Study to Evaluate Safety and Efficacy of Benralizumab in Subjects With Hypereosinophilic Syndrome
Status:
Active, not recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
Background:
- 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.
Objective:
- To test if benralizumab can safely decrease eosinophils in people with HES.
Eligibility:
- Adults age 18-65 who have been on stable HES therapy for at least 1 month but still have
symptoms and high eosinophil levels.
Design:
- 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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)