Study to Evaluate Safety and Efficacy of Benralizumab in Subjects With Hypereosinophilic Syndrome
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|ClinicalTrials.gov Identifier: NCT02130882|
Recruitment Status : Active, not recruiting
First Posted : May 6, 2014
Last Update Posted : August 6, 2020
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory System Agents Anti-Asthmatic Agents Hematologic Diseases Leukocyte Disorders Hypereosinophilia||Drug: benralizumab Other: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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)|
|Actual Study Start Date :||May 19, 2014|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Active Comparator: Drug
Benralizumab (30mg) will be administered sc every 4 weeks for 3 doses (at weeks 0, 4 and 8). Eosinophil counts will be blinded during this time and background HES therapy will not be tapered.
An afucosylated humanized antibody to IL-5 receptor alpha
Placebo Comparator: Placebo
Placebo will be administered sc every 4 weeks for 3 doses (at weeks 0, 4 and 8). Eosinophil counts will be blinded during this time and background HES therapy will not be tapered.
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
- To determine the efficacy of 3 doses of sc benralizumab in reducing eosinophilia in subjects with PDGFRA- negative HES [ Time Frame: 3 months ]50% reduction in peripheral blood eosinophilia on stable HES background therapy at 12 weeks post-initiation of study drug
- To assess the safety of sc benralizumab in reducing eosinophilia in subjects with HES To assess the effect of benralizumab on end organ manifestations of HES [ Time Frame: 3 months ]- Percent reduction inperipheral blood eosinophilia at 12 weeks post-treatment- Frequency and severity of AEs- Reduction in signs and symptoms of HES- Tissue eosinophilia- Numbers of eosinophils, mast cells and their precursors in bone marrow- Levels of markers of eosinophil and mast cell activation- Eosinophil count and background HES therapy at 1 year- PK and anti-drug antibody (ADA) levels- Eosinophil count after 24 weeks of every 8 weekbenralizumab dosing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130882
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Amy D Klion, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|