eligibility_summary
Inclusion: 6–<18 yrs with severe eosinophilic asthma ≥12 mo, on stable high‑dose ICS + ≥1 controller ≥6 mo, qualifying exacerbations (≥1 in past 12 mo or 2/yr in past 2 yrs, or on maintenance OCS/hospitalized), eos ≥300/μL or 150–299 + airway eos, pre‑BD FEV1 ≤95% or FEV1/FVC <0.85. Exclusion: other pulmonary/eosinophilic disease, life‑threatening/unstable disease, recent steroid burst or infection, malignancy, helminths, immunosuppression, recent Ig/biologics, prior benralizumab/other trials, hypersensitivity, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III DOMINICA tests benralizumab vs placebo in children (6–<18) with severe eosinophilic asthma on high‑dose ICS plus controllers. Benralizumab is an afucosylated human IgG1 monoclonal antibody (subcutaneous) that binds IL‑5 receptor alpha (IL‑5Rα) on eosinophils and basophils. It blocks IL‑5 signaling and engages FcγRIIIa on NK cells to trigger antibody‑dependent cell‑mediated cytotoxicity (ADCC), producing profound eosinophil depletion and reducing basophils, thereby attenuating type‑2/eosinophilic airway inflammation and exacerbations. Targets: IL‑5/IL‑5R pathway, eosinophils (primary), basophils, NK cell–mediated ADCC pathway. Comparator: placebo.