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A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)

NCT04612725 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2024-03-13

Study results available
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Summary

The purpose of this study is to investigate the use of benralizumab is effective in the treatment of chronic spontaneous urticaria (CSU) who are symptomatic despite the use of antihistamines.

Conditions

Interventions

BIOLOGICAL

Benralizumab

2 induction doses of benralizumab (dose A and B) compared to placebo, and a comparison of maintenance dosing regimens (B vs A) in the 28-week extension period.

BIOLOGICAL

Placebo and Benralizumab

2 induction doses of benralizumab (dose A and B) compared to placebo, and a comparison of maintenance dosing regimens (B vs A) in the 28-week extension period.

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Sabine Altrichter, MD · Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-10-27
Primary Completion
2022-10-13
Completion
2023-03-28
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Germany
  • Japan
  • Poland
  • South Korea
  • Spain

Study Locations

More Related Trials

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 NCT04612725 on ClinicalTrials.gov