Clinical trial NCT06512883: A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
Official title: Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Eosinophilic Granulomatosis With Polyangiitis (EGPA)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-07-22
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of study is to assess the safety, tolerability, and pharmacokinetic (PK) 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. 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.

Eligibility criteria: Inclusion Criteria:

All Cohorts:

* Male or female patients 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).

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 patients 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.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: From screening (Week -4 to -1) until Week 52
measure: Serum Concentrations of Benralizumab
timeFrame: Weeks 0, 12, 24, 25, 36, and 52
Secondary outcomes:
measure: EGPA Cohort: Percentage of Participants with Remission at Week 24
timeFrame: At Week 24
measure: Number of Participants with Positive Antidrug Antibody (ADA)
timeFrame: Weeks 0, 12, 24, 36, 48, and 52
measure: Change From Baseline in Peripheral Blood Eosinophil Count
timeFrame: From Baseline to Weeks 0, 12, 24, 36, 52
measure: EGPA Cohort: Time to First EGPA Relapse
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Sao Paulo
country: Brazil
facility: Research Site
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Guadalajara
country: Mexico
facility: Research Site
city: Altındağ
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
Study officials:
References: