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Study to Evaluate Safety and Efficacy of Benralizumab in Subjects With Hypereosinophilic Syndrome

NCT02130882 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-02-08

Study results available
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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.

Conditions

  • Respiratory System Agents
  • Anti-Asthmatic Agents
  • Hematologic Diseases
  • Leukocyte Disorders
  • Hypereosinophilia

Interventions

DRUG

benralizumab

An afucosylated humanized antibody to IL-5 receptor alpha

OTHER

Placebo

A sterile solution containing 20 millimolar histidine/histidine-hydrochloride (HCl) 0.25 M trehalose dihydrate, and 0.006% (w/v) polysorbate 20, pH 6.0, in saline

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Amy D Klion, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-19
Primary Completion
2020-06-01
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02130882 on ClinicalTrials.gov