eligibility_summary
Inclusion: current/ex-smoker ≥10 pack-years, moderate–very severe COPD (post-BD FEV1/FVC<0.70, FEV1≤65%), ≥2 steroid/hospitalization-treated exacerbations in 52 wks while on triple ICS/LABA/LAMA ~12 mo (stable last 3 mo), CAT≥15, eos: randomized ≥220 cells/μL (history ≥150 or repeat) or comparator <150, WOCBP negative test/contraception. Exclusion: asthma/other lung disease, unstable comorbidities, O2>4 L/min, chronic NIPPV, active infection/liver disease/TB/cancer, recent biologics/vaccines/blood products, immunosuppressants. No blood donation, contraception to 12 wks post-IP.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 2, randomized, double-blind, placebo-controlled study in eosinophilic COPD (≥220 eos/µL), with a non-eosinophilic control cohort (<150 eos/µL). Interventions: Benralizumab 100 mg SC every 4 weeks for 4 doses vs placebo, control group receives no treatment. Drug/type and mechanism: Benralizumab is a humanized IgG1 monoclonal antibody targeting the IL‑5 receptor alpha (IL‑5Rα). It depletes eosinophils (and basophils) primarily via antibody-dependent cell-mediated cytotoxicity (ADCC) by engaging NK cells, effectively shutting down IL‑5/IL‑5R signaling and eosinophil survival. Targets (cells/pathways): Eosinophils (primary), basophils, IL‑5/IL‑5R axis, ADCC via NK cells. The study also profiles effects on T cells, B cells, monocytes, granulocytes, systemic and lung (BAL) inflammatory biomarkers, leukocyte transcriptomes (RNA‑seq), and the airway/blood microbiome.