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NCT04612725 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by AstraZeneca.

Terminated
Registry status
Phase 2
Development phase
159
Enrollment target

NCT04612725: Clinical Trial Phase 2 study, sponsored by AstraZeneca.

NCT04612725 is a Phase 2 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 159 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04612725, a Phase 2 study, was terminated before completion, sponsored by AstraZeneca.

TERMINATED
Registry status
Phase 2
Development phase
159 participants
Enrollment target

Study 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.

Primary Outcome

The urticaria participant daily diary (UPDD) was completed twice daily (morning and evening) to capture key measures of urticaria disease activity including the itch severity score (ISS). The ISS represents severity on a scale ranging from 0 to 3 (where 0= none, 1= mild, 2= moderate and 3= severe). The ISS7 is the sum of ISS for the previous 7 days. The ISS7 represents itch severity on a scale ranging from 0 (minimum) to 21 (maximum). Higher scores indicate greater intensity of itch. Baseline wa

Interventions

  • BIOLOGICAL Benralizumab
  • BIOLOGICAL Placebo and Benralizumab

Trial Details

FieldValue
Enrollment Target 159 participants
Start Date 2020-10-27
Est. Completion 2023-03-28
Phase Phase 2
AstraZeneca

1,285 total trials

Why NCT04612725 stopped before completion

NCT04612725 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).

The record links to 0 conditions, and to 2 interventions - of which Benralizumab is the first listed.

NCT04612725 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04612725 about?

NCT04612725 is a clinical study titled "A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)". 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.

What is the current status of trial NCT04612725?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 159 participants. The study started on 2020-10-27. Estimated completion is 2023-03-28.

What interventions are being tested in trial NCT04612725?

The interventions under investigation include: Benralizumab (BIOLOGICAL), Placebo and Benralizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT04612725?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04612725's enrollment target sits among peer trials

159 442nd of 2000 higher than 1,558 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04612725, the US trial registry maintained by the National Library of Medicine. NCT04612725 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.