Eosinophilic Granulomatosis With Polyangiitis (EGPA)Phase 3CLIPSNCT06512883
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
A Phase 3 study testing Benralizumab in people with Eosinophilic Granulomatosis With Polyangiitis (EGPA) and Hypereosinophilia Syndrome (HES), run by AstraZeneca at 15 sites in 10 countries.
Trial summary
The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Eosinophilic Granulomatosis With Polyangiitis (EGPA), Hypereosinophilia Syndrome (HES)
- What is being tested?
- Benralizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 15 sitesin 10 countries
- Study dates
- 17 Apr 2025to 14 May 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Show all 11Show fewer
- 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.
Who cannot join
- 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:
Show all 13Show fewer
- 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.
Trial locations and contacts
15 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
15 sites in 10 countries
United States3 sites, 3 recruiting
- Recruiting
Research Site
Aurora, Colorado, 80045
- Recruiting
Research Site
Cincinnati, Ohio, 45229
- Recruiting
Research Site
Highland Hills, Ohio, 44106-2624
France2 sites, 1 recruiting
- Recruiting
Research Site
Lille, 59037
- Suspended
Research Site
Montpellier, 34295
Poland2 sites, 2 recruiting
- Recruiting
Research Site
Kielce, 25-734
- Not yet recruiting
Research Site
Warsaw, 04-730
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Research Site
Altındağ, 06230
- Recruiting
Research Site
Istanbul, 34093
Netherlands1 site, 1 recruiting
- Recruiting
Research Site
Rotterdam, 3015 GD
About this study
Official title: Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)
The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.
Read the 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:
- Screening period: 1 to 4 weeks
- Open-label treatment period: 52 weeks
- 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.
- Being tested
- Benralizumab
- Medical subject headings
- Churg-Strauss Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenralizumabDrug
Also called FASENRA
Benralizumab will be administered as SC injection on Q4W.
| Study group | Role | What they receive |
|---|---|---|
| EGPA/HES Cohort: Benralizumab | Experimental | Participants 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. Receives: Drug: Benralizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
The safety and tolerability of benralizumab will be evaluated.
Measured: From screening (Week -4 to -1) until Week 52
Serum Concentrations of Benralizumab
The PK of benralizumab will be evaluated.
Measured: Weeks 0, 12, 24, 25, 36, and 52
Secondary outcomes (12)
EGPA Cohort: Percentage of Participants with Remission 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.
Measured: At Week 24
Number of Participants with Positive Antidrug Antibody (ADA)
The immunogenicity of benralizumab will be evaluated.
Measured: Weeks 0, 12, 24, 36, 48, and 52
Change From Baseline in Peripheral Blood Eosinophil Count
The PD effect of benralizumab on peripheral blood eosinophil count will be evaluated.
Measured: From Baseline to Weeks 0, 12, 24, 36, 52
EGPA Cohort: Time to First EGPA Relapse
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.
Measured: Up to 52 weeks
HES Cohort: Time to first HES worsening/flare
The effect of benralizumab on HES worsening/flares will be evaluated.
Measured: Up to 52 weeks
HES Cohort: Percentage of participants who experience a HES worsening/flare
The effect of benralizumab on HES worsening/flares will be evaluated.
Measured: Up to 52 weeks
HES Cohort: Number of HES worsening/flares (annualised rate/year)
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).
Measured: Up to 52 weeks
HES Cohort: Percentage of Participants requiring an increase in corticosteroid dose
The effect of benralizumab on corticosteroid use will be evaluated.
Measured: Up to 52 weeks
HES Cohort: Time to first haematologic relapse
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.
Measured: Up to 52 weeks
HES Cohort: Percentage of Participants with haematologic relapse
The effect of benralizumab on haematologic measures of disease activity will be evaluated.
Measured: Up to 52 weeks
HES Cohort: Percentage of Participants who have AEC < 500 cells/μL for 24 weeks
The effect of benralizumab on haematologic measures of disease activity will be evaluated.
Measured: Up to 52 weeks
HES Cohort: Patient Global Impression of Change (PGI-C) Score
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').
Measured: Weeks 12, 24, 36 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start17 Apr 2025
- Primary completion20 Feb 2028 (estimated)
- Study completion14 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Granulomatosis With Polyangiitis (EGPA)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512883
- Sponsor's protocol ID
- D3255C00004
- Other IDs
- 2023-508533-14-00, EMEA-001214-PIP09-21-M02(EGPA), EMEA-001214-PIP04-19-M02 (HES), 2023
- Acronym
- CLIPS
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)
- ClinicalTrials.gov ID
- NCT06512883
- Acronym / sponsor ID
- CLIPS / D3255C00004
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 20 Feb 2028 (estimated)
- Study completion
- 14 May 2029 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Screening period: 1 to 4 weeks
- Open-label treatment period: 52 weeks
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGPA/HES Cohort: Benralizumab | Experimental | Drug: BenralizumabParticipants 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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).
- 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).
- 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.
Key exclusion criteria (13 listed)
- 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.
- Diagnosed with granulomatosis with polyangiitis (previously known as Wegener'granulomatosis) or microscopic polyangiitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BenralizumabAlso: FASENRABenralizumab will be administered as SC injection on Q4W. | Drug | EGPA/HES Cohort: Benralizumab |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: From screening (Week -4 to -1) until Week 52
The safety and tolerability of benralizumab will be evaluated.
Serum Concentrations of Benralizumab
Time frame: Weeks 0, 12, 24, 25, 36, and 52
The PK of benralizumab will be evaluated.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Eosinophilic Granulomatosis With Polyangiitis (EGPA)
RecruitingPhase 3
Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
Asthma, Eosinophilic Granulomatosis With Polyangiitis (EGPA)
RecruitingObservational study
Benralizumab Effectiveness in EGPA
Eosinophilic Granulomatosis With Polyangiitis (EGPA)
RecruitingObservational study
Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis
Eosinophilic Granulomatosis With Polyangiitis, Churg-Strauss Syndrome
Active, not recruitingPhase 3
Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.
Eosinophilic Granulomatous Vasculitis
Active, not recruitingPhase 3
Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA)
Eosinophilic Granulomatosis With Polyangiitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
15 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Benralizumab in people with Eosinophilic Granulomatosis With Polyangiitis (EGPA) and Hypereosinophilia Syndrome (HES), run by AstraZeneca at 15 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, France, Poland, Turkey (Türkiye), Brazil and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) (time frame: From screening (Week -4 to -1) until Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.