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Recruiting NCT06512883

A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases

Phase III Interventional Eosinophilic Granulomatosis With Polyangiitis (EGPA) Hypereosinophilia Syndrome (HES)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Benralizumab.
Who it may be relevant to
Registry conditions: Eosinophilic Granulomatosis With Polyangiitis (EGPA), Hypereosinophilia Syndrome (HES). Basic parameters: 6 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Brazil, Canada, France, India +5
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)

Overview

The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.

Detailed description

This study is open-label, multicentre, basket study to evaluate the safety, PK, pharmacodynamic (PD), efficacy, and immunogenicity of repeat dosing of benralizumab subcutaneous (SC) every 4 weeks (Q4W) in male and female children with rare eosinophilic diseases.

Paediatric participants with eosinophilic granulomatosis with polyangiitis (EGPA) will be enrolled in the first cohort.

Paediatric participants with hypereosinophilic syndrome (HES) will be enrolled in the second cohort. Additional cohorts in other eosinophilic diseases may be added in future protocol amendments.

The study consists of 3 periods:

1. Screening period: 1 to 4 weeks 2. Open-label treatment period: 52 weeks 3. Open-label extension period: at least 52 weeks (plus safety follow-up \[SFU\] weeks after last investigational product \[IP\] administration)

All eligible participants will receive benralizumab SC Q4W during the 52-week open-label treatment period.

All participants who complete the 52-week open-label treatment period on IP will be offered the opportunity to continue into an extension period. The extension period is intended to allow each participant at least an additional one year of treatment with benralizumab.

Interventions

  • Drug Benralizumab
    Benralizumab will be administered as SC injection on Q4W.

Primary outcome measures

  • Number of Participants with Adverse Events (AEs) [Time frame: From screening (Week -4 to -1) until Week 52]
  • Serum Concentrations of Benralizumab [Time frame: Weeks 0, 12, 24, 25, 36, and 52]
Secondary outcome measures (12)
  • EGPA Cohort: Percentage of Participants with Remission at Week 24 [Time frame: At Week 24]
  • Number of Participants with Positive Antidrug Antibody (ADA) [Time frame: Weeks 0, 12, 24, 36, 48, and 52]
  • Change From Baseline in Peripheral Blood Eosinophil Count [Time frame: From Baseline to Weeks 0, 12, 24, 36, 52]
  • EGPA Cohort: Time to First EGPA Relapse [Time frame: Up to 52 weeks]
  • HES Cohort: Time to first HES worsening/flare [Time frame: Up to 52 weeks]
  • HES Cohort: Percentage of participants who experience a HES worsening/flare [Time frame: Up to 52 weeks]
  • HES Cohort: Number of HES worsening/flares (annualised rate/year) [Time frame: Up to 52 weeks]
  • HES Cohort: Percentage of Participants requiring an increase in corticosteroid dose [Time frame: Up to 52 weeks]
  • HES Cohort: Time to first haematologic relapse [Time frame: Up to 52 weeks]
  • HES Cohort: Percentage of Participants with haematologic relapse [Time frame: Up to 52 weeks]
  • HES Cohort: Percentage of Participants who have AEC < 500 cells/μL for 24 weeks [Time frame: Up to 52 weeks]
  • HES Cohort: Patient Global Impression of Change (PGI-C) Score [Time frame: Weeks 12, 24, 36 and 48]

Eligibility criteria

Inclusion criteria

All Cohorts:

  • Male or female participants must be aged 6 to < 18 years of age at the time of signing the assent form and their caregiver signing the informed consent form.
  • Body weight greater than (>=) 15 kilograms (kg).

EGPA Cohort:

  • Therapy with corticosteroids: The prescribed dose of oral corticosteroids (OCS) (greater than \[>\] 0.1 milligrams per kilogram per day (mg/kg/day), max dose of 50 milligrams per day (mg/day) must be stable (that is, no adjustment of the dose) for at least 4 weeks prior to baseline (Visit 2).
  • Immunosuppressive therapy: If receiving immunosuppressive therapy, the dosage must be stable for at least 4 weeks prior to baseline (Visit 2).

HES Cohort:

  • Documented HES diagnosis, defined as history of persistent eosinophilia >1500 cells/µL without secondary cause on 2 examinations ≥1 month apart and evidence of eosinophil-mediated organ involvement.
  • Symptomatic active HES, or history of a prior flare, or considered eligible based on disease severity per investigator judgement.
  • AEC ≥1000 cells/µL at screening (Visit 1).
  • Documented negative testing for Fip1-like 1 gene fused with the platelet-derived growth factor receptor alpha gene (FIP1L1-PDGFR) fusion tyrosine kinase gene translocation.

Exclusion criteria

All Cohorts:

  • Any current malignancy or history of malignancy.
  • History of anaphylaxis to any biologic therapy or vaccine.
  • Known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory, or any other system abnormalities.
  • Previous receipt of benralizumab in an interventional clinical study.

EGPA Cohort:

  • Diagnosed with granulomatosis with polyangiitis (previously known as Wegener'granulomatosis) or microscopic polyangiitis.
  • EGPA relapse: any deterioration in EGPA and/or organ-threatening EGPA that per Investigator judgement renders participants unstable in their EGPA within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2).
  • Life-threatening EGPA: imminently life-threatening EGPA disease within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2), as per Investigator judgement.

HES Cohort:

  • Life-threatening HES or HES complications, as judged by the investigator.
  • Hypereosinophilia of unknown significance (HE-US).
  • Diagnosis of systemic mastocytosis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Research Site — Aurora
  • Research Site — Cincinnati
  • Research Site — Highland Hills
France · 2 centers
  • Research Site — Lille
  • Research Site — Montpellier
Poland · 2 centers
  • Research Site — Kielce
  • Research Site — Warsaw
Turkey (Türkiye) · 2 centers
  • Research Site — Altındağ
  • Research Site — Istanbul
Brazil · 1 center
  • Research Site — São Paulo
Canada · 1 center
  • Research Site — Toronto
India · 1 center
  • Research Site — Ahmedabad
Israel · 1 center
  • Research Site — Petah Tikva
Mexico · 1 center
  • Research Site — Guadalajara
Netherlands · 1 center
  • Research Site — Rotterdam

Identifiers

NCT: NCT06512883 · D3255C00004 · 2023-508533-14-00 · EMEA-001214-PIP09-21-M02(EGPA) · EMEA-001214-PIP04-19-M02 (HES)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗