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Immunological Basis for Benralizumab Activity in Chronic Obstructive Pulmonary Disease (COPD)

NCT05273359 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-04-07

No results posted yet for this study

Summary

The current literature suggests that the mode of action of benralizumab is to deplete eosinophils through a mechanism of antibody-dependent cell-mediated cytotoxicity. This direct cellular cytotoxicity may not explain all of the benralizumab effects. The investigators propose a set of studies to systematically examine the spectrum of effects of this drug on the immune system.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Benralizumab

15 subjects (≥220 eosinophils/microliter) will receive benralizumab 100 mg subcutaneous injection every 4 weeks for 4 complete doses.

OTHER

Benralizumab placebo

15 subjects (\>220 eosinophils/microliter) will receive a matching benralizumab placebo subcutaneous injection every 4 weeks for 4 complete doses.

OTHER

Comparison (control) group; no intervention

15 subjects (\<150 eosinophils/microliter) will not receive any intervention.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Temple University

    lead OTHER

Principal Investigators

  • Thomas Rogers, PhD · Temple University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2024-06-30
Completion
2025-01-31
FDA Drug
Yes

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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 NCT05273359 on ClinicalTrials.gov