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)

NCT04612725 ↗

Phase 2 Terminated 159 enrolled AstraZeneca IQVIA Pty Ltd · collab
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

EvaluationDrugModalityDoseRoute
Subject Benralizumab Monoclonal antibody — —

Indications