Trial · NCT05692180
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
NCT05692180, Phase 3, Active not recruiting, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma. Trials, record NCT05692180. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05692180
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
- NCT number
- NCT05692180
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 94 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Asthma
- Interventions
- Benralizumab, Placebo
- First posted
- 2023-01-20
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to first asthma exacerbation | From Baseline (Week 0) to End of Treatment (EOT) in DB treatment period | The effect of benralizumab on asthma exacerbations in paediatric and adolescent patients with uncontrolled asthma will be evaluated. |
| Secondary | Change from baseline, during the DB treatment period in Interviewer-Administered Version of the Asthma Control Questionnaire (ACQ-IA) | From Baseline (Week 0) to EOT in DB treatment period | The effect of benralizumab on asthma control and symptoms will be assessed. |
| Secondary | Change from baseline, during the DB treatment period in Asthma symptom score | From Baseline (Week 0) to EOT in DB treatment period | The effect of benralizumab on asthma control and symptoms will be assessed. |
| Secondary | Change from baseline, during the DB treatment period in rescue medication use | From Baseline (Week 0) to EOT in DB treatment period | The effect of benralizumab on asthma control and symptoms will be assessed. |
| Secondary | Change from baseline, during the DB treatment period in night-time awakenings due to asthma | From Baseline (Week 0) to EOT in DB treatment period | The effect of benralizumab on asthma control and symptoms will be assessed. |
| Secondary | Change from baseline, during the DB treatment period in peak expiratory flow (PEF) | From Baseline (Week 0) to EOT in DB treatment period | The effect of benralizumab on asthma control and symptoms will be assessed. |
| Secondary | Serum benralizumab trough concentration | During Day -7, Day 56, Day 112, every 16 weeks and at EOT DB treatment period | The pharmacokinetics of benralizumab will be characterised. |
| Secondary | Anti-benralizumab antibodies | During Day -7, Day 56, Day 112, every 16 weeks and at EOT DB treatment period | The immunogenicity of benralizumab will be characterised. |
| Secondary | Change from baseline, during the DB treatment period in Paediatric Asthma Quality of Life Questionnaire-Interviewer Administered (PAQLQ-IA) total score | From Baseline (Week 0) to EOT in DB treatment period | The effect of benralizumab on asthma health-related quality of life will be assessed. |
| Secondary | Change from baseline, during the DB treatment period, in spirometry, for pre-dose/pre-bronchodilator forced expiratory volume in one second (FEV1) | From Baseline (Week 0) to EOT in DB treatment period | The effect of benralizumab on pulmonary function (FEV1) will be assessed. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
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.
GET https://conductscience.org/api/trials/v1/NCT05692180
GET https://conductscience.org/api/trials/v1/NCT05692180/registered