 participants |
| Start Date | 2021-08-30 |
| Est. Completion | 2024-04-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04976192
The ClinicalTrials.gov registry entry for NCT04976192 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 608 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Pharmaceuticals U, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Urticaria appearing as the primary indexed condition, and to 2 interventions - of which TEV-45779 is the first listed.
NCT04976192 reports 9 study locations spanning 4 distinct geographic areas - top geographies include Florida, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT04976192 about?
NCT04976192 is a clinical study titled "Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria". 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.
What is the current status of trial NCT04976192?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 608 participants. The study started on 2021-08-30. Estimated completion is 2024-04-05.
What conditions does trial NCT04976192 study?
This clinical trial studies the following conditions: Chronic Urticaria.
What interventions are being tested in trial NCT04976192?
The interventions under investigation include: TEV-45779 (COMBINATION_PRODUCT), XOLAIR® Injection (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04976192?
This trial is sponsored by Teva Pharmaceuticals U, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04976192 being conducted?
This trial has 9 study locations across California, Florida, Michigan, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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