drugset / Trial / NCT04976192
Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
Phase 3
Completed
608 enrolled
Teva Pharmaceuticals USA
Teva Pharmaceuticals Development, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2021-08-30
- Primary completion
- 2024-04-05
- Completion
- 2024-04-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omalizumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Omalizumab | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | TEV-45779 | Unknown | 150 mg | Subcutaneous |
| Subject | TEV-45779 | Unknown | 300 mg | Subcutaneous |