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

NCT04612790 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2024-11-29

Study results available
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Summary

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

Conditions

  • Bullous Pemphigoid

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2023-10-26
Completion
2023-10-26
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • China
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Spain

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04612790 on ClinicalTrials.gov