Optimization of Dupilumab Maintenance Dosing in Eosinophilic Esophagitis

Ki vehet részt

• Male or female ≥18 years of age
• Documented diagnosis of EoE by endoscopic biopsy, confirmed by intraepithelial eosinophilic infiltration (peak cell count ≥15 eosinophils [eos]/high-power field [hpf])
• On dupilumab therapy for a minimum of 24 weeks prior to screening
• Documented complete remission consisting of clinical (DSQ <10), endoscopic (EREFS score ≤2), and histologic remission (PEC <15 eos/hpf), confirmed at screening

Ki nem vehet részt

• Treatment with swallowed topical or systemic corticosteroids within 8 weeks prior to baseline
• Initiation of PPI therapy or any change in PPI dose within the 8 weeks prior to screening. Patients receiving PPIs must remain on same dose throughout the study
• Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening. Patients on a food-elimination diet must remain on the same diet throughout the study
• Oesophageal dilatation within the 12 weeks prior to screening
• Any contraindication or safety condition that would preclude the standard, approved use of dupilumab
• Presence of an esophageal stricture that cannot be traversed with a standard, diagnostic, 9 to 10 mm upper endoscope or any critical oesophageal stricture that requires dilation at screening
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study