Clinical Trial: Benralizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Efficacy and Safety of Benralizumab In the Treatment of Eosinophilic Grandulomatosis With Polyangiitis (EGPA) Study: BITE

Brief Summary: Benralizumab is a type of medicine called a monoclonal antibody that is made in the research clinic; it works by blocking a specific protein in the body called interleukin-5. The study medicine, benralizumab, is not yet approved for doctors to treat patients with EGPA. It is considered an experimental drug in this study.

Detailed Summary:

This study is open-label which means that all subjects will receive the study medication. The medicine-benralizumab-will be given to subjects in addition to the medicines they are already taking to treat their EGPA such as oral steroids (e.g. prednisone) and medicines that reduce the activity of their immune system. Drugs that are sometimes used (i.e., standard of care) to reduce the activity of the immune system in EGPA (in addition to oral steroids) include azathioprine, methotrexate, mycophenolate mofetil and cyclophosphamide. Information about how the stud drug that you get affects the subjects body and their health will be collected through a number of tests, procedures and questions.

The study medicine, benralizumab, will be given to subjects as one injection 30 mg under skin every four weeks for 12 weeks and then every 8 weeks for 16 weeks for a total of 5 treatments. During the treatment phase of this study, a study staff member will call the subjects to see how they are doing, what medications they are taking and if they are able to decrease their steroid use. The study is a total of 9 study visits in a 44 week time period. Everyone who takes part in the study will continue to receive his/her existing treatments for EGPA (although their dose of oral steroids may be reduced during the study.


Sponsor: National Jewish Health

Current Primary Outcome: All adverse events will be reported by count of events (safety and tolerability ) [ Time Frame: Up to 12 months ]

All adverse events will be reported to AstraZeneca and the IRB in accordance with the policy of National Jewish Health and the FDA. Serious adverse events, whether or not considered related to the investigational drug, will be recorded on the SAE event form will be sent to AstraZeneca within 24 hours of submission to the FDA.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in corticosteroid dosage [ Time Frame: Up to 12 months ]
    Change in steroid dose will be assessed by comparing the corticosteroid dose to subjects at the end of the steroid stable phase and compare to steroid dose at the end of treatment period.
  • Change in the rate of EGPA exacerbations during the study period. [ Time Frame: Up to 12 months ]
    Change in the rate of exacerbations will be assessed by comparing the rate of exacerbations during the study period with the rate during the washout and safety-monitoring period as well as with the self-reported rate of exacerbations from the year prior to the study.


Original Secondary Outcome: Same as current

Information By: National Jewish Health

Dates:
Date Received: December 11, 2016
Date Started: April 15, 2017
Date Completion: December 2018
Last Updated: May 8, 2017
Last Verified: May 2017