Trial · NCT04612725
A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)
NCT04612725, Phase 2, Terminated, AstraZeneca; results first posted 2024-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO). Trials, record NCT04612725. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04612725
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)
- NCT number
- NCT04612725
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 159 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- Benralizumab, Placebo and Benralizumab
- First posted
- 2020-11-03
- Last updated
- 2024-03-13
- Other registries' IDs
- eudract:2020-000169-17
- Results first posted
- 2024-03-13
- Limitations and caveats
- The study was terminated early by the sponsor as the primary analysis results did not support the continued development of benralizumab for the indication of CSU.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Least Square (LS) Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7) at Week 12 | 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. |
| Secondary | LS Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Weeks 12 and 24 | 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. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization. |
| Secondary | LS Mean Change From Baseline in ISS7 at Week 24 | 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. |
| Secondary | Percentage of Responders at Weeks 12 and 24 | 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. |
| Secondary | LS Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7) at Weeks 12 and 24 | 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 the daily scores for the 7 days prior to the day of randomization. |
| Secondary | Time to >=5-Point Decrease in ISS7 | 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. |
| Secondary | Percentage of Participants With Complete UAS7 Response at Weeks 12 and 24 | 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. |
| Secondary | Mean Percentage of Angioedema-Free Days Over the Past 7 Days at Weeks 12 and 24 | 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. |
| Secondary | LS Mean Change From Baseline in Urticaria Control Test (UCT) at Weeks 12 and 24 | 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. |
| Secondary | LS Mean Change From Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) at Weeks 12 and 24 | 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 quality of life. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Least Square (LS) Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7) at Week 12 | Baseline (Day -1) and Week 12 | The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Weeks 12 and 24 | Baseline (Day -1) and Weeks 12 and 24 | The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. Participants with data at baseline and each time point were analyzed. The overall number analyzed included those with data at baseline and at least 1 of the reported time points. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Change From Baseline in ISS7 at Week 24 | Baseline (Day -1) and Week 24 | The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Responders at Weeks 12 and 24 | Weeks 12 and 24 | The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. | percentage of participants | NUMBER |
| SECONDARY | LS Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7) at Weeks 12 and 24 | Baseline (Day -1) and Weeks 12 and 24 | The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to >=5-Point Decrease in ISS7 | From Baseline (Day -1) up to Week 24 | The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. Only participants with at least 1 \>=5-point decrease in ISS7 are analyzed. | weeks | MEDIAN |
| SECONDARY | Percentage of Participants With Complete UAS7 Response at Weeks 12 and 24 | Weeks 12 and 24 | The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. | percentage of participants | NUMBER |
| SECONDARY | Mean Percentage of Angioedema-Free Days Over the Past 7 Days at Weeks 12 and 24 | Weeks 12 and 24 | The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. Only participants with angioedema at baseline or history of angioedema are analyzed. | percentage of days | MEAN |
| SECONDARY | LS Mean Change From Baseline in Urticaria Control Test (UCT) at Weeks 12 and 24 | Baseline (Day -1) and Weeks 12 and 24 | The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Change From Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) at Weeks 12 and 24 | Baseline (Day -1) and Weeks 12 and 24 | The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group91
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Least Square (LS) Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7) at Week 12 | Benralizumab 30 mg | -7.50 | 95% Confidence Interval -8.94 to -6.05 | units on a scale | |
| Least Square (LS) Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7) at Week 12 | Benralizumab 60 mg | -8.28 | 95% Confidence Interval -9.76 to -6.80 | units on a scale | |
| Least Square (LS) Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7) at Week 12 | Placebo | -6.49 | 95% Confidence Interval -8.24 to -4.74 | units on a scale | |
| LS Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Weeks 12 and 24 | Benralizumab 30 mg | Week 12 | -14.48 | 95% Confidence Interval -17.58 to -11.38 | units on a scale |
| LS Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Weeks 12 and 24 | Benralizumab 60 mg | Week 12 | -16.77 | 95% Confidence Interval -19.94 to -13.59 | units on a scale |
| LS Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Weeks 12 and 24 | Placebo | Week 12 | -12.41 | 95% Confidence Interval -16.17 to -8.65 | units on a scale |
| LS Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Weeks 12 and 24 | Benralizumab 30 mg | Week 24 | -17.99 | 95% Confidence Interval -21.29 to -14.68 | units on a scale |
| LS Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Weeks 12 and 24 | Benralizumab 60 mg | Week 24 | -19.17 | 95% Confidence Interval -22.51 to -15.83 | units on a scale |
| LS Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Weeks 12 and 24 | Placebo | Week 24 | -15.43 | 95% Confidence Interval -19.43 to -11.44 | units on a scale |
| LS Mean Change From Baseline in ISS7 at Week 24 | Benralizumab 30 mg | -9.19 | 95% Confidence Interval -10.77 to -7.61 | units on a scale |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 results by groupParticipant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Double-blind Then Extension Period: Benralizumab 30 mg Q4W | 30 | |
| Overall Study | STARTED | Double-blind Then Extension Period: Benralizumab 30 mg Q8W | 29 | |
| Overall Study | STARTED | Double-blind Then Extension Period: Benralizumab 60 mg Q4W | 28 | |
| Overall Study | STARTED | Double-blind Then Extension Period: Benralizumab 60 mg Q8W | 28 | |
| Overall Study | STARTED | Double-blind Then Extension Period: Placebo | 40 | |
| Overall Study | Completed the Treatment Period | Double-blind Then Extension Period: Benralizumab 30 mg Q4W | 26 | |
| Overall Study | Completed the Treatment Period | Double-blind Then Extension Period: Benralizumab 30 mg Q8W | 27 | |
| Overall Study | Completed the Treatment Period | Double-blind Then Extension Period: Benralizumab 60 mg Q4W | 25 | |
| Overall Study | Completed the Treatment Period | Double-blind Then Extension Period: Benralizumab 60 mg Q8W | 28 | |
| Overall Study | Completed the Treatment Period | Double-blind Then Extension Period: Placebo | 37 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events96
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Double-blind Period: Benralizumab 30 mg Q4W | 5 | 59 | 5 |
| other | COVID-19 | Infections and infestations | Double-blind Period: Benralizumab 60 mg Q4W | 5 | 56 | 5 |
| other | COVID-19 | Infections and infestations | Double-blind Period: Placebo | 1 | 40 | 1 |
| other | COVID-19 | Infections and infestations | Extension Period: Benralizumab 30 mg Q4W | 4 | 49 | 4 |
| other | COVID-19 | Infections and infestations | Extension Period: Benralizumab 30 mg Q8W | 4 | 54 | 4 |
| other | COVID-19 | Infections and infestations | Extension Period: Placebo to Benralizumab | 5 | 37 | 5 |
| other | Nasopharyngitis | Infections and infestations | Double-blind Period: Benralizumab 30 mg Q4W | 1 | 59 | 2 |
| other | Nasopharyngitis | Infections and infestations | Double-blind Period: Benralizumab 60 mg Q4W | 4 | 56 | 4 |
| other | Nasopharyngitis | Infections and infestations | Double-blind Period: Placebo | 2 | 40 | 2 |
| other | Nasopharyngitis | Infections and infestations | Extension Period: Benralizumab 30 mg Q4W | 5 | 49 | 7 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-blind Period: Benralizumab 30 mg Q4W | 0 | 59 |
| Total, all-cause mortality | Double-blind Period: Benralizumab 60 mg Q4W | 0 | 56 |
| Total, all-cause mortality | Double-blind Period: Placebo | 0 | 40 |
| Total, all-cause mortality | Extension Period: Benralizumab 30 mg Q4W | 0 | 49 |
| Total, all-cause mortality | Extension Period: Benralizumab 30 mg Q8W | 0 | 54 |
| Total, all-cause mortality | Extension Period: Placebo to Benralizumab | 0 | 37 |
| Total, other adverse events | Double-blind Period: Benralizumab 30 mg Q4W | 14 | 59 |
| Total, other adverse events | Double-blind Period: Benralizumab 60 mg Q4W | 13 | 56 |
| Total, other adverse events | Double-blind Period: Placebo | 10 | 40 |
| Total, other adverse events | Extension Period: Benralizumab 30 mg Q4W | 16 | 49 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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