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Regeneron, Sanofi Present Phase 3 Trial For Dupixent (Dupilumab) In Children Aged 1 To 11 Years With Eosinophilic Esophagitis

Benzinga ·  Jun 27 05:34

The trial showed a greater proportion of those receiving weight-tiered higher dose Dupixent experienced significant improvements in many key disease measures of EoE, compared to placebo at week 16.

These data showed weight-tiered higher dose dupilumab significantly improved key eosinophilic esophagitis histologic, endoscopic and cellular measures in children as young as 1 year old with sustained results for up to one year.

The trial is ongoing with a 108-week open-label extension period (Part C) to evaluate longer-term outcomes. The primary endpoint was histologic remission at 16 weeks, and secondary endpoints included assessments of endoscopic and histopathologic measures of the severity of disease along with clinical signs and symptoms of EoE.

Safety results were generally consistent with the known safety profile of Dupixent in adolescents and adults with EoE.

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