Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Chronic Urticaria, sponsored by Teva Pharmaceuticals U.
NCT04976192 is a Phase 3 study of Chronic Urticaria that has completed, run by Teva Pharmaceuticals U. The registered enrollment target is 608 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). The trial reports 9 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The severity of the itch was recorded by the participants twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly itch score (ISS7) was defined as the sum of the available daily itch severity scores in that week, divided by the number of days for which a daily itch severity score was available, multiplied by 7. The daily ISS was calculated as the average of the morning and evening scores. The possible range of the weekly score was therefore 0 (best score) to 21 (worst
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 |
What the finished NCT04976192 record still lists
NCT04976192 is an interventional study that assigns participants to a tested intervention. The registered 608 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower).
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 lists 9 locations in 4 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04976192's enrollment target sits among peer trials
608 603rd of 2000 higher than 1,396 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02064673 · 608 participants · Phase 3
Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy
- NCT06091202 · 608 participants · Phase 3
Tele-Collaborative Outreach to Rural Patients With Chronic Pain
- NCT06098144 · 608 participants · Phase 4
Smoking Cessation Program in the Construction Sector
- NCT00823654 · 609 participants
Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI