Trial · NCT06512883
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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. |
| Secondary | HES Cohort: Time to first haematologic relapse | Up to 52 weeks | The time to first haematologic relapse will be defined as the time from first dose of IP to the first post baseline visit with Absolute eosinophil count \[AEC\] ≥ 1000 cells/uL. |
| Secondary | HES Cohort: Percentage of Participants with haematologic relapse | Up to 52 weeks | The effect of benralizumab on haematologic measures of disease activity will be evaluated. |
| Secondary | HES Cohort: Percentage of Participants who have AEC < 500 cells/μL for 24 weeks | Up to 52 weeks | The effect of benralizumab on haematologic measures of disease activity will be evaluated. |
| Secondary | HES Cohort: Patient Global Impression of Change (PGI-C) Score | Weeks 12, 24, 36 and 48 | The effect of benralizumab on participant/caregiver reported measures of disease severity and health status will be assessed. The PGI-C instrument captures the participant's overall evaluation of response to treatment, and rated on a 7-point PGI-C scale ranging from 1 ('much better') to 7 ('much worse'). |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT06512883/registered