eligibility_summary
Eligibility: Adults (≥18) with endoscopy-confirmed EoE, PEC ≥15 eos/hpf in ≥2 of 3 esophageal levels, symptomatic dysphagia (≥2 days/week in prior month and ≥4 days in last 2 weeks), stable solid diet ≥2 months, inadequate/intolerant to standard care, willing to complete daily questionnaires. Exclusions: HES/EGPA, EoG/EoD, active H. pylori, select GI/bleeding disorders, recent dilation/surgery/impassable stricture, feeding tube/avoiding solids, regular antiplatelet/anticoagulant use, recent systemic immunosuppressants or biologics, recent OIT, non-stable SLIT/SCIT, recent live vaccines, severe allergy risk, prior barzolvolimab.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, randomized, double-blind, placebo-controlled trial in adults with active eosinophilic esophagitis testing barzolvolimab (CDX-0159) 300 mg subcutaneously every 4 weeks vs placebo (placebo switches to barzolvolimab after week 16). Barzolvolimab is a biological drug: a monoclonal antibody targeting KIT (CD117), the stem cell factor (SCF) receptor. Mechanism: blocks KIT/SCF signaling, leading to suppression and depletion of mast cells. Targets: mast cells via the KIT/SCF pathway, aiming to reduce mast cell–driven inflammation in EoE, with downstream decreases in mast cell mediators (e.g., tryptase, histamine) and associated eosinophilic activity.