Trial · NCT06512883
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
NCT06512883, Phase 3, Recruiting, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases. Trials, record NCT06512883. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06512883
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
- NCT number
- NCT06512883
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 14 participants, estimated
- Lead sponsor
- AstraZeneca
- Conditions
- Eosinophilic Granulomatosis With Polyangiitis (EGPA), Hypereosinophilia Syndrome (HES)
- Interventions
- Benralizumab
- First posted
- 2024-07-22
- 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 | Number of Participants with Adverse Events (AEs) | From screening (Week -4 to -1) until Week 52 | The safety and tolerability of benralizumab will be evaluated. |
| Primary | Serum Concentrations of Benralizumab | Weeks 0, 12, 24, 25, 36, and 52 | The PK of benralizumab will be evaluated. |
| Secondary | EGPA Cohort: Percentage of Participants with Remission at Week 24 | At Week 24 | Remission defined as Paediatric Vasculitis Activity Score (PVAS) = 0 and oral corticosteroid (OCS) intake less than or equal to (\<=) 0.1 mg/kg/day. |
| Secondary | Number of Participants with Positive Antidrug Antibody (ADA) | Weeks 0, 12, 24, 36, 48, and 52 | The immunogenicity of benralizumab will be evaluated. |
| Secondary | Change From Baseline in Peripheral Blood Eosinophil Count | From Baseline to Weeks 0, 12, 24, 36, 52 | The PD effect of benralizumab on peripheral blood eosinophil count will be evaluated. |
| Secondary | EGPA Cohort: Time to First EGPA Relapse | Up to 52 weeks | The efficacy of benralizumab on time to first relapse will be assessed. EGPA relapse will be defined as worsening or persistence of active disease since the last visit characterized by: a) Active vasculitis (PVAS \> 0); OR b) Worsening of asthma symptoms (based on Asthma Control Questionnaire - Interviewer Administered \[ACQ-IA\]); OR c) Active nasal and/or sinus disease with worsening in at least one sino-nasal symptom question warranting any of the following: 1) Increase OCS; OR 2) Increase/addition of immunosuppressive medication; OR 3) Hospitalisation related to EGPA worsening. |
| Secondary | HES Cohort: Time to first HES worsening/flare | Up to 52 weeks | The effect of benralizumab on HES worsening/flares will be evaluated. |
| Secondary | HES Cohort: Percentage of participants who experience a HES worsening/flare | Up to 52 weeks | The effect of benralizumab on HES worsening/flares will be evaluated. |
| Secondary | HES Cohort: Number of HES worsening/flares (annualised rate/year) | Up to 52 weeks | The effect of benralizumab on HES worsening/flares will be evaluated. The annualised HES worsening/flare rate will be calculated as follows: The total number of flares \*365.25 / total duration of follow-up in the treatment period (days). |
| Secondary | HES Cohort: Percentage of Participants requiring an increase in corticosteroid dose | Up to 52 weeks | The effect of benralizumab on corticosteroid use will be evaluated. |
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/NCT06512883
GET https://conductscience.org/api/trials/v1/NCT06512883/registered