Efficacy and Safety Study of the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis

NCT04605094 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2023-08-31

Study results available
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Summary

The purpose of the study is to compare the efficacy and safety of benralizumab versus placebo and to compare benralizumab dosing regimens during extension period.

Conditions

Interventions

BIOLOGICAL

Benralizumab

Benralizumab by subcutaneous injection until Week 16, and then benralizumab by subcutaneous injection during the extension period.

BIOLOGICAL

Placebo / Benralizumab

Placebo by subcutaneous injection until Week 16, then benralizumab by subcutaneous injection until Week 52.

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY
  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Emma Guttman, MD, PhD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-12
Primary Completion
2022-04-25
Completion
2022-09-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Czechia
  • France
  • Poland
  • South Korea
  • Spain

Study Locations

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Entities

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 NCT04605094 on ClinicalTrials.gov