Actively Recruiting
Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)
Led by AstraZeneca · Updated on 2026-05-29
14
Participants Needed
15
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating benralizumab in children aged 6 to under 18 years with rare eosinophilic diseases, specifically eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES). This phase 3, open-label, multicenter basket study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy, and immunogenicity of repeated subcutaneous doses of benralizumab every four weeks. Additional cohorts for other eosinophilic diseases may be added in later protocol updates. Participants are assigned to one of two dosing groups based on weight: those weighing 35 kg or more receive one dose, while those under 35 kg receive a different dose of benralizumab via subcutaneous injection every four weeks during a 52-week treatment period. Following this, participants who complete the initial treatment may continue in an open-label extension for at least another 52 weeks, allowing for at least one additional year of treatment and ongoing safety follow-up. During the study, participants will undergo a screening period lasting one to four weeks, followed by the treatment and extension phases. Researchers will monitor adverse events, serum levels of benralizumab, and various disease-specific outcomes such as remission rates, relapse times, eosinophil counts, and patient-reported impressions of change. Safety and efficacy data will be collected through scheduled visits and laboratory tests throughout the study duration, which may extend beyond two years including the extension period.
CONDITIONS
Brief Title
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 6 to under 18 years at the time of assent and caregiver consent.
- Body weight of at least 15 kilograms.
- For EGPA cohort: Stable oral corticosteroid dose (>0.1 mg/kg/day, max 50 mg/day) for at least 4 weeks before baseline.
- For EGPA cohort: Stable dose of immunosuppressive therapy for at least 4 weeks before baseline if receiving.
- For HES cohort: Documented diagnosis with persistent eosinophilia >1500 cells/µL on two exams at least 1 month apart and evidence of organ involvement.
- For HES cohort: Symptomatic active disease, prior flare history, or eligibility based on severity.
- For HES cohort: Absolute eosinophil count ≥1000 cells/µL at screening.
- For HES cohort: Negative test for FIP1L1-PDGFR fusion gene.
You will not qualify if you...
- Any current or past malignancy.
- History of anaphylaxis to any biologic therapy or vaccine.
- Known significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological, respiratory, or other system disorders.
- Prior participation with benralizumab in an interventional clinical study.
- For EGPA cohort: Diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis.
- For EGPA cohort: EGPA relapse or unstable disease within 3 months before screening and first dose.
- For EGPA cohort: Imminently life-threatening EGPA within 3 months before screening and first dose.
- For HES cohort: Life-threatening HES or complications.
- For HES cohort: Hypereosinophilia of unknown significance.
- For HES cohort: Diagnosis of systemic mastocytosis.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 1 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive benralizumab as a subcutaneous injection every 4 weeks for 52 weeks to evaluate safety, pharmacokinetics, and efficacy.
Monthly visits for 52 weeks
Duration - At least 52 weeks
Participants who complete the initial 52-week treatment period may continue receiving benralizumab for at least an additional 52 weeks.
Monthly visits for at least 52 weeks
Trial Site Locations
Total: 15 locations
1
Research Site
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Research Site
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
3
Research Site
Highland Hills, Ohio, United States, 44106-2624
Actively Recruiting
4
Research Site
São Paulo, Brazil, 01232-010
Actively Recruiting
5
Research Site
Toronto, Ontario, Canada, M5G1X8
Actively Recruiting
6
Research Site
Lille, France, 59037
Not Yet Recruiting
7
Research Site
Montpellier, France, 34295
Not Yet Recruiting
8
Research Site
Ahmedabad, India, 380013
Not Yet Recruiting
9
Research Site
Petah Tikva, Israel, 49202
Not Yet Recruiting
10
Research Site
Guadalajara, Mexico, 44620
Actively Recruiting
11
Research Site
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
12
Research Site
Kielce, Poland, 25-734
Not Yet Recruiting
13
Research Site
Warsaw, Poland, 04-730
Not Yet Recruiting
14
Research Site
Altındağ, Turkey (Türkiye), 06230
Actively Recruiting
15
Research Site
Istanbul, Turkey (Türkiye), 34093
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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