NCT04612790

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

A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab as a Treatment Option for Patients With Bullous Pemphigoid (FJORD)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Bullous pemphigoid (BP) is a rare disease mainly affecting the elderly. BP is associated with significant morbidity and increased mortality secondary to increased risk of secondary infections, comorbid conditions, and serious side effects from high-dose steroids and immunosuppressants. The aim of this study is to investigate the use of benralizumab as a treatment for patients symptomatic with Bullous Pemphigoid (BP).

Conditions

• Bullous Pemphigoid

Interventions

Type	Name	Description
BIOLOGICAL	Benralizumab	Benralizumab subcutaneously (SC) loading dose followed by repeat dosing of SC benralizumab plus Oral Corticosteroids per SoC tapering. Open-Label (OLE): after completion of the double-blind treatment period, all participants will have the option of entering an OLE period, starting at week 36 benralizumab SC until study closure.
BIOLOGICAL	Placebo	Placebo plus Oral Corticosteroids per SoC tapering. Open-Label (OLE): after completion of the double-blind treatment period, all participants will have the option of entering an OLE period, starting at week 36 benralizumab SC until study closure.

Timeline

• Start date: 2021-03-31
• Primary completion: 2023-10-26
• Completion: 2023-10-26
• First posted: 2020-11-03
• Last updated: 2024-11-29
• Results posted: 2024-11-29

Locations

39 sites across 11 countries: United States, Australia, Bulgaria, China, France, Germany, Greece, Israel, Italy, Japan, Spain

Regulatory

• FDA-regulated drug study