Trial · NCT04612725
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 |
| SECONDARY | LS Mean Change From Baseline in Dermatology Life Quality Index (DLQI) 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 | Serum Concentration of Benralizumab | Pre-dose on Weeks 4, 12 and 24 | The Pharmacokinetic (PK) analysis set included all participants who received study drug and from whom PK blood samples were assumed not to be affected by factors such as protocol violations and who had at least 1 quantifiable serum PK observation post first dose. Placebo group samples were not analyzed at Weeks 4 and 12 as they have not received benralizumab in double-blind treatment period. | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Number of Participants With Anti-Drug Antibody (ADA) Response to Benralizumab | Pre-dose on Weeks 12 and 24 | The Safety analysis set included all participants who received at least 1 dose of study drug. Participants with data at baseline and at least 1 post baseline sample were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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