A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
CLIPS
Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)
4 other identifiers
interventional
14
10 countries
15
Brief Summary
The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2025
Typical duration for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2024
CompletedFirst Posted
Study publicly available on registry
July 22, 2024
CompletedStudy Start
First participant enrolled
April 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 3, 2028
April 17, 2026
April 1, 2026
2.8 years
July 17, 2024
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants with Adverse Events (AEs)
The safety and tolerability of benralizumab will be evaluated.
From screening (Week -4 to -1) until Week 52
Serum Concentrations of Benralizumab
The PK of benralizumab will be evaluated.
Weeks 0, 12, 24, 25, 36, and 52
Secondary Outcomes (12)
EGPA Cohort: Percentage of Participants with Remission at Week 24
At Week 24
Number of Participants with Positive Antidrug Antibody (ADA)
Weeks 0, 12, 24, 36, 48, and 52
Change From Baseline in Peripheral Blood Eosinophil Count
From Baseline to Weeks 0, 12, 24, 36, 52
EGPA Cohort: Time to First EGPA Relapse
Up to 52 weeks
HES Cohort: Time to first HES worsening/flare
Up to 52 weeks
- +7 more secondary outcomes
Study Arms (1)
EGPA/HES Cohort: Benralizumab
EXPERIMENTALParticipants with greater than or equal to (\>=) 35 kg weight will receive benralizumab dose-1 and participants with less than (\<) 35 kg weight will receive benralizumab dose-2 as SC injection Q4W during the 52-week treatment period. All participants who complete the 52-week treatment period will be offered the opportunity to continue into an extension period.
Interventions
Benralizumab will be administered as SC injection on Q4W.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (15)
Research Site
Aurora, Colorado, 80045, United States
Research Site
Cincinnati, Ohio, 45229, United States
Research Site
Highland Hills, Ohio, 44106-2624, United States
Research Site
São Paulo, 01232-010, Brazil
Research Site
Toronto, Ontario, M5G1X8, Canada
Research Site
Lille, 59037, France
Research Site
Montpellier, 34295, France
Research Site
Ahmedabad, 380013, India
Research Site
Petah Tikva, 49202, Israel
Research Site
Guadalajara, 44620, Mexico
Research Site
Rotterdam, 3015 GD, Netherlands
Research Site
Kielce, 25-734, Poland
Research Site
Warsaw, 04-730, Poland
Research Site
Altındağ, 06230, Turkey (Türkiye)
Research Site
Istanbul, 34093, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2024
First Posted
July 22, 2024
Study Start
April 17, 2025
Primary Completion (Estimated)
February 21, 2028
Study Completion (Estimated)
April 3, 2028
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via there quest portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.