Phase 3 Vasculitis Trial, Recruiting NCT06512883 Sponsor: AstraZeneca Condition: Vasculitis
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Phase 3 Vasculitis Trial, Recruiting

NCT06512883
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

All participants:

  • Children and teenagers between 6 and under 18 years old at the time of signing the study forms (with a caregiver also signing on their behalf)
  • Participants must weigh at least 15 kilograms (about 33 pounds)

For the EGPA group specifically:

  • Participants who are taking oral steroid medication at a stable dose (unchanged for at least 4 weeks before the study starts), within a specific dose range
  • If taking medicines that affect the immune system, the dose must have been unchanged for at least 4 weeks before the study starts

For the HES (Hypereosinophilic Syndrome) group specifically:

  • Has a confirmed HES diagnosis, meaning a history of high levels of a specific type of white blood cell (eosinophils) with no other explanation, confirmed on two separate tests at least one month apart, with evidence that these cells have affected organs
  • Currently has active HES symptoms, has had a previous flare-up, or is considered eligible based on how serious their condition is (as decided by the doctor)
  • Has a high enough level of eosinophils (a type of white blood cell) in the blood at the first study visit
  • Has tested negative for a specific genetic change linked to a different type of condition (confirm with trial site)

Who may not be able to join:

All participants:

  • Anyone who currently has cancer or has had cancer in the past
  • Anyone who has previously had a severe allergic reaction to a biologic medicine or a vaccine
  • Anyone with a known, significant existing condition affecting organs or body systems such as the kidneys, liver, brain, gut, blood, or hormonal system
  • Anyone who has already received the study drug (benralizumab) as part of another clinical trial

For the EGPA group specifically:

  • Anyone diagnosed with a related but different condition called granulomatosis with polyangiitis or microscopic polyangiitis
  • Anyone whose EGPA has gotten significantly worse or become organ-threatening within the 3 months before the study starts or up until the first dose
  • Anyone whose EGPA is considered immediately life-threatening within the 3 months before the study starts or up until the first dose

For the HES group specifically:

  • Anyone whose HES is considered life-threatening or who has life-threatening complications, as judged by the doctor
  • Anyone with high eosinophil levels of unknown cause (rather than a confirmed HES diagnosis)
  • Anyone diagnosed with a condition called systemic mastocytosis

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 1-877-240-9479

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
17 April 2025
Est. completion
20 February 2028

Where this trial is recruiting

🇧🇷 Brazil 🇨🇦 Canada 🇫🇷 France 🇮🇳 India 🇮🇱 Israel 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇱 Poland Turkey (Türkiye) 🇺🇸 United States

Primary endpoints

Number of Participants with Adverse Events (AEs); Serum Concentrations of Benralizumab

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov