Benralizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study (BITE)
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|ClinicalTrials.gov Identifier: NCT03010436|
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Benralizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy and Safety of Benralizumab In the Treatment of Eosinophilic Grandulomatosis With Polyangiitis (EGPA) Study: BITE|
|Actual Study Start Date :||April 15, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
All subjects will receive the study medication- benralizumab
one injection 30 mg under the subjects skin every 4 weeks for 8 weeks and then every 8 weeks for 24 weeks for a total of 5 treatments.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010436
|Contact: Michael Wechsler, MDfirstname.lastname@example.org|
|United States, Colorado|
|National Jewish Health||Recruiting|
|Denver, Colorado, United States, 80206|
|Contact: Mary Gill, RN 303-398-1443 email@example.com|
|Principal Investigator:||Michael Wechsler, MD||National Jewish Health|