A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)
TerminatedPhase 2Results postedLast updated 13 March 2024
What this trial tests
Phase 2 trial testing Benralizumab in Chronic Spontaneous Urticaria in 159 participants. Terminated before completion.
Adults 18 to 130, any sex, with Chronic Spontaneous Urticaria. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Least Square (LS) Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7) at Week 12Primary· Baseline (Day -1) and Week 12
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 was defined as the sum of the daily scores for the 7 days prior to the day of randomization.
Group
Value
95% CI
Benralizumab 30 mg
-7.50
-8.94 – -6.05
Benralizumab 60 mg
-8.28
-9.76 – -6.80
Placebo
-6.49
-8.24 – -4.74
LS Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Weeks 12 and 24Secondary· Baseline (Day -1) and Weeks 12 and 24
The UPDD was completed twice daily (morning and evening) to capture key measures of urticaria disease activity including the UAS7. Participants were asked to document the number of hives they experienced on a scale ranging from 0 to 3 (where 0= none, 1= mild \[1 - 6 hives/12 hour\], 2= moderate \[7 - 12 hives/12 hour\] and 3= intense \[(\> 12 hives/12 hour\]). The UAS7 is the sum of UAS for the previous 7 days, that is, the sum of ISS7 and HSS7. The UAS7 represents urticaria severity on a scale from 0 (minimum) to 42 (maximum). Higher scores indicate greater severity of urticaria symptoms. Bas
Week 12
Group
Value
95% CI
Benralizumab 30 mg
-14.48
-17.58 – -11.38
Benralizumab 60 mg
-16.77
-19.94 – -13.59
Placebo
-12.41
-16.17 – -8.65
Week 24
Group
Value
95% CI
Benralizumab 30 mg
-17.99
-21.29 – -14.68
Benralizumab 60 mg
-19.17
-22.51 – -15.83
Placebo
-15.43
-19.43 – -11.44
LS Mean Change From Baseline in ISS7 at Week 24Secondary· Baseline (Day -1) and Week 24
The UPDD was completed twice daily (morning and evening) to capture key measures of urticaria disease activity including the 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 was defined as the sum of the daily scores for the 7 days prior to the day of randomization.
Group
Value
95% CI
Benralizumab 30 mg
-9.19
-10.77 – -7.61
Benralizumab 60 mg
-9.33
-10.93 – -7.73
Placebo
-7.57
-9.48 – -5.66
Percentage of Responders at Weeks 12 and 24Secondary· Weeks 12 and 24
Responder was defined as a participant whose condition was considered clinically well controlled with UAS7 \<=6 at specific time points. The UAS7 is the sum of UAS for the previous 7 days, that is, the sum of ISS7 and HSS7. The UAS7 represents urticaria severity on a scale from 0 (minimum) to 42 (maximum). Higher scores indicate greater severity of urticaria symptoms.
Week 12
Group
Value
95% CI
Benralizumab 30 mg
22.0
Benralizumab 60 mg
21.4
Placebo
10.0
Week 24
Group
Value
95% CI
Benralizumab 30 mg
28.8
Benralizumab 60 mg
37.5
Placebo
27.5
LS Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7) at Weeks 12 and 24Secondary· Baseline (Day -1) and Weeks 12 and 24
The UPDD was completed twice daily (morning and evening) to capture key measures of urticaria disease activity including the HSS7. Participants were asked to document the number of hives they experienced on a scale ranging from 0 to 3 (where 0= none, 1= mild \[1 - 6 hives/12 hour\], 2= moderate \[7 - 12 hives/12 hour\] and 3= intense \[(\> 12 hives/12 hour\]). The HSS7 is the sum of hives severity score for the previous 7 days. The HSS7 represents hives severity on a scale from 0 (minimum) to 21 (maximum). Higher scores indicate greater intensity of hives. Baseline was defined as the sum of th
Week 12
Group
Value
95% CI
Benralizumab 30 mg
-7.03
-8.84 – -5.22
Benralizumab 60 mg
-8.47
-10.32 – -6.62
Placebo
-5.87
-8.06 – -3.68
Week 24
Group
Value
95% CI
Benralizumab 30 mg
-8.88
-10.76 – -7.00
Benralizumab 60 mg
-9.81
-11.71 – -7.91
Placebo
-7.82
-10.09 – -5.54
Time to >=5-Point Decrease in ISS7Secondary· From Baseline (Day -1) up to Week 24
The time to \>=5-point decrease (clinically relevant decrease) in ISS7 was reported. 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.
Group
Value
95% CI
Benralizumab 30 mg
3.0
2.0 – 5.0
Benralizumab 60 mg
2.0
2.0 – 3.0
Placebo
8.0
3.0 – 11.0
Percentage of Participants With Complete UAS7 Response at Weeks 12 and 24Secondary· Weeks 12 and 24
Complete response was defined as participants with UAS7= 0 at specific time points. The UAS7 is the sum of UAS for the previous 7 days, that is, the sum of ISS7 and HSS7. The UAS7 represents urticaria severity on a scale from 0 (minimum) to 42 (maximum). Higher scores indicate greater severity of urticaria symptoms.
Week 12
Group
Value
95% CI
Benralizumab 30 mg
11.9
Benralizumab 60 mg
7.1
Placebo
10.0
Week 24
Group
Value
95% CI
Benralizumab 30 mg
16.9
Benralizumab 60 mg
21.4
Placebo
20.0
Mean Percentage of Angioedema-Free Days Over the Past 7 Days at Weeks 12 and 24Secondary· Weeks 12 and 24
The UPDD included a daily yes/no question asking whether the participant experienced angioedema during the past 24 hours. If yes, the participant was asked a follow-up question about how they treated the swelling. The percentage of angioedema-free days was calculated over the past 7 days by (number of angioedema-free days/number of non-missing responses) x 100.
Week 12
Group
Value
95% CI
Benralizumab 30 mg
77.50
± 35.990
Benralizumab 60 mg
85.63
± 32.435
Placebo
81.93
± 34.548
Week 24
Group
Value
95% CI
Benralizumab 30 mg
78.50
± 36.992
Benralizumab 60 mg
91.33
± 27.032
Placebo
86.79
± 31.798
LS Mean Change From Baseline in Urticaria Control Test (UCT) at Weeks 12 and 24Secondary· Baseline (Day -1) and Weeks 12 and 24
Urticaria disease control was assessed by the UCT using the electronic participant-reported outcome device. The UCT has a retrospective approach using a recall period of 4 weeks and responses on 5-point Likert scales with score ranging from 0 to 4 for each question. Subsequently, the scores for all 4 questions were summed up. The UCT scale range from 0 (minimum) to 16 (maximum). Higher scores indicate better disease control.
Week 12
Group
Value
95% CI
Benralizumab 30 mg
4.74
3.71 – 5.76
Benralizumab 60 mg
6.11
5.05 – 7.17
Placebo
5.02
3.78 – 6.26
Week 24
Group
Value
95% CI
Benralizumab 30 mg
5.24
4.04 – 6.45
Benralizumab 60 mg
6.87
5.65 – 8.09
Placebo
5.88
4.44 – 7.32
LS Mean Change From Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) at Weeks 12 and 24Secondary· Baseline (Day -1) and Weeks 12 and 24
The CU-Q2oL is a 23-item assessment of CSU-specific health-related quality of life. Participants were asked to rate their CSU symptoms and the impact of their symptoms over the last 2 weeks on several domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. The questions were scored as 1= not at all, 2= a little, 3= moderately, 4= very much, 5= extremely. The scores were transformed into percentages of the maximum possible score. The CU-Q2oL scale range from 0 (minimum) to 100 (maximum). Higher scores indicate greater impact of urticaria on health-related qual
Week 12
Group
Value
95% CI
Benralizumab 30 mg
-16.47
-20.10 – -12.84
Benralizumab 60 mg
-20.34
-24.09 – -16.60
Placebo
-18.10
-22.46 – -13.74
Week 24
Group
Value
95% CI
Benralizumab 30 mg
-17.60
-21.81 – -13.40
Benralizumab 60 mg
-22.11
-26.38 – -17.84
Placebo
-19.07
-24.09 – -14.05
LS Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 12 and 24Secondary· Baseline (Day -1) and Weeks 12 and 24
The DLQI is a 10-item assessment of dermatology-specific health-related quality of life. Participants were asked to rate their symptoms and the impact of their symptoms over the last week on several domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The questions (except question 7) were scored on a 4-point Likert scale: 0= not at all, 1= a little, 2= a lot, 3= very much. Scoring question 7, the first part asked: 'Over the last week, has your skin prevented you from working or studying?' Scoring was for response of 0= not relevant
Week 12
Group
Value
95% CI
Benralizumab 30 mg
-7.58
-9.18 – -5.98
Benralizumab 60 mg
-9.31
-10.96 – -7.66
Placebo
-8.06
-9.98 – -6.14
Week 24
Group
Value
95% CI
Benralizumab 30 mg
-8.13
-9.84 – -6.42
Benralizumab 60 mg
-10.25
-11.98 – -8.51
Placebo
-9.37
-11.41 – -7.33
Serum Concentration of BenralizumabSecondary· Pre-dose on Weeks 4, 12 and 24
Blood samples were collected to determine the serum concentration of benralizumab.
Week 4
Group
Value
95% CI
Benralizumab 30 mg
990.515
± 448.6799
Benralizumab 60 mg
2167.606
± 991.7509
Week 12
Group
Value
95% CI
Benralizumab 30 mg
1321.373
± 740.5070
Benralizumab 60 mg
3145.352
± 1577.6726
Week 24
Group
Value
95% CI
Benralizumab 30 mg
1372.806
± 883.5830
Benralizumab 60 mg
1638.810
± 946.9466
Placebo
NA
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Double-blind Period: Benralizumab 30 mg Q4W
Serious: 3/59 (5%)
Deaths: 0/59
Double-blind Period: Benralizumab 60 mg Q4W
Serious: 1/56 (2%)
Deaths: 0/56
Double-blind Period: Placebo
Serious: 0/40 (0%)
Deaths: 0/40
Extension Period: Benralizumab 30 mg Q4W
Serious: 0/49 (0%)
Deaths: 0/49
Extension Period: Benralizumab 30 mg Q8W
Serious: 3/54 (6%)
Deaths: 0/54
Extension Period: Placebo to Benralizumab
Serious: 1/37 (3%)
Deaths: 0/37
Serious adverse events (8 terms)
Reaction
System
Double-blind Period: Benra…
Double-blind Period: Benra…
Double-blind Period: Placebo
Extension Period: Benraliz…
Extension Period: Benraliz…
Extension Period: Placebo …
Ureterolithiasis
Renal and urinary disorders
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Biliary colic
Hepatobiliary disorders
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Hypersensitivity
Immune system disorders
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Subarachnoid haemorrhage
Nervous system disorders
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Asthma
Respiratory, thoracic and mediastinal disorders
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Urticaria
Skin and subcutaneous tissue disorders
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Meniscus injury
Injury, poisoning and procedural complications
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Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07444567 — Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit Fr
· Phase 3
· not yet recruiting
NCT06512883 — A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
· Phase 3
· recruiting
NCT06465485 — STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma
· Phase 3
· active not recruiting
NCT06385236 — Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
· Phase 4
· recruiting
NCT05966584 — A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer
· Phase 2
· terminated
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NCT07408219 — A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients
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NCT07219615 — A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
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Other AstraZeneca trials
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NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 13 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04612725.