Study to Evaluate Safety and Efficacy of Benralizumab in Subjects With Hypereosinophilic Syndrome
- Eosinophils are white blood cells that help fight infections. High eosinophil levels can damage people s organs, causing hypereosinophilic syndrome (HES). Researchers want to study if the drug benralizumab can help people with HES.
- To test if benralizumab can safely decrease eosinophils in people with HES.
- Adults age 18-65 who have been on stable HES therapy for at least 1 month but still have symptoms and high eosinophil levels.
- Participants will be screened with medical history, physical exam, and urine and blood tests. They will take simple heart and lung tests.
- Participants will also have a bone marrow biopsy. A numbing medicine is injected into the outer covering of the bone. Then a needle is inserted into the bone. A fast suction movement takes bone marrow cells.
- Phase 1: Participants will randomly receive either the study drug or placebo as an injection.
- They will have daily visits for the next 3 days, then 4 weekly visits, and then 4 biweekly visits. Each time, they will have medical history, physical exam, blood tests, and a check of side effects.
- They will receive another dose of the study drug or placebo at 1 month and 2 months after the first injection.
- Phase 2 repeats the Phase 1 schedule. All participants will receive the study drug.
- At 1 visit, participants will also receive a vaccine. At 4 visits, they will repeat the heart and lung tests. They will also have one other bone marrow biopsy.
- After week 24, participants will receive the study drug either 6 times over 6 months or twice over 6 months.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Benralizumab (MEDI-563) in Reducing Eosinophilia in Subjects With Hypereosinophilic Syndrome (HES)|
- 50 percent reduction in peripheral blood eosinophilia on stable HES background therapy [ Time Frame: 12 weeks post-initiation of study drug ] [ Designated as safety issue: No ]
- Percent reduction in peripheral blood eosinophilia [ Time Frame: 12 weeks post-initiation of study drug ] [ Designated as safety issue: No ]
- Frequency and severity of AEs [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Eosinophil count and background HES therapy at 1 year [ Time Frame: 1 year post-initiation of study drug ] [ Designated as safety issue: No ]
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Monthly benralizumab (30 mg) administered as 1 mL sc
An afucosylated humanized antibody to IL-5 receptor alpha
Placebo Comparator: 2
Monthly placebo administered as 1 mL sc
A sterile solution containing 20 mM histidine/histidine-HCl, 0.25 M trehalose dihydrate, and 0.006% (w/v) polysorbate 20, pH 6.0, in saline
Please refer to this study by its ClinicalTrials.gov identifier: NCT02130882
|Contact: Tamika S Magee, R.N.||(301) email@example.com|
|Contact: Amy D Klion, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Amy D Klion, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|