Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)
Primary Objective
To evaluate the safety and tolerability of benralizumab
Description
open-label, single treatment arm, multicentre, basket study to evaluate safety, PK, PD, efficacy, and immunogenicity of repeat dosing of benralizumab
Details
Age
Child and Teen
Eligibility
Age 6 to <18 years of age, greater than or equal to 15kg, with a documented EGPA diagnosis for > 6 months before screening visit with hsitory or presence of asthma and eosinophilia.Documentation of 2: Biopsy with histopathological evidence of eosinophilic disease, neuropathy, pulmonary infiltrates, sino-nasal abnormality, cardiomyopathy, glomerulonephritis, alveolar haemorrhage, palpable purpura, positive ANCA test for MPO or PR3.
Locations
Childrens Hospital Colorado
Principal Investigator
Jessica Bloom
Study ID
Protocol Number: 24-0657
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