drugset / Trial / NCT04612725
A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to investigate the use of benralizumab is effective in the treatment of chronic spontaneous urticaria (CSU) who are symptomatic despite the use of antihistamines.
Timeline
- Start
- 2020-10-27
- Primary completion
- 2022-10-13
- Completion
- 2023-03-28
Outcome
Missed primary endpoint
Stopped: “Study did not meet primary endpoint”
registry analysis (superiority test); Benralizumab 30 mg vs Placebo; p = 0.3824; LS mean difference -1.01 (95% CI -3.28 to 1.26) NCT04612725 ↗
registry analysis (superiority test); Benralizumab 60 mg vs Placebo; p = 0.1244; LS mean difference -1.79 (95% CI -4.09 to 0.50) NCT04612725 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benralizumab | Monoclonal antibody | — | — |