Trials / Terminated
TerminatedNCT04612725
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 2b Multinational, Randomised, Double-blind, Parallel- Group, 24-week Placebo-controlled Study With 28-week Extension to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 159 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The aim of this study is to investigate the use of benralizumab as treatment for patients with chronic spontaneous urticaria (CSU) who are symptomatic despite the use of antihistamines. It is proposed that benralizumab will deplete eosinophils and basophils from affected skin, improve symptoms of CSU, and improve CSU-related quality of life. This Phase 2b study is designed to evaluate induction and maintenance dosing regimens.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-10-27
- Primary completion
- 2022-10-13
- Completion
- 2023-03-28
- First posted
- 2020-11-03
- Last updated
- 2024-03-13
- Results posted
- 2024-03-13
Locations
40 sites across 7 countries: United States, Bulgaria, Germany, Japan, Poland, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04612725. Inclusion in this directory is not an endorsement.