drugset / Trial / NCT04612790

A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid.

NCT04612790 ↗

Phase 3 Terminated 67 enrolled AstraZeneca
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to investigate the use of benralizumab is effective in the treatment of patients symptomatic Bullous Pemphigoid (BP).

Timeline

Start
2021-03-31
Primary completion
2023-10-26
Completion
2023-10-26

Outcome

Missed primary endpoint

Stopped: “Independent Data Monitoring Committee recommended terminating the study following a pre-planned analysis as the efficacy results did not meet the pre-defined futility guidelines. There were no new safety concerns identified from this analysis.”

registry p = 0.509; Difference in percentage of responders 6.70 (95% CI -10.90 to 24.29) NCT04612790 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Benralizumab Monoclonal antibody — Subcutaneous

Indications