eligibility_summary
Eligibility: consent/assent, age 12–75, weight ≥40 kg. Physician‑diagnosed asthma >6 mo (or ICS/LABA >6 mo) plus reversibility (FEV1 ≥12% and ≥200 mL) or positive bronchial challenge. Severe eosinophilic asthma (EOS ≥150/μL, if 150–<300, prior ≥300 within 1 yr). On stable medium/high‑dose ICS+LABA ≥2 mo ± 1 controller (LTRA/LAMA). ≥1 documented exacerbation in prior year. Women: negative pregnancy test and highly effective contraception to 12 wks post‑dose.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06465485 (STEP), Phase 3b, single-arm in China, evaluates whether benralizumab enables step-down of asthma maintenance controllers while maintaining control in severe eosinophilic asthma. Drug/intervention: Benralizumab (Fasenra) 30 mg SC (Q4W ×3, then Q8W). Type/mechanism: Humanized, afucosylated IgG1 monoclonal antibody (biologic immunotherapy) targeting the interleukin-5 receptor alpha (IL‑5Rα). It blocks IL‑5 signaling and, via enhanced Fc binding, induces potent antibody-dependent cell-mediated cytotoxicity (ADCC) by NK cells, leading to rapid, near-complete depletion of eosinophils (and reduces basophils). Cells/pathways targeted: Eosinophils (primary), basophils, IL‑5/IL‑5Rα axis within type 2 (Th2/ILC2) inflammation, downstream suppression of eosinophil survival/activation and related airway eosinophilic inflammation.